Other substances

Bamlanivimab

A potent anti-Spike (SARS-CoV-2) neutralizing monoclonal antibody.

Phase of research

Potential treatment - clinical evidence

How it helps

Antiviral

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

Bamlanivimab (also known as LY-CoV555 or LY3819253), a potent antispike neutralizing monoclonal antibody that binds with high affinity to the receptor-binding domain of SARS-CoV-2, was derived from convalescent plasma obtained from a patient with COVID-19 (Jones et al., 2021). The antibody was developed by Eli Lilly after its discovery by researchers at AbCellera and at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases.

On November 9, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA)* for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

On February 9, 2021, the FDA issued an EUA* for emergency use of bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab are neutralizing IgG1 monoclonal antibodies that bind to distinct but overlapping epitopes within the receptor binding domain of the spike protein of SARS-CoV-2. They are both investigational drugs and are not currently approved for any indication.

*FDA has revoked the authorization for bamlanivimab and etesevimab based on the high Omicron prevalence in all U.S. regions.

Bamlanivimab on DrugBank
Bamlanivimab on Wikipedia

Synonyms

LY-CoV555

Marketed as

BAMLANIVIMAB

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 Outpatients Antibody Moderate severity Mild severity	Patients	74.70	one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11	Oct/28/2020
The neutralizing antibody, LY-CoV555, protects against SARS-CoV-2 infection in non-human primates Spike protein Cryo-EM Crystallization Biophysical assay Animal model In vitro Antibody	in vitro binding assay; in vitro biophysical assay; cryo-EM; crystallization; Vero E6 cells; rhesus macaque; SARS-CoV-2 Spike-pseudotyped virus; SARS-CoV-2 INMI-1 and USA/WA-1/2020 isolates	16.30	The antibody potently bound SARS-CoV-2 Spike RBD, inhibited its interaction with host ACE2, and displayed neutralizing activity in vitro. In a cynomolgus monkey viral challenge, a reduction of viral replication in respiratory tract was observed in the case of prophylactic dosing.	Apr/05/2021
Bamlanivimab for treatment of COVID‐19 in solid organ transplant recipients: Early single‐center experience Spike protein Case series Antibody	Solid organ transplant recipients with COVID-19.	1.67	None of the mild to moderate COVID-19 patients, who were solid organ transplant recipients (liver or/and kidney or heart), experienced symptom worsening or required hospitalization.	Feb/17/2021
Circulating SARS-CoV-2 spike N439K variants maintain fitness while evading antibody-mediated immunity Spike protein Spike variant Crystallization Biophysical assay Protein factor In vitro Antibody In silico	Vero E6 cells; Vero E6-hACE2(-TMPRSS2) cells; (VSV) SARS-CoV-2 Spike-pseudotyped virus	41.58	The antibody neutralized Spike (also N439K/K417V)-pseudotyped SARS-CoV-2 in vitro.	Mar/04/2021
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: 700 mg IV. 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
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
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. Sample size: 500 + 181 imdevimab/casirivimab for comparison. Dosage: 700 mg IV. Main outcome: Severe outcomes by day 30.	Feb/22/2022
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: 700 mg IV.	Feb/01/2022
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: 700 mg in 200 mL normal saline and administered as a single intravenous infusion for approximately 1 h.	Jul/09/2021
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 700 mg of bamlanivimab.	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 Cohort study Mild	"A patient with blastic plasmacytoid dendritic cell neoplasm"		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 700 mg of bamlanivimab.	Feb/17/2022
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. Bamlavinimab was prescribed alone or in combination with etesivimab. Sample size: 1344 + 9009 control.	Oct/15/2022
Neutralizing Monoclonal Antibody Treatment Reduces Hospitalization for Mild and Moderate Coronavirus Disease 2019 (COVID-19): A Real-World Experience Spike protein Protein factor Antibody Moderate severity Mild severity Cohort study	Patients		Treatment with monoclonal antibody led to a decrease in hospital usage, particularly if administered within a few days after the onset of symptoms. Sample size: 707 + 1709 control. Main outcome: Hospitalization with a diagnosis of COVID-19 until the 30th day.	Jun/24/2021

