Casirivimab

An anti-Spike (SARS-CoV-2) antibody.

Phase of research

Emergency use authorization

How it helps

Antiviral

Drug status

Experimental

52
Supporting references
0
Contradictory references
38
AI-suggested references
20
Clinical trials

General information

Casirivimab is a fully human monoclonal antibody targeting and neutralizing SARS-CoV-2 Spike protein (Hansen et al., 2020).

On November 21, 2020, FDA issued an emergency use authorization for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.

The drug is used as a component of an antibody cocktail (in combination with imdevimab) authorized for the treatment of COVID-19. It is marketed under names REGEN-COV or Ronapreve. More information on the authorization is provided here.

Casirivimab on DrugBank
Casirivimab on Wikipedia

 


Synonyms

REGN10933


Marketed as

REGEN-COV (co-packaged with imdevimab); RONAPREVE (co-packaged with imdevimab)

 


Supporting references

Link Tested on Impact factor Notes Publication date
SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies
Spike protein RNA Small molecule Peptide In vitro Antibody Mixed substance
Caco-2 cells; Vero cells; Sera of vaccinated individuals; (VSV) SARS-CoV-2 Spike-pseudotyped virus (WT, B.1.1.7, B.1.351, ant P.1 variants) 38.64

Casirivimab displayed in vitro inhibition of SARS-CoV-2 Spike-pseudotyped virus infection for all tested emergent Spike variants (B.1.1.7, B.1.351, and P.1); however, the efficacy against B.1.351 and P.1 variants was lower.

Mar/20/2021
Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies
Spike protein Antibody
Vero E6 cells 41.85

REGN10987+REGN10933 antibody cocktail

Nov/23/2020
Reduced neutralization of SARS-CoV-2 B.1.1.7 variant by convalescent and vaccine sera
Spike protein Spike variant Crystallization Protein factor In vitro Mechanism Antibody
in vitro biophysical assay; crystallization; sera of COVID-19 convalescent patients or vaccinated adults; Vero cells; SARS-CoV-2 (SARS-CoV-2/human/AUS/VIC01/2020 and SAR-CoV-2/B.1.1.7) 41.58

The antibody displayed only a slight reduction in B.1.1.7 variant neutralization. 

Feb/18/2021
Reduced neutralization of SARS-CoV-2 B.1.617 by vaccine and convalescent serum
Spike protein RNA DNA Spike variant Crystallization Biophysical assay Protein factor In vitro Antibody Mixed substance
in vitro biophysical assay; crystallization; sera of COVID-19 convalescent patients and vaccinated adults; Vero cells; HEK293T/17-hACE2 cells; SARS-CoV-2 (Victoria, Alpha, Beta, and Delta); (HIV-1) SARS-CoV-2 Spike-pseudotyped virus (various variants) 41.58

The antibody neutralized the Delta variant of SARS-CoV-2 in vitro. 

Jun/17/2021
B.1.526 SARS-CoV-2 Variants Identified in New York City are Neutralized by Vaccine-Elicited and Therapeutic Monoclonal Antibodies
Spike protein Spike variant Protein factor In vitro Antibody
in silico; ACE2.293T cells; lentiviral SARS-CoV-2 pseudotyped viruses (D614G and Iota strains) 7.87

Although a significant decrease was observed in the antibody’s capacity to neutralize the Iota strain of SARS-CoV-2 compared to the D614G strain, it retained some activity in vitro. The antibody was able to fully neutralize the Iota strain when combined with Imdevimab. 

Jul/27/2021
Cocktail of REGN Antibodies Binds More Strongly to SARS-CoV-2 Than Its Components, but the Omicron Variant Reduces Its Neutralizing Ability
Spike protein Spike variant Protein factor Antibody In silico
In silico 2.99

Predicted to bind SARS-CoV-2 Spike RBD more potently than imdevimab. The combined formulation (REGEN-COV) is predicted to display synergy of its components in RBD-binding capacity. 

Apr/11/2022
Neutralizing Monoclonal Antibodies for Coronavirus Disease 2019 (COVID-19) in Pregnancy
Spike protein Outpatients Protein factor Case series Antibody Moderate severity Mild severity
Pregnant patients 7.66

Pregnant women with mild to moderate COVID-19 infused with monoclonal antibodies (bamlanivimab and etesevimab – 1 patient or casirivimab and imdevimab – 14 patients) had generally favourable outcomes. Some of the patient experienced adverse reactions, however. Sample size: 15 (pooled with patients treated with other mAbs). 

Mar/01/2022
Monoclonal antibody treatment for COVID-19 in solid organ transplant recipients
Spike protein Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
Solid organ transplant recipients 2.23

Solid organ transplant recipients with mild to moderate COVID-19 might benefit from an early monoclonal antibody treatment (casirivimab and imdevimab or bamlanivimab). The difference in 30-day hospitalization rate between the treatment group and the control group was not statistically significant, however. Sample size: 93 + 72 control. Main outcome: Hospitalization within 30 days from COVID-19 diagnosis.

Nov/17/2021
Monoclonal Antibody Therapy for COVID-19 in Solid Organ Transplant Recipients
Spike protein Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
Solid organ transplant recipients 3.84

Solid organ transplant recipients with mild to moderate COVID-19 were observed to have generally favourable outcomes after monoclonal antibody treatment (casirivimab and imdevimab or bamlanivimab). Sample size: 73. 

Jun/07/2021
Effectiveness of Severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Infusions in High-Risk Outpatients
Spike protein Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
High-risk outpatients 3.84

High-risk outpatients treated with monoclonal antibodies were in a lower risk of hospitalization or death due to COVID-19. The treatment safety profile was considered acceptable. Sample size: 200 (pooled with patients treated with other mAbs) + 200 control. Dosage: 2400 mg IV (combined with imdevimab). Main outcome: A composite of COVID-19–related hospitalizations and ED visits within 29 days post-mAb administration (post-initial COVID-19 diagnosis for the control).

Jun/04/2021
Treatment with anti-SARS-CoV-2 monoclonal antibodies in pregnant and postpartum women: first experiences in Florence, Italy
Spike protein Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
Pregnant and postpartum women 3.55

The administration of casirivimab/imdevimab in pregnant and postpartum women led to recovery. Sample size: 10. Dosage: A combined dose of 2.4 g (outpatients) or 8 g (inpatients). 

Mar/07/2022
Efficacy of Licensed Monoclonal Antibodies and Antiviral Agents against the SARS-CoV-2 Omicron Sublineages BA.1 and BA.2
Spike protein 3CLpro RdRpol Spike variant Protein factor Small molecule In vitro Antibody
Vero E6 cells; SARS-CoV-2 live virus (strains B.1 (D614G) wild type, Delta, and Omicron BA.1 and BA.2) 5.05

The sera from casirivimab/imdevimab combination-treated individuals displayed in vitro activity against the wild type, Delta, and Omicron BA.2 strains (but not BA.1). 

Jun/23/2022
Evaluation of Monoclonal Antibodies in Preventing Hospitalizations, Emergency Department Visits, and Mortality in High-Risk COVID-19 Patients
Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study
High-risk COVID-19 patients

Significantly lower rates of hospitalization, emergency department visits, and mortality within 28 days of a positive COVID-19 test were observed among the high-risk patients treated with monoclonal antibodies, compared to those who were not. Sample size: 568 (data pooled for patients receiving bamlanivimab or casirivimab/imdevimab) + 1044 control. 

Mar/04/2022
Casirivimab–Imdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19
Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study
High-risk COVID-19 patients 17.03

The treatment of high-risk patients using casirivimab/imdevimab combination was associated with lower rates of hospitalization at all selected time points. Sample size: 696 +696 control. Dosage: 1200 mg infusion of each antibody formulation. Main outcome: Hospitalization rates at days 14, 21 and 28 after infusion.

Jan/23/2023
Casirivimab/imdevimab for active COVID-19 pneumonia persisted for nine months in a patient with follicular lymphoma during anti-CD20 therapy
Spike protein Protein factor Case report Antibody
A persistent COVID-19 patient with follicular lymphoma on an anti-CD20 therapy 1.36

The treatment of a persistent (258 days) COVID-19 patient with follicular lymphoma on an anti-CD20 therapy using casirivimab/imdevimab combination led to negative RT-PCR conversion and clinical improvement. Sample size: 1. 

Jun/30/2022
The impact of casirivimab-imdevimab antibody cocktail in patients amidst and post COVID 19 treatment: A retro-prospective comparative study in India
Spike protein Protein factor Antibody Cohort study
High-risk COVID-19 patients

Clinical benefit was observed in the casirivimab/imdevimab combination-treated high-risk patients. Sample size: 79 +73 control. 

Jan/17/2022
Real-world clinical outcomes of treatment with casirivimab-imdevimab among patients with mild-to-moderate coronavirus disease 2019 during the Delta variant pandemic
Spike protein Spike variant Protein factor Antibody Moderate severity Mild severity Cohort study
Patients 3.74

Casirivimab/imdevimab combination treatment was an independent factor for preventing clinical deterioration in mild or moderate COVID-19 patients during the Delta strain surge in Japan. Sample size: 314 + 635 control. Main outcome: Clinical deterioration.

May/09/2022
Effectiveness of Casirivimab-Imdevimab and Sotrovimab During a SARS-CoV-2 Delta Variant Surge
Spike protein Spike variant Outpatients Protein factor Randomized controlled double-blind trial Antibody Moderate severity Mild severity Cohort study
Outpatients 8.48

Casirivimab/imdevimab combination treatment was associated with a reduced risk of death or hospitalization in mild or moderate COVID-19 patients during the Delta strain surge. Sample size: 1104 sotrovimab + 2454 casirivimab and imdevimab + 2046 control. Main outcome: Hospitalization or death within 28 days (cohort study part); hospital-free days within 28 days (comparative effectiveness trial part).

Jul/14/2022
Rates of Severe Outcomes After Bamlanivimab-Etesevimab and Casirivimab-Imdevimab Treatment of High-Risk Patients With Mild to Moderate Coronavirus Disease 2019
Spike protein Spike variant Protein factor Antibody Moderate severity Mild severity Cohort study
High-risk COVID-19 patients 7.62

Bamlanivimab/etesevimab combination treatment resulted in significantly lower frequency of severe clinical outcomes compared to the casirivimab/imdevimab combination treatment in high-risk mild or moderate COVID-19 patients in the period of the wild-type/Delta strain prevalence. However, casirivimab/imdevimab treatment alone was associated with low rates of severe disease, too. Sample size: 181 + 500 bamlanivimab/etesevimab for comparison. Dosage: 1200 mg IV. Main outcome: Severe outcomes by day 30.

Feb/22/2022
Impact of Casirivimab-Imdevimab on Severe Acute Respiratory Syndrome Coronavirus 2 Delta Variant Nasopharyngeal Virus Load and Spike Quasispecies
Spike protein Spike variant Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
Outpatients 3.84

The combined treatment using casirivimab and imdevimab in mild to moderate COVID-19 patients infected with the Delta strain of SARS-CoV-2 generally led to a significant reduction of viral loads in 7 days. Mutational escape was not observed. Sample size: 50. Dosage: 1200 mg IV. 

Feb/21/2022
A Programmatic Response, Including Bamlanivimab or Casirivimab-imdevimab Administration, Reduces Hospitalization and Death in COVID-19 Positive Abdominal Transplant Recipients
Spike protein Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
Abdominal organ transplant recipient outpatients 4.94

Monoclonal antibody treatment targeting SARS-CoV-2 Spike (pooled analysis for bamlanivimab and casirivimab/imdevimab) led to improved clinical outcomes in abdominal transplant recipients with COVID-19 (not requiring hospital admission at baseline). Sample size: 34. Dosage: 1200 mg IV. 