AI-suggested references

Link	Publication date
A randomized, placebo-controlled clinical trial of bamlanivimab and etesevimab together in high-risk ambulatory patients with COVID-19 and validation of the prognostic value of persistently high viral load.	Jul/29/2021
Initial experience of bamlanivimab monotherapy use in solid organ transplant recipients.	Mar/30/2021
Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization.	May/05/2020
Bamlanivimab plus etesevimab treatment have a better outcome against COVID-19: A meta-analysis.	Dec/30/2021
Atrial fibrillation with aberrant ventricular conduction after receiving Bamlanivimab/Etesevimab: a case report.	Jun/01/2022
Immune treatment in COVID-19.	Oct/05/2021
Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.	May/19/2022
SARS-CoV-2 neutralizing antibodies for COVID-19: Outcomes for bamlanivimab versus bamlanivimab-etesevimab combination in a racially diverse cohort of patients with significant comorbidities.	May/28/2022
Comprehensive Treatment of Hematological Patients with SARS-CoV-2 Infection Including Anti-SARS-CoV-2 Monoclonal Antibodies: A Single-Center Experience Case Series	Dec/08/2020
Editorial: Post-Exposure Prophylactic Neutralizing Monoclonal Antibodies to SARS-CoV-2 for Individuals at High Risk for COVID-19	Aug/16/2021
Bamlanivimab use in mild-to-moderate COVID-19 disease: A matched cohort design	May/03/2022
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.	Jan/21/2021
Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial.	Jun/03/2021
Emergence of the E484K mutation in SARS-COV-2-infected immunocompromised patients treated with bamlanivimab in Germany	Jan/14/2022
In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains.	Jun/21/2021
Efficacy of Bamlanivimab in Reducing Hospitalization and Mortality Rates in COVID-19 Patients in a Rural Community	Jul/19/2021
Emergence of E484K Mutation Following Bamlanivimab Monotherapy among High-Risk Patients Infected with the Alpha Variant of SARS-CoV-2	Aug/19/2021
SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.	Sep/02/2021
Real-world Assessment of 2879 COVID-19 Patients Treated With Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study	Dec/06/2021
Effect of monoclonal antibody therapy on the endogenous SARS-CoV-2 antibody response	Feb/24/2022
Neutralizing Monoclonal Antibody Treatment Reduces Hospitalization for Mild and Moderate COVID-19: A Real-World Experience	Jan/07/2021
SARS-CoV-2 Variants of Concern and Variants of Interest Receptor Binding Domain Mutations and Virus Infectivity	Jan/28/2022
Early Administration of Bamlanivimab in Combination with Etesevimab Increases the Benefits of COVID-19 Treatment: Real-World Experience from the Liguria Region	Oct/13/2021
B.1.617.2 enters and fuses lung cells with increased efficiency and evades antibodies induced by infection and vaccination.	Sep/28/2021
Antibody escape and global spread of SARS-CoV-2 lineage A.27	Sep/30/2021
Clinical Impact of the Early Use of Monoclonal Antibody LY-CoV555 (Bamlanivimab) on Mortality and Hospitalization Among Elderly Nursing Home Patients: A Multicenter Retrospective Study.	Jan/31/2021
Relationship between gene expression patterns from nasopharyngeal swabs and serum biomarkers in patients hospitalized with COVID-19, following treatment with the neutralizing monoclonal antibody bamlanivimab	Jul/11/2020
Bamlanivimab and Etesevimab Improve Symptoms and Associated Outcomes in Ambulatory Patients at Increased Risk for Severe Coronavirus Disease 2019: Results From the Placebo-Controlled Double-Blind Phase 3 BLAZE-1 Trial	Jun/01/2020
In Silico Analyses on the Comparative Potential of Therapeutic Human Monoclonal Antibodies Against Newly Emerged SARS-CoV-2 Variants Bearing Mutant Spike Protein	Jan/10/2022
Perspectives on passive antibody therapy and peptide-based vaccines against emerging pathogens like SARS-CoV-2.	Jun/02/2021
Bamlanivimab Use in a Military Treatment Facility	Mar/09/2022
SARS-CoV-2 Variants in Immunocompromised Patient Given Antibody Monotherapy	Aug/05/2021
Structure-Function Analysis of Resistance to Bamlanivimab by SARS-CoV-2 Variants Kappa, Delta, and Lambda	Jul/02/2020
Impact of New Variants on SARS-CoV-2 Infectivity and Neutralization: A Molecular Assessment of the Alterations in the Spike-Host Protein Interactions	Feb/17/2022
Monoclonal Antibody Therapy in a Vaccine Breakthrough SARS-CoV-2 Hospitalized Delta (B.1.617.2) Variant Case	Jun/07/2020
An update of antispike severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies	Mar/29/2022
Emergence and onward transmission of a SARS-CoV-2 E484K variant among household contacts of a bamlanivimab-treated patient.	Feb/03/2022
Clinical outcomes of monoclonal antibody therapy during a COVID-19 outbreak in a skilled nursing facility:Arizona, 2021	Dec/30/2020
Real-World Clinical Outcomes of Bamlanivimab and Casirivimab-Imdevimab among High-Risk Patients with Mild to Moderate Coronavirus Disease 2019	Jul/20/2021
SARS-CoV-2 variant B.1.617 is resistant to bamlanivimab and evades antibodies induced by infection and vaccination.	Jun/29/2021
First-in-Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID-19	Apr/17/2020
Safety of Intradialytic Bamlanivimab/Etesevimab Administration in Two COVID-19 Dialysis Outpatients	Feb/02/2022
Impact of Bamlanivimab Monoclonal Antibody Treatment on Hospitalization and Mortality Among Nonhospitalized Adults With Severe Acute Respiratory Syndrome Coronavirus 2 Infection.	May/17/2021
Development and application of therapeutic antibodies against COVID-19	Apr/10/2021
Neutralizing Antibody Therapeutics for COVID-19.	Apr/07/2021
Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline	Dec/16/2020
Evolution of spike mutations following antibody treatment in two immunocompromised patients with persistent COVID-19 infection	Nov/13/2021
Endogenous Antibody Responses to SARS-CoV-2 in Patients With Mild or Moderate COVID-19 Who Received Bamlanivimab Alone or Bamlanivimab and Etesevimab Together.	Dec/09/2021
Successful treatment of prolonged COVID-19 with Bamlanivimab in a patient with severe B-Cell aplasia due to treatment with an anti-CD20 monoclonal antibody: A case report	Feb/16/2022
Molecular rationale for SARS-CoV-2 spike circulating mutations able to escape bamlanivimab and etesevimab monoclonal antibodies	Jul/01/2020
Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19.	Jan/01/2022
Omicron: A Heavily Mutated SARS-CoV-2 Variant Exhibits Stronger Binding to ACE2 and Potently Escapes Approved COVID-19 Therapeutic Antibodies	Dec/28/2021
Fruitful Neutralizing Antibody Pipeline Brings Hope To Defeat SARS-Cov-2	Jul/31/2020
Emerging antibody-based therapeutics against SARS-CoV-2 during the global pandemic.	Nov/24/2020
501Y.V2 and 501Y.V3 variants of SARS-CoV-2 lose binding to bamlanivimab in vitro	Mar/06/2021
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
SARS-CoV-2 variants C.1.2 and B.1.621 (Mu) partially evade neutralization by antibodies elicited upon infection or vaccination	Aug/28/2021
PK/PD modeling links accelerated resolution of COVID-19-related clinical symptoms to SARS-CoV-2 viral load reduction in patients following treatment with Bamlanivimab alone or Bamlanivimab and Etesevimab together	Apr/05/2022
Spike Gene Evolution and Immune Escape Mutations in Patients with Mild or Moderate Forms of COVID-19 and Treated with Monoclonal Antibodies Therapies	Jan/24/2022
Real-world Effect of Monoclonal Antibody Treatment in COVID-19 Patients in a Diverse Population in the United States	Jul/24/2021
Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19	Dec/29/2021
Influence of treatment with neutralizing monoclonal antibodies on the SARS-CoV-2 nasopharyngeal load and quasispecies	Jun/13/2020
Impact of early versus late administration of bamlanivimab on readmissions in patients with high-risk COVID-19.	Aug/16/2021
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
SARS-CoV-2 Spike Protein-Directed Monoclonal Antibodies May Ameliorate COVID-19 Complications in APECED Patients.	Aug/24/2021
Bamlanivimab and Etesevimab administered in an outpatient setting for SARS-CoV-2 infection	Feb/09/2022
Initial Experience With SARS-CoV-2-Neutralizing Monoclonal Antibodies in Kidney or Combined Kidney-Pancreas Transplant Recipients	Mar/31/2022
Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID-19 Infection	Sep/24/2021