Feb/01/2022
Emulation of a Target Trial From Observational Data to Compare Effectiveness of Casirivimab/Imdevimab and Bamlanivimab/Etesevimab for Early Treatment of Non-Hospitalized Patients With COVID-19
Spike protein Spike variant Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
Outpatients 7.56

The treatment using casirivimab and imdevimab was safe and tolerable and it was associated with reduced risk of clinical progression, compared to bamlanivimab and etesevimab combined treatment. Neither treatment reduced viral loads in 7 days significantly. Sample size: With follow-up data: 111 bamlanivimab and etesevimab + 127 casirivimab and imdevimab. Dosage: 1200 mg IV. 

Apr/20/2022
Successful use of casirivimab/imdevimab anti-spike monoclonal antibodies to enhance neutralizing antibodies in a woman on anti-CD20 treatment with refractory COVID-19
Spike protein Protein factor Case report Antibody
A persistent COVID-19 patient on an anti-CD20 therapy 2.21

A patient receiving anti-CD20 monoclonal antibody treatment with refractory COVID-19 was successfully treated using casirivimab and imdevimab. Sample size: 1. 

Mar/20/2022
Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial
Spike protein Outpatients Asymptomatic Protein factor Phase III clinical trial Randomized controlled double-blind trial Antibody
Healthy household contacts of infected individuals 25.07

A single subcutaneous injection of casirivimab/imdevimab provided significant protection against SARS-CoV-2 infection in the community setting. The analysis covers a 8-month pre-Omicron period. Sample size: 841 + 842 placebo. Dosage: 600 mg subcutaneously. 

Jul/05/2022
Real-world effectiveness of casirivimab plus indevimab in a dedicated ambulatory unit created for patients with early COVID-19 during a massive delta variant wave
Spike protein Spike variant Outpatients Protein factor Antibody Moderate severity Mild severity Cohort study
High-risk outpatients 3.27

Early administration of casirivimab and imdevimab in high-risk outpatients infected with SARS-CoV-2 Delta variant resulted in a clinical outcome considered to show the antibodies’ efficacy. Sample size: 217. Dosage: 1200 mg IV. 

Jul/27/2022
Characterization and antiviral susceptibility of SARS-CoV-2 Omicron BA.2
3CLpro Spike variant Protein factor Small molecule Animal model In vitro Antibody
VeroE6/TMPRSS2 cells; Syrian hamsters (K18-hACE2 lines); K18-hACE2 C57BL/6J mice; BALB/c mice; SARS-CoV-2 live virus (D614G, Delta, Omicron BA.1, Omicron BA.1.1, and Omicron BA.2 (various isolates)) 49.96

The antibody cocktail Casirivimab/Imdevimab administered on day one post Syrian hamster viral challenge significantly decreased the viral titres of SARS-CoV-2 Omicron BA.2 in animals’ lungs. No significant decrease was observed in the case of nasal turbinates, however. 

May/16/2022
Antibody-Mediated Neutralization of Authentic SARS-CoV-2 B.1.617 Variants Harboring L452R and T478K/E484Q
Spike protein RNA Spike variant In vitro Antibody Mixed substance
Caco-2 cells; A549-AT cells; SARS-CoV-2 variants Kappa, Delta, FFM1 (B), FFM7 (B.1), Alpha and Epsilon 5.05

The Kappa variant of SARS-CoV-2 (E484Q) shows reduced neutralization by casirivimab. However, casirivimab/imdevimab treatment is effective against Kappa and Delta variants B.1.617. 

Aug/26/2021
Use of monoclonal antibody therapy for nosocomial SARS-CoV-2 infection in patients at high risk for severe COVID-19: experience from a tertiary-care hospital in Germany
Spike protein Severe severity Protein factor Case series Antibody
High-risk patients

Administration of monoclonal antibodies significantly prevented progression in asymptomatic patients infected with SARS-CoV-2. Sample size: 43. Dosage: 2 400 mg in 250 mL normal saline and administered as a single intravenous infusion for approximately 1 h. 

Jul/09/2021
Monoclonal Antibody Therapy in Kidney Transplant Recipients With Delta and Omicron Variants of SARS-CoV-2: A Single-Center Case Series
Spike protein Spike variant Protein factor Antibody Cohort study
Kidney transplant recipients

The monoclonal antibody displayed efficacy in kidney transplant recipients with a moderate SARS-CoV-2 infection (including the Omicron variant). Casirivimab was combined with imdevimab. Sample size: 47. Dosage: Casirivimab at 1,200u2005mg and imdevimab at 1,200u2005mg administered as an intravenous infusion. 

Aug/26/2022
De novo emergence of a remdesivir resistance mutation during treatment of persistent SARS-CoV-2 infection in an immunocompromised patient: a case
Spike protein Spike variant Protein factor In vitro Antibody
Vero E6 kidney epithelial cells

Monoclonal antibodies (combination of casirivimab and imdevimab) can provide advantages for immunocompromised patient and exhibit consistent positive outcomes. 

Mar/17/2022
Coronavirus Disease 2019 Positivity Immediately After Lung Transplantation: A Case Report
Spike protein Protein factor Case report Antibody
Lung transplant recipient positive for COVID-19 the day after transplant

Treatment (remdesivir with monoclonal antibodies - casirivimab in combination with imdevimab) was effective in a lung transplant recipient. Sample size: 1. Dosage: 600 mg/600 mg casirivimab/imdevimab on postoperative day 1. 

Apr/22/2022
First Case of COVID-19 Treated with Monoclonal Anti-Spike Antibodies in a Patient with Cystic Fibrosis in Romania
Spike protein Protein factor Case report Antibody
17-year-old male adolescent with cystic fibrosis and multiple chronic conditions

This is the initial documentation of administering monoclonal antibodies to a patient with cystic fibrosis, which was well-tolerated and resulted in positive clinical outcomes.  Casirivimab was combined with imdevimab. Sample size: 1. Dosage: Casirivimab 1200 mg and imdevimab 1200 mg as a single 1-h intravenous infusion. 

Jan/07/2022
Successful early use of anti-SARS-CoV-2 monoclonal neutralizing antibodies in SARS-CoV-2 infected hematological patients – A Czech multicenter experience
Spike protein Severe severity Asymptomatic Protein factor Critical severity Antibody Moderate severity Mild severity Cohort study
Hematological patients with lymphomas, acute leukemias and myeloma

Early initiation of treatment with monoclonal antibodies against the SARS-CoV-2 spike protein is effective and improves prognosis among hematological patients. The mortality of patients with COVID-19 was 3 times lower compared to the control group. Sample size: 88 +  575 control. Dosage: Single dose of 1200 mg of casirivimab/1200 mg of imdevimab. 

Feb/17/2022
Successful early use of anti-SARS-CoV-2 monoclonal neutralizing antibodies in SARS-CoV-2 infected hematological patients – A Czech multicenter experience
Spike protein Spike variant Severe severity Asymptomatic Protein factor Critical severity Antibody Moderate severity Mild severity Cohort study
Hematological patients with lymphomas, acute leukemias and myeloma

Early initiation of treatment with monoclonal antibodies against the SARS-CoV-2 spike protein is effective and improves prognosis among hematological patients. The mortality of patients with COVID-19 was 3 times lower compared to the control group. Sample size: 88 +  575 control. Dosage: Single dose of 1200 mg of casirivimab/1200 mg of imdevimab. 

Feb/17/2022
Coronavirus Disease 2019 Positivity Immediately After Lung Transplantation: A Case Report
Spike protein Protein factor Case report Antibody
Lung transplant recipient positive for COVID-19 the day after transplant

Treatment (remdesivir with monoclonal antibodies - casirivimab in combination with imdevimab) was effective in a lung transplant recipient. Sample size: 1. Dosage: 600 mg/600 mg casirivimab/imdevimab on postoperative day 1. 

Apr/22/2022
Clinical efficacy and in vitro neutralization capacity of monoclonal antibodies for severe acute respiratory syndrome coronavirus 2 delta and omicron variants
Spike protein Spike variant Protein factor In vitro Antibody Cohort study
Patients; Vero cells (ATCC CRL-1008)

Treatment with casivirimab/imdevimab was effective in patients with the Delta variant. Casirivimab was combined with imdevimab. Sample size: 25. 

Jun/03/2022
Casirivimab - Imdevimab in Covid 19 – Early Indian experience
Spike protein Protein factor Antibody Cohort study
Patients

In Indian patients, the use of a monoclonal antibody combination for COVID-19 has been found to be both effective and safe. Casirivimab was combined with imdevimab. Sample size: 29. 

Oct/04/2021
Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19
Spike protein Protein factor Phase III clinical trial Phase II clinical trial Phase I clinical trial Randomized controlled double-blind trial Antibody
Patients on low-flow or no supplemental oxygen were treated

Monoclonal antibody treatment efficacious in hospitalized patients with a susceptible SARS-CoV-2 variant in a randomized, open-label, placebo-controlled trial. Casirivimab was administered either by itself or together with imdevimab. Sample size: 804 + 393 placebo. Dosage: Single intravenous dose of 2.4 g casirivimab + imdevimab (1.2 g of each component) or 8.0 g casirivimab + imdevimab (4.0 g of each component). 

Jul/27/2022
Treatment of COVID-19 with monoclonal antibodies casirivimab and imdevimab in pregnancy
Spike protein Protein factor Case series Antibody
Unvaccinated pregnant patients

Administering monoclonal antibodies as a treatment to pregnant patients suffering from COVID-19 has had positive effects. Casirivimab was combined with imdevimab. Sample size: 7. Dosage: Infusion of either 600 mg or 1200 mg of casirivimab–imdevimab. Main outcome: A time-dependent viral load statistics (virological) and mortality (dependent on defined parameters) (clinical).

Apr/28/2022
Monoclonal Antibodies Casirivimab and Imdevimab in Pregnancy for Coronavirus Disease 2019 (COVID-19)
Spike protein Protein factor Case report Antibody
Unvaccinated pregnant individuals

Monoclonal antibodies approved under an emergency use authorization, should be considered in unvaccinated pregnant individuals with mild-to-moderate COVID-19 to decrease the risk of severe disease. Casirivimab was combined with imdevimab. Sample size: 2. Dosage:  600 mg (casirivimab + imdevimab) IV. 

Dec/01/2021
Vaccinated patients have reduced rates of hospitalization after receiving casirivimab and imdevimab for COVID-19
Spike protein Outpatients Protein factor Antibody Cohort study
Outpatients

After receiving casirivimab/imdevimab treatment for COVID-19, individuals who have been vaccinated have lower rates of hospitalization compared to those who have not received the vaccine.  Sample size: 198 (fully vaccinated)+ 55(partially vaccinated)+ 969 (unvaccinated). 

Jun/01/2022
Casirivimab-imdevimab for Treatment of COVID-19 in Solid Organ Transplant Recipients: An Early Experience
Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study
Solid organ transplant recipients

Among the individuals who received treatment with casirivimab-imdevimab and had mild to moderate COVID-19, there were no cases of worsening symptoms or hospitalization due to COVID-19. Sample size: 25. 

Jul/01/2021
Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving monoclonal antibodies
Spike protein Spike variant Protein factor In vitro Antibody Cohort study
Immunocompromised individuals; Vero E6 cells; S-Fuse cells

The combination of casivimab and imdevimab ("Ronapreve" formulation) retained greater neutralizing activity against the Delata variant and lower neutralizing activity against the Omicron variant. Sample size: 29. 

Mar/23/2022
Breakthrough COVID-19 and casirivimab-imdevimab treatment during a SARS-CoV-2 B1.617.2 (Delta) surge
Spike protein Protein factor Antibody Cohort study
Patients

Both the vaccinated and unvaccinated cohorts who received casirivimab-imdevimab treatment had lower rates of hospitalization compared to those who did not receive the treatment. Sample size: 112 + 291 control. Main outcome: The proportion of individuals who require hospitalization within 28 days of being diagnosed with COVID-19.