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
The Efficacy of Bamlanivimab in Reducing Emergency Department Visits and Hospitalizations in a Real-world Setting	Apr/08/2022
Bamlanivimab Efficacy in Older and High-BMI Outpatients With COVID-19 Selected for Treatment in a Lottery-Based Allocation Process	Jan/29/2021
Overview of the Main Anti-SARS-CoV-2 Vaccines: Mechanism of Action, Efficacy and Safety.	Aug/31/2021
Emergence of SARS-COV-2 Spike Protein Escape Mutation Q493R after Treatment for COVID-19	Jul/27/2021
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
NCT04796402	A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19	Active, not recruiting	Phase 4	Mar/17/2021	Dec/31/2021
Alternative id - FHREB 2021-023 Interventions - Biological: Bamlanivimab\|Other: Standard of Care Study type - Interventional Study results - No Results Available Locations - Fraser Health Authority, Fraser Health Region, British Columbia, Canada Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 576 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Any incidence of admission to hospital for >24 hours in the 28 days following first positive test for SARS-CoV2.\|Any incidence of admission to hospital for >24 hours following first positive test for SARS-CoV2.\|Mortality following first positive test for SARS-CoV2.\|Health-related quality of life assessment.\|Hospitalization by age and comorbidities.\|Incidence and types of adverse reactions including anaphylaxis.\|Recruitment rate.\|Overall satisfaction with participation in research.\|Type and frequency of viral variants in patients receiving bamlanivimab.
NCT04427501	A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness	Completed	Phase 2\|Phase 3	Jun/17/2020	Dec/14/2021
Alternative id - 17947\|J2W-MC-PYAB Interventions - Drug: LY3819253\|Drug: LY3832479\|Drug: Placebo Study type - Interventional Study results - Has Results Locations - University of Alabama at Birmingham, Birmingham, Alabama, United States\|Arizona Clin Trials-Mesa, Mesa, Arizona, United States\|Perseverance Research Center, Scottsdale, Arizona, United States\|CRI of Arizona, LLC, Sun City West, Arizona, United States\|Fiel Family and Sports Medicine PC, Tempe, Arizona, United States\|Orange Grove Banner Clinic, Tucson, Arizona, United States\|Arizona Clin Trials-Tucson, Tucson, Arizona, United States\|Arkansas Children's, Little Rock, Arkansas, United States\|KLR Business Group, Inc. dba Arkansas Clinical Research, Little Rock, Arkansas, United States\|Applied Rsch Ctr - Arkansas Inc., Little Rock, Arkansas, United States\|Smart Cures Clin Research, Anaheim, California, United States\|Hope Clinical Research, Canoga Park, California, United States\|VCT-Covina, Covina, California, United States\|AMCR Institute, Escondido, California, United States\|Chemidox Clinical Trials, Lancaster, California, United States\|Ark Clinical Research, Long Beach, California, United States\|Long Beach Clinical Trials LLC, Long Beach, California, United States\|Cedars Sinai Medical Center, Los Angeles, California, United States\|UCLA Mattel Children's Hospital, Los Angeles, California, United States\|Central Valley Research, LLC, Modesto, California, United States\|Catalina Research Institute, LLC, Montclair, California, United States\|Inland Empire Liver Foundation, Rialto, California, United States\|Sutter Institute For Medical Research, Sacramento, California, United States\|Zion Medical Center, San Diego, California, United States\|Kaiser Permanente - SD Med Ctr, San Diego, California, United States\|Wolverine Clinical Trials, LLC, Santa Ana, California, United States\|St. Joe Heritage HC-Santa Rosa, Santa Rosa, California, United States\|Stanford University Hospital, Stanford, California, United States\|Mazur, Statner, Dutta, Nathan, Thousand Oaks, California, United States\|South Bay Clinical Research Institute, Torrance, California, United States\|Infect Disease Doctors Med Grp, Walnut Creek, California, United States\|Allianz Research Institute, Westminster, California, United States\|Future Innovative Treatments LLC, Colorado Springs, Colorado, United States\|Nemours Childrens