Dec/01/2021
The effect of casirivimab with imdevimab on disease progression in nonsevere COVID-19 patients in a single hospital in Japan
Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study
Japanese patients

The combination of casirivimab and imdevimab has been found to significantly decrease the progression of the disease in early-stage COVID-19 patients in Japan who have a fever and are at risk of developing severe symptoms. Sample size: 128. Dosage: 600 mg casirivimab with 600 mg imdevimab 600 mg intravenously. Main outcome: Progression to severe COVID-19.

Dec/19/2021
Efficacy of Bamlanivimab/Etesevimab and Casirivimab/Imdevimab in Preventing Progression to Severe COVID-19 and Role of Variants of Concern
Spike protein Spike variant Protein factor Antibody Moderate severity Mild severity Cohort study
High-risk outpatients

Patients who were infected with the Gamma variant and treated with bamlanivimab/etesevimab had a greater likelihood of being hospitalized or dying than those who were given casirivimab/imdevimab. Sample size: 165. Dosage: Casirivimab (1200 mg) combined with imdevimab (1200 mg). Main outcome: Need for hospitalization related to COVID-19 or death from any cause by day 30.

Aug/25/2021
Association of Subcutaneous or Intravenous Administration of Casirivimab and Imdevimab Monoclonal Antibodies With Clinical Outcomes in Adults With COVID-19
Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study
High-risk outpatients

Administrated casirivimab/imdevimab via subcutaneous injection was linked to a reduced likelihood of hospitalization or death when compared to not receiving these monoclonal antibody treatments. Furthermore, no significant difference was observed in the risk of death, ICU admission, or need for mechanical ventilation within 28 days between patients who received the antibodies via subcutaneous injection versus those who received them intravenously. Sample size: 969 (subcutaneous) + 1216 (intravenous) + 4353 control. Dosage: Subcutaneous injection or intravenous administration of the combined single dose of 600 mg of casirivimab and 600 mg of imdevimab. Main outcome: Hospitalization or all-cause death through day 28.

Apr/12/2022
Effects of Casirivimab/Imdevimab Monoclonal Antibody Treatment among Vaccinated Patients Infected by SARS-CoV-2 Delta Variant
Spike protein Protein factor Case series Antibody
Symptomatic non-hospitalized vaccinated patients

The use of mAbs as a treatment appears to be both safe and effective in addressing the clinical symptoms of the Delta variant. Sample size: 5. Dosage: Casirivimab (1200 mg) and imdevimab (1200 mg)  IV. 

Mar/21/2022
Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Spike protein Protein factor Randomized controlled open trial Antibody
Hospitalized patients

Monoclonal antibody treatment for COVID-19 can lower the risk of death in patients who are hospitalized. Sample size: 4 839 + 4 946 control. Dosage: Casirivimab 4 g and imdevimab 4 g in a single intravenous infusion. Main outcome: Assessment of 28-day all-cause mortality using treatment-directed analysis, first in patients without detectable antibodies to SARS-CoV-2 and then in the whole population.

Feb/12/2022
Combination Therapy With Casirivimab/Imdevimab and Remdesivir for Protracted SARS-CoV-2 Infection in B-cell-Depleted Patients
Spike protein Protein factor Case series Antibody
B-cell-depleted patients

The use of monoclonal antibodies and off-label remdesivir in COVID-19 patients with depleted B cells and prolonged infection proved to be effective and well-tolerated. Sample size: 3. Dosage: A single dose of 1,200 mg casirivimab and imdevimab IV and a 5-day course of remdesivir 200 mg IV, then 100 mg daily. 

May/26/2022
Biophysical Fitness Landscape of the SARS-CoV-2 Delta Variant Receptor Binding Domain
Spike protein Spike variant Protein factor In vitro Antibody
Expi293 HEK cells

Due to its insensitivity to mutations carried by the delta spike, casirivimab is able to neutralize the Delta variant. 

Jul/15/2022
The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study 
Spike protein Outpatients Protein factor Antibody Cohort study
Outpatients

Patients with COVID-19 who received monoclonal antibody treatment while being treated as outpatients were considerably less prone to being admitted to the hospital or visiting the emergency department than those who did not receive mAbs. Casirivimab was combined with imdevimab. Sample size: 1344 + 9009 control. 

Oct/15/2022

AI-suggested references

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Monoclonal Antibodies Receive EUA to Treat Mild to Moderate COVID-19.
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Characterization and antiviral susceptibility of SARS-CoV-2 Omicron/BA.2.
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Casirivimab-imdevimab neutralizing SARS-CoV-2: post-infusion clinical events and their risk factors.
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Cost-effectiveness of casirivimab/imdevimab in patients with COVID-19 in the ambulatory setting.
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Preclinical discovery and development of the casirivimab + imdevimab cocktail for the treatment of novel coronavirus infection: the rise and fall.
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Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial.
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Comprehensive Treatment of Hematological Patients with SARS-CoV-2 Infection Including Anti-SARS-CoV-2 Monoclonal Antibodies: A Single-Center Experience Case Series
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Effectiveness of casirivimab/imdevimab in an intensive care unit patient with acute respiratory failure due to SARS-CoV-2 infection.
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Editorial: Post-Exposure Prophylactic Neutralizing Monoclonal Antibodies to SARS-CoV-2 for Individuals at High Risk for COVID-19
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SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
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Real-world Assessment of 2879 COVID-19 Patients Treated With Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study
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High titer of antibody against the SARS-CoV-2 spike protein among patients receiving neutralizing antibody cocktail therapy with REGN-COV
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Effect of monoclonal antibody therapy on the endogenous SARS-CoV-2 antibody response
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Neutralizing Monoclonal Antibody Treatment Reduces Hospitalization for Mild and Moderate COVID-19: A Real-World Experience
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Perspectives on passive antibody therapy and peptide-based vaccines against emerging pathogens like SARS-CoV-2.
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Impact of New Variants on SARS-CoV-2 Infectivity and Neutralization: A Molecular Assessment of the Alterations in the Spike-Host Protein Interactions
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Successful Treatment of Persistent Coronavirus Disease 2019 Infection in a Patient With Hypogammaglobulinemia With REGN-COV2: A Case Report.
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An update of antispike severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies
Mar/29/2022
Real-World Clinical Outcomes of Bamlanivimab and Casirivimab-Imdevimab among High-Risk Patients with Mild to Moderate Coronavirus Disease 2019
Jul/20/2021
Casirivimab/Imdevimab: First Approval
Oct/31/2021
Neutralizing Antibody Therapeutics for COVID-19.
Apr/07/2021
SARS-CoV-2 Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Kidney Transplant Recipients.
Oct/20/2021
In-Silico Analysis of Monoclonal Antibodies against SARS-CoV-2 Omicron
Feb/14/2022
Compassionate Use of REGEN-COV in Patients with COVID-19 and Immunodeficiency-Associated Antibody Disorders
Jan/01/2022
Omicron's binding to sotrovimab, casirivimab, imdevimab, CR3022, and sera from previously infected or vaccinated individuals
Mar/14/2022
Casirivimab-Imdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19.
Aug/30/2021
Case Report of COVID-19 Infection After Kidney Transplant Treated With Casirivimab-Imdevimab and Mycophenolate Mofetil Changed to Everolimus.
Dec/31/2021
Influence of treatment with neutralizing monoclonal antibodies on the SARS-CoV-2 nasopharyngeal load and quasispecies
Jun/13/2020
Successful early use of anti-SARS-CoV-2 monoclonal neutralizing antibodies in SARS-CoV-2 infected hematological patients - A Czech multicenter experience
Feb/17/2022
Thermodynamic and structural insights into the repurposing of drugs that bind to SARS-CoV-2 main protease
Nov/18/2021
Melatonin and REGN-CoV2 combination as a vaccine adjuvant for Omicron variant of SARS-CoV-2
Sep/07/2021
Persistent SARS-CoV-2 infection in patients with secondary antibody deficiency: successful clearance following combination casirivimab and imdevimab (REGN-COV2) monoclonal antibody therapy
Dec/30/2021
Limited neutralization of authentic SARS-CoV-2 variants carrying E484K in vitro
Jun/07/2021
A Comparison of SARS-COV-2 Neutralizing Antibody Therapies in High-Risk Patients with Mild to Moderate COVID-19 Disease at a Single Academic Hospital.
Jul/15/2021
Comparative Efficacy of Early COVID-19 Monoclonal Antibody Therapies: A Retrospective Analysis
Apr/20/2022
Neutralizing antibodies against SARS-CoV-2: current understanding, challenge and perspective.
Dec/28/2021

Clinical trials

ID Title Status Phase Start date Completion date
NCT05268601 COVID-19 and Disease Progression to the Severe Form: A Study on the Use of Monoclonal Antibodies Against SARS-CoV-2 Recruiting Oct/14/2021 May/31/2024
  • Alternative id - MABCOVID01
  • Interventions - Drug: Bamlanivimab|Drug: Bamlanivimab and Etesevimab Drug Combination|Drug: Casirivimab and Imdevimab Drug Combination|Drug: Sotrovimab
  • Study type - Observational
  • Study results - No Results Available
  • Locations - Asst-Monza Ospedale San Gerardo, Monza, Lombardia, Italy
  • Study designs - Observational Model: Cohort|Time Perspective: Other
  • Enrollment - 1000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Estimating the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies up to 30 days|Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.|Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days|Identifying possible predictive factors of hospitalisation|Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days
NCT05092581 COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19 Active, not recruiting Phase 1 Dec/16/2021 Jun/15/2022
  • Alternative id - R10933-10987-COV-2114|2021-004535-84
  • Interventions - Drug: casirivimab+imdevimab
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - State University of New York at Stony Brook, Stony Brook, New York, United States|Le Bonheur Children's Hospital, Memphis, Tennessee, United States
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 2
  • Age - up to 17 Years   (Child)
  • Outcome measures - Concentrations of casirivimab+imdevimab in serum over time|Proportion of patients with treatment-emergent serious adverse events (SAEs)|Proportion of patients with infusion-related reactions|Proportion of patients with hypersensitivity reactions|Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time|Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time
NCT04425629 Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19 Active, not recruiting Phase 3 Jun/16/2020 Jun/09/2022
  • Alternative id - R10933-10987-COV-2067|2020-003690-21
  • Interventions - Drug: casirivimab+imdevimab combination therapy
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Study Site, Mesa, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Canoga Park, California, United States|Regeneron Study Site, La Mesa, California, United States|Regeneron Study Site, La Palma, California, United States|Regeneron Study Site 1, Long Beach, California, United States|Regeneron Study Site 2, Long Beach, California, United States|Regeneron Study Site 3, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Montclair, California, United States|Regeneron Study Site, Rolling Hills Estates, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, San Francisco, California, United States|Regeneron Study Site, Santa Monica, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Aurora, Colorado, United States|Regeneron Study Site, Colorado Springs, Colorado, United States|Regeneron Study Site, Washington, District of Columbia, United States|Regeneron Study Site, Boca Raton, Florida, United States|Regeneron Study Site, DeLand, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Loxahatchee Groves, Florida, United States|Regeneron Study Site, Maitland, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site 1, Miami, Florida, United States|Regeneron Study Site 2, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Saint Petersburg, Florida, United States|Regeneron Study Site, Sarasota, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, West Palm Beach, Florida, United States|Regeneron Study Site, Winter Haven, Florida, United States|Regeneron Study Site, Winter Park, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Augusta, Georgia, United States|Regeneron Study Site, Columbus, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site 1, Downers Grove, Illinois, United States|Regeneron Study Site 2, Downers Grove, Illinois, United States|Regeneron Study Site, Downers Grove, Illinois, United States|Regeneron Study Site, Ames, Iowa, United States|Regeneron Study Site, Iowa City, Iowa, United States|Regeneron Study Site, Lake Charles, Louisiana, United States|Regeneron Study Site, Marrero, Louisiana, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, Shreveport, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Royal Oak, Michigan, United States|Regeneron Study Site, Jackson, Mississippi, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Ridgewood, New Jersey, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site, Santa Fe, New Mexico, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Jamaica, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Charlotte, North Carolina, United States|Regeneron Study Site, Durham, North Carolina, United States|Regeneron Study Site, Wilmington, North Carolina, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Clinton, South Carolina, United States|Regeneron Study Site, Sioux Falls, South Dakota, United States|Regeneron Study Site 2, Memphis, Tennessee, United States|Regeneron Study Site, Memphis, Tennessee, United States|Regeneron Study Site, Amarillo, Texas, United States|Regeneron Study Site, Corpus Christi, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Pearland, Texas, United States|Regeneron Study Site, Red Oak, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Falls Church, Virginia, United States|Regeneron Study Site, Everett, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Regeneron Study Site, Madison, Wisconsin, United States|Regeneron Study Site, Guadalajara, Jalisco, Mexico|Regeneron Study Site, Guadalajara, Jalisco, Mexico|Regeneron Study Site, Zapopan, Jalisco, Mexico|Regeneron Study Site, Monterrey, Nuevo Leon, Mexico|Regeneron Study Site, Monterrey, Nuevo León, Mexico|Regeneron Study Site, Merida, Yucatan, Mexico|Regeneron Study Site, Chihuahua, Mexico|Regeneron Study Site, Ciudad de Mexico, Mexico|Regeneron Study Site, Durango, Mexico|Regeneron Study Site, Mérida, Mexico|Regeneron Study Site, Veracruz, Mexico|Regeneron Study Site, Bucuresti, Romania
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 10078
  • Age - Child, Adult, Older Adult
  • Outcome measures - Proportion of patients with treatment-emergent serious adverse events (SAEs)|Proportion of patients with infusion-related reactions|Proportion of patients with hypersensitivity reactions|Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples|Proportion of patients with at least one (≥1) COVID-19-related hospitalization or all-cause death|Concentration of REGN10933 in serum over time|Concentration of REGN10987 in serum over time|Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in saliva samples|Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in nasal swab samples|Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples|Time to negative RT-qPCR in nasopharyngeal swabs with no subsequent positive RT-qPCR|Change from baseline in viral load at each visit, as measured by RT-qPCR in nasopharyngeal swabs|Change from baseline in viral load at each visit, as measured by RT-qPCR in saliva samples|Change from baseline in viral load at each visit, as measured by RT-qPCR in nasal swabs|Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva)|Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva)|Time-weighted average change from baseline in viral load (log10 copies/mL) from day 1 to post-baseline study days|Proportion of participants with ≥1 COVID-19-related medically-attended visit|Proportion of participants with ≥2 COVID-19-related medically-attended visit|Total number of COVID-19-related medically-attended visits|Proportion of participants admitted to a hospital due to COVID-19|Proportion of participants with ≥1 outpatient or telemedicine visit due to COVID-19|Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933|Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987|Assessment of PK parameter: Time to Cmax (tmax) for REGN10933|Assessment of PK parameter: Time to Cmax (tmax) for REGN10987|Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933|Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987|Immunogenicity as measured by anti-drug (ADA) to REGN10933|Immunogenicity as measured by ADA to REGN10987|Immunogenicity as measured by neutralizing antibodies (NAbs) to REGN10933|Immunogenicity as measured by NAbs to REGN10987|Proportion of participants with high viral load at each visit|Proportion of participants with viral loads below the limit of detection at each visit|Proportion of participants with viral loads below the lower limit of quantitation at each visit|Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19|Proportion of participants requiring mechanical ventilation due to COVID-19|Number of days of hospitalization due to COVID-19|Proportion of participants with all-cause mortality|Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only)|Duration of symptoms consistent with COVID-19|Proportion of participants with ≥1 COVID-19-related hospitalization or all-cause death|Time to COVID-19 symptoms resolution|Proportion of participants with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death|Proportion of patients with (≥1) COVID-19-related medically-attended visit or all-cause death|Proportion of participants with ≥1 COVID-19-related medically-attended visit by type of visit|Cumulative incidence of patients with ≥1 COVID-19-related hospitalization or all-cause death|Cumulative incidence of patients with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death|Cumulative incidence of patients with ≥1 COVID-19-related medically-attended visit or all-cause death|Proportion of participants requiring supplemental oxygen due to COVID-19|Time to all-cause death|All-cause death
NCT04790786 UPMC OPTIMISE-C19 Trial, a COVID-19 Study Recruiting Phase 3 Mar/10/2021 Dec/01/2023
  • Alternative id - STUDY21020179
  • Interventions - Biological: Lilly Bamlanivimab|Biological: Regeneron Casirivimab + Imdevimab|Biological: Lilly Bamlanivimab + Etesevimab|Biological: Sotrovimab
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - UPMC, Pittsburgh, Pennsylvania, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other
  • Enrollment - 30000
  • Age - 12 Years to 120 Years   (Child, Adult, Older Adult)
  • Outcome measures - Alive and Free from Hospitalization|All-location mortality at 90 days|All-location mortality at 28 days|All-cause mortality at 28 days|All-cause mortality at 90 days|Organ-support free days at day 28|SARS-CoV-2 nasopharyngeal viral loads|SARS-CoV-2 plasma viral loads|SARS-CoV-2 antibody titers|SARS-CoV-2 antibody neutralization|SARS-CoV-2 immune responses|Detection of SARS-CoV-2 variants through next-generation sequencing|Duration of SAR-CoV-2 infectivity|Non-culture surrogates for SARS-CoV-2 infectivity
NCT04426695 Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 Completed Phase 1|Phase 2 Jun/11/2020 Oct/22/2021
  • Alternative id - R10933-10987-COV-2066|2020-002537-15
  • Interventions - Drug: REGN10933+REGN10987 combination therapy|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Study Site, Birmingham, Alabama, United States|Regeneron Study Site, Chandler, Arizona, United States|Regeneron Study Site, Phoenix, Arizona, United States|Regeneron Study Site 1, Tucson, Arizona, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Mission Hills, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, Santa Monica, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Aurora, Colorado, United States|Regeneron Study Site, Boca Raton, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Gainesville, Florida, United States|Regeneron Study Site, Orlando, Florida, United States|Regeneron Study Site, Pensacola, Florida, United States|Regeneron Study Site, Sarasota, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Augusta, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site, Glenview, Illinois, United States|Regeneron Study Site, Urbana, Illinois, United States|Regeneron Study Site, Indianapolis, Indiana, United States|Regeneron Study Site, Iowa City, Iowa, United States|Regeneron Study Site, Louisville, Kentucky, United States|Regeneron Study Site, Louisville, Kentucky, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Grand Rapids, Michigan, United States|Regeneron Study Site, Royal Oak, Michigan, United States|Regeneron Study Site, Rochester, Minnesota, United States|Regeneron Study Site, Chesterfield, Missouri, United States|Regeneron Study Site, Saint Louis, Missouri, United States|Regeneron Study Site, Saint Louis, Missouri, United States|Regeneron Study Site, Omaha, Nebraska, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Englewood, New Jersey, United States|Regeneron Study Site, Hackensack, New Jersey, United States|Regeneron Study Site, Morristown, New Jersey, United States|Regeneron Study Site, Neptune, New Jersey, United States|Regeneron Study Site, Pennington, New Jersey, United States|Regeneron Study Site, Summit, New Jersey, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site, Albuquerque, New Mexico, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Brooklyn, New York, United States|Regeneron Study Site, Buffalo, New York, United States|Regeneron Study Site 1, Buffalo, New York, United States|Regeneron Study Site 2, Buffalo, New York, United States|Regeneron Study Site, Jamaica, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Rochester, New York, United States|Regeneron Study Site, Syracuse, New York, United States|Regeneron Study Site, West Islip, New York, United States|Regeneron Study Site, White Plains, New York, United States|Regeneron Study Site, Chapel Hill, North Carolina, United States|Regeneron Study Site, Greensboro, North Carolina, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Portland, Oregon, United States|Regeneron Study Site, Portland, Oregon, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Sioux Falls, South Dakota, United States|Regeneron Study Site 1, Amarillo, Texas, United States|Regeneron Study Site 2, Amarillo, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Lubbock, Texas, United States|Regeneron Study Site, Sugar Land, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Murray, Utah, United States|Regeneron Study Site, Salt Lake City, Utah, United States|Regeneron Study Site, Richmond, Virginia, United States|Regeneron Study Site, Everett, Washington, United States|Regeneron Study Site 1, Seattle, Washington, United States|Regeneron Study Site, Madison, Wisconsin, United States|Regeneron Study Site, Salvador, Bahia, Brazil|Regeneron Study Site, Fortaleza, Ceara, Brazil|Regeneron Study Site, Curitiba, Paraná, Brazil|Regeneron Study Site, Porto Alegre, Rio Grande Do Sul, Brazil|Regeneron Study Site, Passo Fundo, RS, Brazil|Regeneron Study Site, Chapeco, Santa Catarina, Brazil|Regeneron Study Site, Criciuma, Santa Catarina, Brazil|Regeneron Study Site, Botucatu, Sao Paolo, Brazil|Regeneron Study Site, Campinas, Sao Paolo, Brazil|Regeneron Study Site, São Paulo, Brazil|Regeneron Study Site, São Paulo, Brazil|Regeneron Study Site, São Paulo, Brazil|Regeneron Study Site 1, Las Condes, Santiago De Chile, Chile|Regeneron Study Site 2, Las Condes, Santiago De Chile, Chile|Regeneron Study Site, Vitacura, Santiago De Chile, Chile|Regeneron Study Site, Santiago de Chile, Chile|Regeneron Study Site, Guadalajara, Jalisco, Mexico|Regeneron Study Site, Monterrey, Nuevo Leon, Mexico|Regeneron Study Site, Culiacán, Sinaloa, Mexico|Regeneron Study Site, Culiacan, Mexico|Regeneron Study Site, Monterrey, Mexico|Regeneron Study Site 1, Mérida, Mexico|Regeneron Study Site 2, Mérida, Mexico|Regeneron Study Site, Veracruz, Mexico|Regeneron Study Site, Zapopan, Mexico|Regeneron Study Site, Chisinau, Moldova, Republic of|Regeneron Study Site, Bucuresti, Romania