Clinic - Delaware Valley of The Nemours Foundation, Wilmington, Delaware, United States\|Georgetown Univ Sch of Med, Washington, District of Columbia, United States\|Synergy Healthcare LLC, Bradenton, Florida, United States\|Holy Cross Hospital Inc., Fort Lauderdale, Florida, United States\|I R & Health Center, Inc., Hialeah, Florida, United States\|Encore Medical Research, Hollywood, Florida, United States\|Elixia CRC, Hollywood, Florida, United States\|University of Florida Jacksonville, Jacksonville, Florida, United States\|Lakeland Regional Medical Center, Lakeland, Florida, United States\|Panax Clinical Research, Miami Lakes, Florida, United States\|Hope Clinical Trials, Inc., Miami, Florida, United States\|Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States\|Bio-Medical Research, LLC, Miami, Florida, United States\|Clinical Site Partners, LLC d/b/a CSP Miami, Miami, Florida, United States\|GCPR, Saint Petersburg, Florida, United States\|Testing Matters Lab, Sunrise, Florida, United States\|Advent Health Tampa, Tampa, Florida, United States\|Triple O Research Inst, West Palm Beach, Florida, United States\|Encore Medical Research - Weston, Weston, Florida, United States\|Clinical Site Partners, LLC DBA CSP Orlando, Winter Park, Florida, United States\|Gwinnett Research Inst, Buford, Georgia, United States\|Paramount Rch Sol - College Pk, College Park, Georgia, United States\|IACT Health - VHC, Columbus, Georgia, United States\|Central Georgia Infectious Disease, Macon, Georgia, United States\|Rophe Adult and Pediatric Medicine, Union City, Georgia, United States\|Rocky Mountain Clinical Research, Idaho Falls, Idaho, United States\|Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States\|Northwestern University, Chicago, Illinois, United States\|J H. Stroger Hosp of Cook Co, Chicago, Illinois, United States\|University of Chi Med Center, Chicago, Illinois, United States\|Great Lakes Clinical Trials - Andersonville, Chicago, Illinois, United States\|Franciscan Health Hammond, Dyer, Indiana, United States\|Qualmedica Research Evansville, Evansville, Indiana, United States\|Community Hospital South, Indianapolis, Indiana, United States\|Franciscan St. Francis Health, Indianapolis, Indiana, United States\|St.Vincent - Indy, Indianapolis, Indiana, United States\|University of Louisville, Louisville, Kentucky, United States\|Qualmedica Research, LLC, Owensboro, Kentucky, United States\|Tandem Clinical Research,LLC, Marrero, Louisiana, United States\|Imperial Health Urgent Care Center - Moss Bluff, Moss Bluff, Louisiana, United States\|Nola Research Works, LLC, New Orleans, Louisiana, United States\|University of Maryland Medical Center, Baltimore, Maryland, United States\|Institute for Advanced Clinical Trials for Children, Rockville, Maryland, United States\|Massachusetts General Hospital, Boston, Massachusetts, United States\|U of MA Mem Med Ctr, Worcester, Massachusetts, United States\|University of Michigan Health Systems, Ann Arbor, Michigan, United States\|Great Lakes Research Group, Inc., Bay City, Michigan, United States\|Childrens Hospital of Michigan, Detroit, Michigan, United States\|Henry Ford Hospital, Detroit, Michigan, United States\|Revive Research Institute, Farmington Hills, Michigan, United States\|Revival Research Institute, Sterling Heights, Michigan, United States\|Sky Clinical Prime and Health Wellness Clinic, Fayette, Mississippi, United States\|University of Mississippi Medical Center, Jackson, Mississippi, United States\|Olive Branch Family Medical Center, Olive Branch, Mississippi, United States\|Sky Clin Resch - Quinn HC, Ridgeland, Mississippi, United States\|Bio-Kinetic Clinical Applications, LLC, Springfield, Missouri, United States\|Be Well Clinical Studies, Lincoln, Nebraska, United States\|Childrens Endocrine Clinic, Omaha, Nebraska, United States\|Quality Clinical Research, Omaha, Nebraska, United States\|Excel Clinical Research, Las Vegas, Nevada, United States\|Las Vegas Medical Research, Las Vegas, Nevada, United States\|SG Clinical Research - PC, Las Vegas, Nevada, United States\|Robert Wood Johnson University Medical School, New Brunswick, New