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 2252
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Time-weighted average change from baseline in viral load as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples|Proportion of patients who died or required mechanical ventilation|Incidence of patients who died or required mechanical ventilation|Proportion of patients with treatment-emergent Serious Adverse Events (SAEs)|Proportion of patients with infusion-related reactions|Proportion of patients with hypersensitivity reactions|Proportion of patients who required mechanical ventilation|Proportion of patients who died|Proportion of patients who were discharged|Proportion of patients who died or were readmitted to hospital over time|Cumulative incidence of death over time|Cumulative incidence of mechanical ventilation over time|Cumulative incidence of death or mechanical ventilation over time|Time to discharge|Time-weighted average change from baseline in viral load as measured by RT-qPCR in NP swab samples|Change from baseline in viral load as measured by RT-qPCR in NP swabs|Percent change from baseline in viral load as measured by RT-qPCR in NP swabs|Time to sustained negative RT-qPCR in NP swab samples|Serum concentration of REGN10933 over time|Serum concentration of REGN10987 over time|Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933|Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933|Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987|Assessment of PK parameter: Time to Cmax (tmax) for REGN10933|Assessment of PK parameter: Time to Cmax (tmax) for REGN10987|Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933|Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987|Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933|Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10987|Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933|Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987|Assessment of PK parameter: Observed terminal half-life [t1/2] for REGN10933|Assessment of PK parameter: Observed terminal half-life [t1/2] of REGN10987|Assessment of PK parameter: Clearance (CL) for REGN10933|Assessment of PK parameter: Clearance (CL) of REGN10987|Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10933|Assessment of PK parameter: Volume of distribution at steady state (Vss) of REGN10987|Assessment of PK parameter: Mean residence time (MRT) of REGN10933|Assessment of PK parameter: Mean residence time (MRT) of REGN10987|Incidence of anti-drug antibodies (ADA) to REGN10933|Incidence of anti-drug antibodies (ADA) to REGN10987|Incidence of neutralizing antibodies (NAbs) to REGN10933|Incidence of neutralizing antibodies (NAbs) to REGN10987
NCT05149300 COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age Recruiting Phase 2 Sep/13/2021 Nov/17/2022
  • Alternative id - R10933-10987-COV-2121|2021-004590-30
  • Interventions - Drug: casirivimab+imdevimab
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Advanced Research Center, Inc, Anaheim, California, United States|Batchelor's Children's Research Institute, Miami, Florida, United States|Jacobi Medical Center, Bronx, New York, United States|Stony Brook University Hospital, Stony Brook, New York, United States|Coastal Pediatric Research, Charleston, South Carolina, United States|Regeneron Research Site, Richmond, Virginia, United States
  • Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 28
  • Age - up to 12 Years   (Child)
  • Outcome measures - Concentrations of casirivimab+imdevimab in serum over time.|Number of participants with treatment-emergent adverse events (TEAEs)|Severity of TEAEs|Number of participants with grade ≥3 injection site reactions|Number of participants with grade ≥3 hypersensitivity reactions|Immunogenicity as measured by anti-drug antibodies (ADA) to casirivimab over time|Immunogenicity as measured by ADA to imdevimab over time|Immunogenicity as measured by neutralizing antibodies (NAb) to casirivimab over time|Immunogenicity as measured by NAb to imdevimab over time
NCT04518410 ACTIV-2: A Study for Outpatients With COVID-19 Recruiting Phase 2|Phase 3 Aug/19/2020 Dec/31/2023
  • Alternative id - A5401/ACTIV-2|38742
  • Interventions - Biological: bamlanivimab|Drug: Placebo (IV)|Biological: BRII-196/BRII-198|Biological: AZD7442 (IV)|Biological: AZD7442 (IM)|Drug: SNG001|Drug: Camostat|Drug: Placebo (IM)|Drug: Placebo (Inhaled solution)|Drug: Placebo (oral tablet)|Biological: BMS-986414 + BMS-986413|Drug: Placebo (SC injections)|Biological: SAB-185 (3,840 Units/kg)|Biological: SAB-185 (10,240 Units/kg)|Drug: CASIRIVIMAB + IMDEVIMAB
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Pinnacle Research Group (Site 1082), 321 E. 10th Street, Anniston, Alabama, United States|North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B, Athens, Alabama, United States|University of Alabama at Birmingham (Site 1005), 908 20th Street South, Birmingham, Alabama, United States|Cullman Clinical Trials (Site 1140), 501 Clark St. NE., Cullman, Alabama, United States|Jasper Summit Research, LLC. (Site 1056), 1280 Summit, Jasper, Alabama, United States|Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211, Phoenix, Arizona, United States|University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410, Tucson, Arizona, United States|Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I, Anaheim, California, United States|Franco A. Felizarta MD (Site 1174), 3535 San Dimas St., Bakersfield, California, United States|Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103, Canyon Country, California, United States|St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd., Fullerton, California, United States|University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer, La Jolla, California, United States|Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320, La Mesa, California, United States|Atella Clinical Research (Site 1111), 5451 La Palma Avenue, La Palma, California, United States|Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C, Loma Linda, California, United States|University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349, Los Angeles, California, United States|UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100, Los Angeles, California, United States|Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100, Los Angeles, California, United States|VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way, Mather, California, United States|Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5, Modesto, California, United States|Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr., Newport Beach, California, United States|Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210, Northridge, California, United States|University of California Irvine (Site 1083), 843 Health Sciences Road, Orange, California, United States|FOMAT Medical Research (Site 1136), 300 South A Street, Oxnard, California, United States|Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive, Rancho Mirage, California, United States|Paradigm Research (Site 1150), 3652 Eureka Way, Redding, California, United States|Riverside Medical Clinic (Site 1232), 7117 Brockton Ave., Riverside, California, United States|University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd., Sacramento, California, United States|Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave., San Bernardino, California, United States|University of California San Diego (Site 1002), 220 Dickinson Street, San Diego, California, United States|Zion Medical Center (Site 1063), 4647 Zion Avenue, San Diego, California, United States|VA San Diego Health System (Stie 1127), 3350 La Jolla, San Diego, California, United States|University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84, San Francisco, California, United States|San Francisco Research Institute (Site 1210), 2435 Ocean Ave., San Francisco, California, United States|Stanford University (Site 1213), 1201 Welch Road, Stanford, California, United States|Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208, Thousand Oaks, California, United States|Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301, Thousand Oaks, California, United States|Harbor UCLA (Site 1022), 1124 West Carson Street, Torrance, California, United States|Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101, Westminster, California, United States|University of Colorado (Site 1007), 12401 East 17th Avenue, Aurora, Colorado, United States|UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248, Storrs, Connecticut, United States|Whitman-Walker Health (Site 1027), 1337 R Street NW., Washington, District of Columbia, United States|Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2, Boynton Beach, Florida, United States|Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W, Bradenton, Florida, United States|Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350, Bradenton, Florida, United States|Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301, Daytona Beach, Florida, United States|Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive, DeLand, Florida, United States|Integrity Clinical Research (Site 1214), 3901 NW 79th Ave., Doral, Florida, United States|Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave., Doral, Florida, United States|EMINAT Research (Site 1202), 2500 E. Commercial Blvd., Fort Lauderdale, Florida, United States|Holy Cross Health (Site 1072), 4725 North Federal Highway, Fort Lauderdale, Florida, United States|North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd., Gainesville, Florida, United States|University of Florida (Site 1047), 1600 SW. Archer Rd., Gainesville, Florida, United States|NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway, Gulf Breeze, Florida, United States|Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300, Hialeah, Florida, United States|AGA Clinical Trials (Site 1026), 900 West 49th Street, Hialeah, Florida, United States|Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403, Hialeah, Florida, United States|New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106, Hialeah, Florida, United States|Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403, Hialeah, Florida, United States|Innovative Health Medical Center (Site 1222), 6750 Taft Street, Hollywood, Florida, United States|University of Florida Jacksonville (Site 1039), 655 West 8th Street, Jacksonville, Florida, United States|Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S., Jacksonville, Florida, United States|QC Trials (Site 1117), 300 W. 41st Street, Ste. 203, Miami Beach, Florida, United States|Lakes Research (Site 1037), 5801 NW 151 Street, Miami Lakes, Florida, United States|Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street, Miami Lakes, Florida, United States|Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue, Miami Shores, Florida, United States|Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street, Miami, Florida, United States|Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave., Miami, Florida, United States|Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701, Miami, Florida, United States|University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave., Miami, Florida, United States|Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103, Miami, Florida, United States|D&H National Research Centers (Site 1205), 8485 Bird Road, Miami, Florida, United States|Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220, Miami, Florida, United States|Miami Clinical Research (Site 1089), 2400 SW. 69th Ave., Miami, Florida, United States|Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201, Miami, Florida, United States|RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St., Miami, Florida, United States|Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street, Miami, Florida, United States|Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct., Miami, Florida, United States|Bravo Health Care Center (Site 1221), 1440 79 Street, North Bay Village, Florida, United States|Orlando Immunology Center (Site 1045), 1707 North Mills Avenue, Orlando, Florida, United States|Clintheory (Site 1203), 7350 Sandlake Commons Blvd., Orlando, Florida, United States|IMIC, Inc. (Site 1141), 18320 Franjo Rd, Palmetto Bay, Florida, United States|Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102, Pembroke Pines, Florida, United States|Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A, Sarasota, Florida, United States|Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N., Sebring, Florida, United States|DBC Research (Site 1188), 7707 N. University Dr., Ste. 106, Tamarac, Florida, United States|ETNA Medical Center (Site 1225), 7401 N. University Drive, Tamarac, Florida, United States|Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd., Tampa, Florida, United States|Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street, Tampa, Florida, United States|Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201, Vero Beach, Florida, United States|AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place, Vero Beach, Florida, United States|Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4, West Palm Beach, Florida, United States|The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast, Atlanta, Georgia, United States|Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B, Atlanta, Georgia, United States|Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive, Atlanta, Georgia, United States|Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109, Buford, Georgia, United States|IACT Health (Site 1035), 800 Talbotton Road, Columbus, Georgia, United States|Clintheory (Site 1254), 4300 Pleasant Hill Road, Duluth, Georgia, United States|One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160, Norcross, Georgia, United States|Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd., Snellville, Georgia, United States|John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St., Honolulu, Hawaii, United States|Snake River Research, PLLC (Site 1120), 2900 Cortez Ave., Idaho Falls, Idaho, United States|Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201, Burr Ridge, Illinois, United States|Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd., Chicago, Illinois, United States|Northwestern University (Site 1025), 645 North Michigan Ave, Chicago, Illinois, United States|Rush University Medical Center (Site 1017), 600 Paulina St., Chicago, Illinois, United States|University of Illinois at Chicago (Site 1147), 835 South Wood Street, Chicago, Illinois, United States|University of Chicago (Site 1064), 5841 S. Maryland Ave., Chicago, Illinois, United States|Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave., Chicago, Illinois, United States|Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100, Brownsburg, Indiana, United States|Roudebush VA Medical Center (Site 1217), 550 University Blvd, Indianapolis, Indiana, United States|University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard, Kansas City, Kansas, United States|MedPharmics (Site 1065), 3800 Houma Blvd., Metairie, Louisiana, United States|Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street, Monroe, Louisiana, United States|New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904, New Orleans, Louisiana, United States|Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street, New Orleans, Louisiana, United States|Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway, New Orleans, Louisiana, United States|Baltimore VA Medical Center (Site 1258), 10 N. Greene St., Baltimore, Maryland, United States|Johns Hopkins University (Site 1006), 1830 East Monument Street, Baltimore, Maryland, United States|Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave., Silver Spring, Maryland, United States|Massachusetts General Hospital (Site 1016), 55 Fruit Street, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street, Boston, Massachusetts, United States|Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street, Boston, Massachusetts, United States|University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N., Worcester, Massachusetts, United States|Vida Clinical Studies (Site 1244), 3815 Pelham Street, Dearborn, Michigan, United States|Revive Research Institute (Site 1257), 32255 Northwestern Hwy., Farmington Hills, Michigan, United States|Revival Research Corporation (Site 1256), 13409 East 14 Mile Road, Sterling Heights, Michigan, United States|Memorial Hospital at Gulfport (Site 1104), 4500 13th Street, Gulfport, Mississippi, United States|MedPharmics, LLC. (Site 1032), 15190 Community Rd., Gulfport, Mississippi, United States|University of Missouri Health Care System (Site 1224), 1 Hospital Drive, Columbia, Missouri, United States|Hannibal Clinic (Site 1129), 100 Medical Drive, Hannibal, Missouri, United States|Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200, Saint Louis, Missouri, United States|Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103, Bozeman, Montana, United States|Mercury Street Medical Group (Site 1074), 300 W. Mercury St., Butte, Montana, United States|Quality Clinical Research (Site 1112), 10040 Regency Circle, Omaha, Nebraska, United States|Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd., Las Vegas, Nevada, United States|AXCES Research Group (Site 1152), 531 Harkle Road, Santa Fe, New Mexico, United States|Bronx Prevention Research Center (Site 1108), 390 East 158th Street, Bronx, New York, United States|Lincoln Hospital (Site 1092), 249 East 149th Street, Bronx, New York, United States|Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd, Bronx, New York, United States|Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South, Bronx, New York, United States|James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road, Bronx, New York, United States|Maimonides Medical Center (Site 1138), 4802 10th Avenue, Brooklyn, New York, United States|University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street, Buffalo, New York, United States|Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd, Flushing, New York, United States|Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway, Jamaica, New York, United States|Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604, New York, New York, United States|Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street, New York, New York, United States|Canton-Potsdam Hospital (Site 1076), 50 Leroy Street, Potsdam, New York, United States|University of Rochester (Site 1010), 601 Elmwood Ave, Rochester, New York, United States|SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C, Stony Brook, New York, United States|University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor, Chapel Hill, North Carolina, United States|Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd., Charlotte, North Carolina, United States|Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201, Denver, North Carolina, United States|Duke University Medical Center (Site 1041), 40 Duke Medicine Circle, Durham, North Carolina, United States|Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct., Morehead City, North Carolina, United States|Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard, Winston-Salem, North Carolina, United States|Sanford Health (Site 1084), 801 Broadway N., Fargo, North Dakota, United States|The Christ Hospital (Site 1119), 2123 Auburn Avenue, Cincinnati, Ohio, United States|Case Western Reserve University (Site 1033), 2061 Cornell Road, Cleveland, Ohio, United States|MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr., Cleveland, Ohio, United States|Ohio State University Medical Center (Site 1020), 480 Medical Center Drive, Columbus, Ohio, United States|Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way, Ohio City, Ohio, United States|STAT Research (Site 1107), 66 Remick Blvd., Springboro, Ohio, United States|Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street, Tulsa, Oklahoma, United States|Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street, Portland, Oregon, United States|Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave., Portland, Oregon, United States|Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd., Portland, Oregon, United States|Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue, Portland, Oregon, United States|Doylestown Hospital (Site 1122), 595 W. State Street, Doylestown, Pennsylvania, United States|University of Pennsylvania (Site 1031), 3400 Spruce Street, Philadelphia, Pennsylvania, United States|The University of Pittsburgh (Site 1018), 3471 5th Ave., Pittsburgh, Pennsylvania, United States|Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C., Pittsburgh, Pennsylvania, United States|The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue, Providence, Rhode Island, United States|Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2, Columbia, South Carolina, United States|Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D, West Columbia, South Carolina, United States|American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street, Rapid City, South Dakota, United States|Sanford USD Medical Center (Site 1078), 1305 W. 18th St., Sioux Falls, South Dakota, United States|Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive, Franklin, Tennessee, United States|Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183, Nashville, Tennessee, United States|Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560, Bellaire, Texas, United States|South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road, Boerne, Texas, United States|PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd., Brownsville, Texas, United States|Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue, Dallas, Texas, United States|UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court, Dallas, Texas, United States|Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd., Edinburg, Texas, United States|Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive, Galveston, Texas, United States|Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495, Houston, Texas, United States|Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street, Houston, Texas, United States|University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112, Houston, Texas, United States|Houston Methodist Hospital (Site 1123), 6565 Fannin Street, Houston, Texas, United States|Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy, Houston, Texas, United States|Fairway Medical Clinic (Site 1156), 4910 Telephone Road, Houston, Texas, United States|Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100, Humble, Texas, United States|SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave., Mesquite, Texas, United States|Epic Medical Research, LLC (Site 1233), 106 Plaza Drive, Red Oak, Texas, United States|San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr., San Antonio, Texas, United States|Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road, Falls Church, Virginia, United States|Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201, Richmond, Virginia, United States|EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77, Kirkland, Washington, United States|University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave., Seattle, Washington, United States|Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W, Spokane, Washington, United States|Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive, Huntington, West Virginia, United States|West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive, Morgantown, West Virginia, United States|Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue, Milwaukee, Wisconsin, United States|Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road, Milwaukee, Wisconsin, United States|Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200, Wauwatosa, Wisconsin, United States|Instituto Médico Platense (Site 3011), Avenida 51 335, La Plata, Buenos Aires, Argentina|Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240, Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina|Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020, Río Cuarto, Córdoba, Argentina|Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428, Rosario, Santa Fe, Argentina|Clínica Adventista Belgrano (Site 3007), Estomba 1710, Ciudad Autonoma de Buenos Aires, Argentina|Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345, Mar Del Plata, Argentina|Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui, Pilar, Argentina|L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6, Brasília, Distrito Federal, Brazil|Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190, Belo Horizonte, Minas Gerais, Brazil|SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190, Belo Horizonte, Minas Gerais, Brazil|Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596, Porto Alegre, Rio Grande Do Sul, Brazil|Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141, Blumenau, Santa Catarina, Brazil|Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário, Ribeirão Preto, São Paulo, Brazil|Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365, Rio De Janeiro, Brazil|Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n, São Paulo, Brazil|Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd., Kelowna, British Columbia, Canada|Vancouver ID Research and Care Centre Society (Site 2006), Infectious Disease Clinic Downtown, Vancouver, British Columbia, Canada|Dr. Anil K. Gupta Medicine Professional Corporation (Site 2004), 1620 Albion Rd., Suite 106, Toronto, Ontario, Canada|Clinica San Agustin Research (Site 9601), Meters West from the National Bank, Desamparados, San José, Costa Rica|Corporacion GIHEMA SA (Site 9602), Carretera Prospero Fernandez, Escazú, Costa Rica|Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16, Ciudad De Guatemala, Guatemala|CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur, Torreon, Coahuila, Mexico|Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro, Oaxaca, Distrito Federal, Mexico|Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro, Guadalajara, Jalisco, Mexico|Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana, Guadalajara, Jalisco, Mexico|Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios, Culiacán, Sinaloa, Mexico|Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422, Culiacán, Sinaloa, Mexico|Eme Red Hospitalaria (Site 6010), Calle 33 No. 496, Mérida, Yucatán, Mexico|Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés, Mérida, Yucatán, Mexico|De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue, Cavite City, Cavite, Philippines|Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village, Makati City, National Capital Region, Philippines|Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive, Muntinlupa, National Capital Region, Philippines|Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II, San Juan, Puerto Rico|Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads, Kempton Park, Ekurhuleni, Gauteng, South Africa|Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue, Benoni, Gauteng, South Africa|The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive, Johannesburg, Gauteng, South Africa|Roodepoort Medicross (Site 9220), 54 Ontdekkers Road, Johannesburg, Gauteng, South Africa|Soweto ACTG CRS (Site 9203), Chris Hani Road, Johannesburg, Gauteng, South Africa|Helen Joseph Hospital (Site 9201), Perth Road, Johannesburg, Gauteng, South Africa|Setshaba Research Centre (Site 9205), 2088 Block H, Pretoria, Gauteng, South Africa|Into Research (Site 9210), Totius Street, Tshwane, Gauteng, South Africa|Durban International Clinical Research Site (Site 9208), Sidmouth Avenue, Durban, Kwazulu - Natal, South Africa|Welkom Clinical Trial Centre (Site 9211), 189 Power Road, Welkom, Matjhabeng, Free State, South Africa|The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St., Klerksdorp, North-West, South Africa|The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St., Rustenburg, North-West, South Africa|TASK Eden (Site 9218), G, 4 Victoria St., George, South Africa|CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue, Johannesburg, South Africa|Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete, Mpumalanga, South Africa|Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street, Pretoria, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 8797
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - COVID-19 symptom duration (Phase 2)|Quantification of SARS-CoV-2 RNA (Phase 2)|Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2)|Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3)|Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 3)|COVID-19 symptom duration (Phase 3)|Quantification of SARS-CoV-2 RNA (Phase 3)|Cumulative incidence of death from any cause or hospitalization due to any cause (Phase 2)|Cumulative incidence of death from any cause, or hospitalization due to any cause related to COVID-19 (Phase 3)|Level of SARS-CoV-2 RNA from NP swabs (Phase 2)|Level of SARS-CoV-2 RNA from NP swabs (Phase 3)|Duration of targeted clinical COVID-19 symptoms (Phases 2 and 3)|COVID-19 symptom severity ranking (Phases 2 and 3)|Proportion of participants with ≥1 worsening symptom of COVID-19 (Phases 2 and 3)|Time to self-reported return to usual health (a) (Phases 2 and 3)|Cumulative incidence of death due to any cause or hospitalization due to any cause (Phases 2 and 3)|Oxygen saturation level (Phases 2 and 3)|AUC of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2)|Incidence of new adverse event (AE) ≥ Grade 2 (Phases 2 and 3)|Incidence of new adverse event (AE) ≥ Grade 3 (Phases 2 and 3)|Time to self-reported return to usual health (b) (Phases 2 and 3)
NCT05074433 A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults Active, not recruiting Phase 3 Oct/25/2021 May/25/2022
  • Alternative id - R10933-10987-COV-2176|2021-005222-14
  • Interventions - Drug: casirivimab+imdevimab|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Central Alabama Research, Birmingham, Alabama, United States|Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|Stanford University, Palo Alto, California, United States|University of California, Sacramento, California, United States|Regeneron Study Site, Stanford, California, United States|James R Berenson MD Inc., West Hollywood, California, United States|University Of Colorado, Aurora, Colorado, United States|Regeneron Study Site, North Haven, Connecticut, United States|Georgetown University, Washington, District of Columbia, United States|Arthritis and Rheumatic Disease Specialties, Aventura, Florida, United States|Innovative Research of West Florida, Inc., Clearwater, Florida, United States|Midway Immunology and Research Center, Fort Pierce, Florida, United States|Elixia COVID-19, Hollywood, Florida, United States|AppleMed Research Group, LLC, Miami, Florida, United States|De La Cruz Research Center, LLC, Miami, Florida, United States|University of South Florida, Tampa, Florida, United States|Florida Medical Clinic, LLC, Zephyrhills, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Great Lakes Clinical Trials - Ravenswood, Chicago, Illinois, United States|University of Iowa, Iowa City, Iowa, United States|Tulane University, New Orleans, Louisiana, United States|Institute of Human Virology, Baltimore, Maryland, United States|Johns Hopkins Hospital, Baltimore, Maryland, United States|Laboratory of Clinical Immunology and Microbiology, NIAID, Bethesda, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|Spectrum Health, Grand Rapids, Michigan, United States|Mayo Clinic, Rochester, Minnesota, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|Jersey Shore University Medical Center, Neptune, New Jersey, United States|Holy Name, Teaneck, New Jersey, United States|Montefiore Medical Center, Bronx, New York, United States|Maimonides Cancer Center, Brooklyn, New York, United States|Icahn School of Medicine at Mount Sinai, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Regeneron Study Site 2, New York, New York, United States|Regeneron Study Site, Rochester, New York, United States|Regeneron Study Site, Syracuse, New York, United States|SUNY Upstate Medical University, Syracuse, New York, United States|Burke Primary Care, Morganton, North Carolina, United States|Gabrail Cancer Center Research, Canton, Ohio, United States|Regeneron Study Site, Cleveland, Ohio, United States|Miami Valley Hospital, Dayton, Ohio, United States|Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States|Penn Prevention Clinical Research Site, Philadelphia, Pennsylvania, United States|Temple University, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|West Tennessee Research Institute, Jackson, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|Central Texas Clinical Research, Austin, Texas, United States|Therapeutic Concepts, PA, Houston, Texas, United States|Houston Methodist Hospital, Houston, Texas, United States|MD Anderson Cancer Center, Houston, Texas, United States|Synergy Group Medical,LLC, Houston, Texas, United States|Regeneron Study Site, Richmond, Virginia, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Swedish Medical Center- First Hill, Seattle, Washington, United States|University of Wisconsin - Madison, Madison, Wisconsin, United States|Regeneron Study Site, Cuauhtemoc, Distrito Federal, Mexico
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
  • Enrollment - 66
  • Age - 12 Years and older   (Child, Adult, Older Adult)
  • Outcome measures - Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases|Proportion of participants with grade ≥3 treatment-emergent adverse events (TEAEs)|Proportion of participants with TEAEs leading to study drug discontinuation|Proportion of participants with treatment-emergent serious adverse events (SAEs)|Incidence of adverse events of special interest (AESIs)|Concentration of each mAb over time|Incidence and titer of anti-drug antibodies (ADA) over time|Incidence of neutralizing antibodies (NAb) to each mAb over time
NCT04617535 Compassionate Use of REGN-COV2 for the Treatment of COVID-19 Available Jan/01/1970 Jan/01/1970
  • Alternative id - R10933-10987-COV
  • Interventions - Drug: REGN10933+REGN10987 combination therapy
  • Study type - Expanded Access:Individual Patients
  • Study results - No Results Available
  • Locations -
  • Study designs -
  • Enrollment -
  • Age - Child, Adult, Older Adult
  • Outcome measures -
NCT04992273 COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age Active, not recruiting Phase 2 Sep/13/2021 Nov/17/2022
  • Alternative id - R10933-10987-COV-2121|2021-004590-30
  • Interventions - Drug: casirivimab+imdevimab
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Advanced Research Center, Inc, Anaheim, California, United States|Batchelor's Children's Research Institute, Miami, Florida, United States|Jacobi Medical Center, Bronx, New York, United States|Stony Brook University Hospital, Stony Brook, New York, United States|SUNY Upstate Medical University, Syracuse, New York, United States|Coastal Pediatric Research, Charleston, South Carolina, United States|Regeneron Research Site, Richmond, Virginia, United States
  • Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 28
  • Age - up to 12 Years   (Child)
  • Outcome measures - Concentrations of casirivimab+imdevimab in serum over time.|Number of participants with treatment-emergent adverse events (TEAEs)|Severity of TEAEs|Number of participants with grade ≥3 injection site reactions|Number of participants with grade ≥3 hypersensitivity reactions|Immunogenicity as measured by anti-drug antibodies (ADA) to casirivimab over time|Immunogenicity as measured by ADA to imdevimab over time|Immunogenicity as measured by neutralizing antibodies (NAb) to casirivimab over time|Immunogenicity as measured by NAb to imdevimab over time
NCT05181683 COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers Active, not recruiting Phase 1 Jan/07/2022 May/11/2022
  • Alternative id - R10933-10987-COV-2179
  • Interventions - Drug: Casirivimab+Imdevimab
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Study Site, Miami, Florida, United States|Regeneron StudySite, Winter Park, Florida, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 45
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Targeted grade ≥3 treatment-emergent adverse events (TEAEs)|Grade ≥3 injection-site reactions (ISRs)|Grade ≥2 infusion-related reactions (IRRs)|Grade ≥2 hypersensitivity reactions|Serious adverse events (SAEs)|Concentrations of casirivimab and imdevimab in serum over time|Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab|Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab
NCT04452318 COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay Completed Phase 3 Jul/13/2020 Oct/04/2021
  • Alternative id - R10933-10987-COV-2069|2020-003654-71
  • Interventions - Drug: REGN10933 + REGN10987|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Study Site, Mesa, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, La Mesa, California, United States|Regeneron Study Site, La Palma, California, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Montclair, California, United States|Regeneron Study Site, Northridge, California, United States|Regeneron Study Site, Oxnard, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, San Diego, California, United States|Regeneron Study Site, San Francisco, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Torrance, California, United States|Regeneron Study Site, Torrance, California, United States|Regeneron Study Site, Aurora, Colorado, United States|Regeneron Study Site, Colorado Springs, Colorado, United States|Regeneron Study Site, Washington, District of Columbia, United States|Regeneron Study Site, Boca Raton, Florida, United States|Regeneron Study Site, Clearwater, Florida, United States|Regeneron Study Site, DeLand, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Jacksonville, Florida, United States|Regeneron Study Site, Lakeland, Florida, United States|Regeneron Study Site, Loxahatchee Groves, Florida, United States|Regeneron Study Site, Maitland, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Orlando, Florida, United States|Regeneron Study Site, Sarasota, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, West Palm Beach, Florida, United States|Regeneron Study Site, Winter Park, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Columbus, Georgia, United States|Regeneron Study Site, Decatur, Georgia, United States|Regeneron Study Site, Eatonton, Georgia, United States|Regeneron Study Site, Marietta, Georgia, United States|Regeneron Study Site, Sandy Springs, Georgia, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site 2, Chicago, Illinois, United States|Regeneron Study Site 3, Chicago, Illinois, United States|Regeneron Study Site, Chicago, Illinois, United States|Regeneron Study Site 1, Downers Grove, Illinois, United States|Regeneron Study Site 2, Downers Grove, Illinois, United States|Regeneron Study Site, Ames, Iowa, United States|Regeneron Study Site, Lake Charles, Louisiana, United States|Regeneron Study Site, Marrero, Louisiana, United States|Regeneron Study Site, Metairie, Louisiana, United States|Regeneron Study Site, New Orleans, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Boston, Massachusetts, United States|Regeneron Study Site, Detroit, Michigan, United States|Regeneron Study Site, Royal Oak, Michigan, United States|Regeneron Study Site, Minneapolis, Minnesota, United States|Regeneron Study Site, Gulfport, Mississippi, United States|Regeneron Study Site, Jackson, Mississippi, United States|Regeneron Study Site, Hazelwood, Missouri, United States|Regeneron Study Site, Saint Louis, Missouri, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Morristown, New Jersey, United States|Regeneron Study Site, Newark, New Jersey, United States|Regeneron Study Site, Summit, New Jersey, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site 1, Bronx, New York, United States|Regeneron Study Site 2, Bronx, New York, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, Buffalo, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Chapel Hill, North Carolina, United States|Regeneron Study Site, Charlotte, North Carolina, United States|Regeneron Study Site, Fayetteville, North Carolina, United States|Regeneron Study Site, Raleigh, North Carolina, United States|Regeneron Study Site, Wilmington, North Carolina, United States|Regeneron Study Site, Winston-Salem, North Carolina, United States|Regeneron Study Site, Cincinnati, Ohio, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Danville, Pennsylvania, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Wilkes-Barre, Pennsylvania, United States|Regeneron Study Site, Providence, Rhode Island, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Clinton, South Carolina, United States|Regeneron Study Site, Gaffney, South Carolina, United States|Regeneron Study Site, Sioux Falls, South Dakota, United States|Regeneron Study Site, Chattanooga, Tennessee, United States|Regeneron Study Site, Knoxville, Tennessee, United States|Regeneron Study Site, Memphis, Tennessee, United States|Regeneron Study Site, Nashville, Tennessee, United States|Regeneron Study Site, Bellaire, Texas, United States|Regeneron Study Site, Corpus Christi, Texas, United States|Regeneron Study Site, Dallas, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Pearland, Texas, United States|Regeneron Study Site, Red Oak, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Charlottesville, Virginia, United States|Regeneron Study Site, Richmond, Virginia, United States|Regeneron Study Site, Everett, Washington, United States|Regeneron Study Site, Seattle, Washington, United States|Regeneron Study Site, Yakima, Washington, United States|Regeneron Study Site, Madison, Wisconsin, United States|Regeneron Study Site, Chisinau, Moldova, Republic of|Regeneron Study Site, Bucharest, Romania
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 3303
  • Age - Child, Adult, Older Adult
  • Outcome measures - Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) during the EAP|Proportion of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs|Proportion of participants who subsequently develop signs and symptoms (broad-term) within 14 days of a positive RT-qPCR at baseline or during the EAP|Proportion of participants with a viral load >4 (log10 copies/mL) in Nasopharyngeal (NP) swab samples during the EAP|Number of weeks of symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad term) during the EAP|Number of weeks of high viral load >4 (log10 copies/mL) in NP swab samples during the EAP|Number of weeks of RT-qPCR confirmed SARS-CoV-2 infection (regardless of symptoms) during the EAP|Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infection (regardless of symptoms) during the EAP|Proportion of participants in placebo group with a RT-qPCR confirmed SARS-CoV-2 infection during the EAP with an index case participating in study R10933-10987-COV-2067 (NCT04425629)|Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (CDC definition) during the EAP|Number of weeks of symptomatic RT-qPCR-confirmed SARS-CoV-2 infection (CDC definition) during the EAP|Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (strict-term) during the EAP|Number of weeks of symptomatic RT-qPCR confirmed SARS-CoV-2 infection (strict-term) during the EAP|Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infections at each week in the EAP|Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) at each week in the EAP|Time-weighted average of viral load (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR in NP swab samples (that has an onset during the EAP) until the third weekly visit after the first positive test during the EAP|Time-weighted average of viral load (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR in NP swab samples (that has an onset during the EAP) until the second weekly visit after the first positive test during the EAP|Maximum SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP|SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples corresponding to the onset of first positive RT-qPCR during the EAP|Area under the curve (AUC) in viral load (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR NP swab samples detected during the EAP until the first confirmed negative test|Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Proportion of participants with at least 1 COVID-19-related hospitalization or emergency room visit associated with a positive RT-qPCR during the EAP or all-cause death|Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset during the EAP|Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP|Proportion of participants in the placebo group with a RT-qPCR confirmed SARS-CoV-2 infection during the EAP with at least 1 household member participating either in study R10933-10987-COV-2067 (NCT04425629) or in cohort B|Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad-term) during the EAP|Proportion of baseline seropositive subjects (based on central lab test) with TEAEs and severity of TEAEs|Incidence of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods|Severity of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods|Concentrations of REGN10933 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test)|Concentrations of REGN10987 in serum over time and selected PK parameters in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10933 over time in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time in seronegative and seropositive participants (based on central lab test)|Immunogenicity as measured by neutralizing anti-drug antibodies (NAbs) to REGN10987 over time in seronegative and seropositive participants (based on central lab test)|Number of weeks of symptomatic SARS-CoV-2 infection (broad-term) within 14 days of a positive RT-qPCR at baseline or during the EAP|Proportion of participants who subsequently develop signs and symptoms (CDC definition) within 14 days of a positive RT-qPCR at baseline or during the EAP|Proportion of participants who subsequently develop signs and symptoms (strict-term) within 14 days of a positive RT-qPCR at baseline or during the EAP|Number of weeks of symptomatic SARS-CoV-2 infection (CDC definition) within 14 days of a positive RT-qPCR at baseline or during the EAP|Number of weeks of symptomatic SARS CoV-2 infection (strict-term) within 14 days of a postive RT-qPCR at baseline or during the EAP|Change in viral load (log10 copies/mL) from baseline to day 8 visit in NP swab samples|Change in viral load (log10 copies/mL) from baseline to day 15 visit in NP swab samples|Time-weighted average change from baseline in viral load (log10 copies/mL) in NP swab samples until the day 22 visit|Area under the curve (AUC) in viral load (log10 copies/mL) in NP swab samples from baseline to the first confirmed negative test|Maximum SARS-CoV-2 RT-qPCR viral load (log10 copies/mL) in NP swab samples during the EAP|Number of medically attended visits in emergency rooms or urgent care centers related to RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset at baseline or during the EAP|Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Number of days missed for daily responsibilities (where applicable) due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset at baseline or during the EAP|Proportion of participants with at least one COVID-19 related hospitalization or emergency room visit associated with a positive RT-qPCR at baseline or during the EAP, or all-cause death|Proportion of participants with TEAEs and severity of TEAEs|Incidence of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods|Severity of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods
NCT04666441 COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection Completed Phase 2 Dec/15/2020 Sep/21/2021
  • Alternative id - R10933-10987-COV-20145
  • Interventions - Drug: REGN10933+REGN10987 combination therapy|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Study Site, Mesa, Arizona, United States|Regeneron Study Site, Tucson, Arizona, United States|Regeneron Study Site, Canoga Park, California, United States|Regeneron Study Site, Long Beach, California, United States|Regeneron Study Site, Los Angeles, California, United States|Regeneron Study Site, Rolling Hills Estates, California, United States|Regeneron Study Site, San Francisco, California, United States|Regeneron Study Site, Santa Monica, California, United States|Regeneron Study Site, Stanford, California, United States|Regeneron Study Site, Colorado Springs, Colorado, United States|Regeneron Study Site, Washington, District of Columbia, United States|Regeneron Study Site, DeLand, Florida, United States|Regeneron Study Site, Fort Pierce, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Hialeah, Florida, United States|Regeneron Study Site, Maitland, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Saint Petersburg, Florida, United States|Regeneron Study Site, Tampa, Florida, United States|Regeneron Study Site, West Palm Beach, Florida, United States|Regeneron Study Site, Winter Haven, Florida, United States|Regeneron Study Site, Winter Park, Florida, United States|Regeneron Study Site, Atlanta, Georgia, United States|Regeneron Study Site, Columbus, Georgia, United States|Regeneron Study Site, Downers Grove, Illinois, United States|Regeneron Study Site, Ames, Iowa, United States|Regeneron Study Site, Iowa City, Iowa, United States|Regeneron Study Site, Lake Charles, Louisiana, United States|Regeneron Study Site, Marrero, Louisiana, United States|Regeneron Study Site, Shreveport, Louisiana, United States|Regeneron Study Site, Baltimore, Maryland, United States|Regeneron Study Site, Las Vegas, Nevada, United States|Regeneron Study Site, Teaneck, New Jersey, United States|Regeneron Study Site, Bronx, New York, United States|Regeneron Study Site, New York, New York, United States|Regeneron Study Site, Charlotte, North Carolina, United States|Regeneron Study Site, Durham, North Carolina, United States|Regeneron Study Site, Wilmington, North Carolina, United States|Regeneron Study Site, Columbus, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Philadelphia, Pennsylvania, United States|Regeneron Study Site, Charleston, South Carolina, United States|Regeneron Study Site, Clinton, South Carolina, United States|Regeneron Study Site, Amarillo, Texas, United States|Regeneron Study Site, Corpus Christi, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Houston, Texas, United States|Regeneron Study Site, Pearland, Texas, United States|Regeneron Study Site, Red Oak, Texas, United States|Regeneron Study Site, San Antonio, Texas, United States|Regeneron Study Site, Splendora, Texas, United States|Regeneron Study Site, Tyler, Texas, United States|Regeneron Study Site, Falls Church, Virginia, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 1164
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Time-weighted average daily change from baseline in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples|Time-weighted average daily change from baseline in viral load (log10 copies/mL)|Time-weighted average daily change from baseline in viral load (log10 copies/mL) in patients with high viral load at baseline|Proportion of patients with high viral load|Proportion of patients with viral loads below the limit of detection|Proportion of patients with viral loads below the lower limit of quantification|Change from baseline in viral load (log10 copies/mL) as measured by RT-qPCR in NP samples|Proportion of patients with treatment-emergent serious adverse events (SAEs)|Proportion of patients with infusion-related reactions (grade ≥2)|Proportion of patients with injection-site reactions (grade ≥3)|Proportion of patients with hypersensitivity reactions (grade ≥2)|Concentrations of REGN10933 in serum|Concentrations of REGN10987 in serum|Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10933|Immunogenicity as measured by neutralizing anti-drug antibody (NAb) to REGN10933|Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10987|Immunogenicity as measured by neutralizing anti-drug antibody (NAb) to REGN10987
NCT04852978 COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers Active, not recruiting Phase 2 Apr/29/2021 Nov/25/2022
  • Alternative id - R10933-10987-COV-2118
  • Interventions - Drug: casirivimab+imdevimab|Biological: Moderna mRNA-1273 vaccine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Research Site, Little Rock, Arkansas, United States|Regeneron Research Site, Rogers, Arkansas, United States|Regeneron Research Site, Hialeah, Florida, United States|Regeneron Research Site, Miami, Florida, United States|Regeneron Research Site, Orlando, Florida, United States|Regeneron Research Site, Dayton, Ohio, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 295
  • Age - 18 Years to 90 Years   (Adult, Older Adult)
  • Outcome measures - 50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein|Absolute values in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time|Change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time|Percentage change from baseline in concentrations of vaccine-induced antibodies to SARS-CoV-2 antigens over time|50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to SARS-CoV-2 S protein assessed over time after the first dose of Moderna mRNA-1273 vaccine|Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study|Proportion of participants with treatment-emergent serious adverse events (SAEs) throughout the study|Proportion of participants with infusion-related reactions (grade ≥2) to REGN10933+REGN10987|Proportion of participants with injection site reactions (grade ≥3) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine|Proportion of participants with hypersensitivity reactions (grade ≥2) to REGN10933+REGN10987 or each dose of Moderna mRNA-1273 vaccine|Concentrations of REGN10933 in serum over time|Concentrations of REGN10987 in serum over time|Immunogenicity, as measured by anti-drug antibodies (ADA) to REGN10933|Immunogenicity, as measured by ADA to REGN10987|Immunogenicity, as measured by neutralizing antibodies (NAb) to REGN10933|Immunogenicity, as measured by NAb to REGN10987
NCT05205759 Non-inferiority Trial on Monoclonal Antibodies in COVID-19 Recruiting Phase 3 Dec/09/2021 Jul/01/2022
  • Alternative id - MANTICO|2021-002612-31
  • Interventions - Drug: Bamlanivimab Etesevimab|Drug: Sotrovimab|Drug: Casirivimab-Imdevimab
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - IRCCS Policlinico di S. Orsola, Bologna, Italy|PO SS Trinità di Cagliari, Cagliari, Italy|Azienda Ospedaliera Cannizzaro, Catania, Italy|Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele, Catania, Italy|PO Garibaldi Nesima, Catania, Italy|Azienda Socio-Sanitaria Territoriale di Cremona, Cremona, Italy|Ospedale S. Maria Annunziata, Firenze, Italy|Covid Hospital Jesolo, Jesolo, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy|Azienda Ospedaliera dei Colli, presidio ospedaliero Cotugno, Napoli, Italy|Azienda Ospedaliera di Padova, Padova, Italy|AOU Policlinico, Palermo, Italy|Azienda Ospedaliera S. Maria della Misericordia, Perugia, Italy|Università degli Studi di Pescara, Pescara, Italy|Fondazione Policlinico Universitario A. Gemelli, Roma, Italy|Ospedale San Paolo ASL 2 Savonese, Savona, Italy|AOU Città della Salute e Scienza, Presidio Molinette, Torino, Italy|Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), Trieste, Italy|Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy|Azienda Ospedaliera di Verona, Verona, Italy
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 1260
  • Age - 50 Years and older   (Adult, Older Adult)
  • Outcome measures - COVID-19 progression|Visits to the Emergency Room|Duration of supplemental oxygen therapy|Duration of hospitalization|Non-invasive ventilation|Duration of non-invasive ventilation|Mechanical ventilation|Duration of mechanical ventilation|28-day mortality|90-day mortality|Duration of fever|Duration of symptoms|Duration of absence from work|Adverse events
NCT05195060 TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2 Recruiting Dec/14/2021 Jun/14/2024
  • Alternative id - NL78705.018.21
  • Interventions - Drug: casirivimab with imdevimab|Drug: sotrovimab|Drug: molnupiravir
  • Study type - Observational
  • Study results - No Results Available
  • Locations - Amsterdam University Medical centre - VUMC, Amsterdam, Noord Holland, Netherlands|Amsterdam University Medical Centre, Amsterdam, Noord-Holland, Netherlands|Leiden universitair medisch centrum, Leiden, Netherlands|Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
  • Study designs - Observational Model: Cohort|Time Perspective: Prospective
  • Enrollment - 1000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Therapeutic effect of treatment with monoclonal antibodies and antiviral agents|Incidence of Treatment-Emergent Adverse Events of treatment with monoclonal antibodies and antiviral agents|Cost-effectiveness of treatment with monoclonal antibodies and antiviral agents|Change of serologic response during treatment with monoclonal antibodies and antiviral agents
NCT04840459 Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting Recruiting Phase 2 Nov/20/2020 Jan/31/2022
  • Alternative id - 1686206
  • Interventions - Biological: BAMLANIVIMAB|Biological: CASIRIVIMAB|Biological: IMDEVIMAB
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - DHR Health Institute for Research and Development, Edinburg, Texas, United States|DHR Health, Edinburg, Texas, United States|Starr County Memorial Hospital, Rio Grande City, Texas, United States
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 1000
  • Age - 12 Years and older   (Child, Adult, Older Adult)
  • Outcome measures - Minimize and/or eliminate the number of patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization.
NCT05157997 Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail Not yet recruiting Phase 1 Jan/01/2022 Jan/01/2025
  • Alternative id - 21-1223
  • Interventions - Drug: Casirivimab and Imdevimab Antibody Cocktail
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Northwell Health Organ Transplant Center, Manhasset, New York, United States
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 14
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Monitoring for SARS-CoV-2 infection|30-day admission rate to hospital post-transplant due to COVID-19|Patient and graft survival at 30 days, 6 months and 1 year|Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail|Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
NCT05081388 COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease Active, not recruiting Phase 1|Phase 2 Nov/08/2021 Jul/08/2022
  • Alternative id - R14256-COV-2149|2021-004760-10
  • Interventions - Drug: REGN14256|Drug: imdevimab|Drug: casirivimab + imdevimab|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Research Site, La Mesa, California, United States|Ark Clinical Research, Long Beach, California, United States|PNS Clinical Research, LLC, Mission Viejo, California, United States|Regeneron Research Site, Fort Pierce, Florida, United States|AGA Clinical Trials, Hialeah, Florida, United States|Regeneron Research Site, Loxahatchee Groves, Florida, United States|Charisma Research and Medical Center, Miami Lakes, Florida, United States|Project 4 Research, Inc., Miami, Florida, United States|Universal Medical and Research Center, LLC, Miami, Florida, United States|Global Medical Trials, Miami, Florida, United States|Bio-Medical Research LLC, Miami, Florida, United States|Triple O Research Institute, P.A., West Palm Beach, Florida, United States|Regeneron Research Site, Winter Park, Florida, United States|IACT Health, Columbus, Georgia, United States|Chicago Clinical Research Institute, Chicago, Illinois, United States|Regeneron Research Site, Ames, Iowa, United States|Regeneron Research Site, Marrero, Louisiana, United States|Olive Branch Family Medical Center, Olive Branch, Mississippi, United States|Forte Family Practice, Las Vegas, Nevada, United States|New York Health and Hospitals / Lincoln, Bronx, New York, United States|NYC H+H / Jacobi Medical Center, Bronx, New York, United States|Regeneron Research Site, Wilmington, North Carolina, United States|Regeneron Research Site, Dayton, Ohio, United States|Carolina Medical Research, Clinton, South Carolina, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|Advanced Diagnostics Clinic, River Oaks Hospital and Clinics, Houston, Texas, United States|Regeneron Research Site, Houston, Texas, United States|Regeneron Research Site, Houston, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 1359
  • Age - 12 Years to 65 Years   (Child, Adult, Older Adult)
  • Outcome measures - Treatment emergent adverse events (TEAEs)|Severity of TEAEs|Proportion of patients with injection-site reactions (ISRs)|Severity of ISRs|Proportion of patients with hypersensitivity reactions|Severity of hypersensitivity reactions over time|Time-weighted average (TWA) daily change from baseline in viral load (log10 copies/mL)|Time to COVID-19 symptoms resolution|Proportion of patients with treatment-emergent serious adverse events (SAEs)|TEAEs|Proportion of patients with ISRs|Proportion of patients with treatment-emergent SAEs|Time-weighted average change from baseline in viral load|Change from baseline in viral load|Proportion of patients with viral loads below the limit of detection|Concentrations of REGN14256 in serum over time|Concentrations of imdevimab in serum over time|Incidence and titer of anti-drug antibodies (ADA) to REGN14256 over time|Incidence and titer of ADA to imdevimab over time
NCT04519437 Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19 Completed Phase 1 Jul/26/2020 Nov/22/2021
  • Alternative id - R10933-10987-HV-2093
  • Interventions - Drug: REGN10933+REGN10987|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Regeneron Study Site, Tempe, Arizona, United States|Regeneron Study Site, Rogers, Arkansas, United States|Regeneron Study Site, Sacramento, California, United States|Regeneron Study Site, Miami, Florida, United States|Regeneron Study Site, Lincoln, Nebraska, United States|Regeneron Study Site, Dayton, Ohio, United States|Regeneron Study Site, Austin, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 974
  • Age - 18 Years to 90 Years   (Adult, Older Adult)
  • Outcome measures - Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration|Concentrations of REGN10933 in serum over time|Concentrations of REGN10987 in serum over time|Proportion of participants with treatment-emergent adverse events (TEAEs)|Severity of TEAEs|Proportion of participants who achieve or exceed target concentration in serum of REGN10933|Proportion of participants who achieve or exceed target concentration in serum of REGN10987|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933|Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987