Jersey, United States\|Holy Name Medical Center, Teaneck, New Jersey, United States\|Care Access Research - Bronx, Bronx, New York, United States\|Icahn Sch of Med at Mt. Sinai, New York, New York, United States\|University of North Carolina, Chapel Hill, North Carolina, United States\|OnSite Clinical Solutions, Charlotte, North Carolina, United States\|East Carolina University, Greenville, North Carolina, United States\|Monroe Biomed Research, Monroe, North Carolina, United States\|Carteret Medical Group, Morehead City, North Carolina, United States\|Carolina Research Center, Inc., Shelby, North Carolina, United States\|PMG Research of Wilmington, Wilmington, North Carolina, United States\|Valley Medical Primary Care, Centerville, Ohio, United States\|Hometown UC and Rch- Cincy, Cincinnati, Ohio, United States\|Cleveland Clinic Foundation, Cleveland, Ohio, United States\|OH State Univ College of Med, Columbus, Ohio, United States\|Aventiv Research Inc, Columbus, Ohio, United States\|Urgent Care Specialists, LLC, Columbus, Ohio, United States\|Remington-Davis, Inc, Columbus, Ohio, United States\|Urgent Care Specialists, LLC, Dayton, Ohio, United States\|META Medical Research Institute, Dayton, Ohio, United States\|Ascension St. John Tulsa OK, Tulsa, Oklahoma, United States\|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States\|Jefferson Hosp for Neurosci, Philadelphia, Pennsylvania, United States\|Temple University Hospital, Philadelphia, Pennsylvania, United States\|Hasbro Children's Hospital, Providence, Rhode Island, United States\|VITALINK - Anderson, Anderson, South Carolina, United States\|Carolina Medical Research - Clinton, Clinton, South Carolina, United States\|VITALINK - Gaffney, Gaffney, South Carolina, United States\|Carolina Medical Research - Greenville, Greenville, South Carolina, United States\|VITALINK - Greenville, Greenville, South Carolina, United States\|VITALINK - Spartanburg, Spartanburg, South Carolina, United States\|VITALINK - Union, Union, South Carolina, United States\|Univ Diab & Endo Consult, Chattanooga, Tennessee, United States\|New Phase Research and Development, Knoxville, Tennessee, United States\|St Jude Childrens Research Hospital, Memphis, Tennessee, United States\|Gadolin Research, LLC, Beaumont, Texas, United States\|Conroe Willis Medical Research, Conroe, Texas, United States\|Driscoll Children's Hospital, Corpus Christi, Texas, United States\|Crossroads Clinical Research, Corpus Christi, Texas, United States\|B S & W Med Center, Dallas, Texas, United States\|Baylor - Fort Worth, Fort Worth, Texas, United States\|North Texas Clinical Trials, LLC, Fort Worth, Texas, United States\|Houston Methodist Research Ins, Houston, Texas, United States\|Next Level Urgent Care, Houston, Texas, United States\|Centex-Houston, Houston, Texas, United States\|Accurate Clinical Management, LLC., Houston, Texas, United States\|BioPharma Clinc Site, Houston, Texas, United States\|Centex-Wesfield, Houston, Texas, United States\|B S & W Med Center, Irving, Texas, United States\|Zion Urgent Care Clinic, Katy, Texas, United States\|BioPharma Family Practice Center McAllen, McAllen, Texas, United States\|BRCR Medical Center, Inc, McAllen, Texas, United States\|North Hills Medical Research, North Richland Hills, Texas, United States\|Bay Area Infectious Diseases Associates, Pasadena, Texas, United States\|Epic Medical Research, Red Oak, Texas, United States\|Baylor - Round Rock, Round Rock, Texas, United States\|Sun Research Institute, San Antonio, Texas, United States\|Consano Clinical Research, LLC, Shavano Park, Texas, United States\|APD Clinical Research, Splendora, Texas, United States\|Baylor Scott and White Medical Center, Temple, Texas, United States\|Crossroads Clin Rch-Victoria, Victoria, Texas, United States\|CLS Research Ctr, PLLC, Webster, Texas, United States\|CARE ID, Annandale, Virginia, United States\|Virginia Commonwealth University, Richmond, Virginia, United States\|Evergreen Health Research, Kirkland, Washington, United States\|West Virginia University Hospital, Morgantown, West Virginia, United States\|Advanced Clinical Research, LLC, Bayamon, Puerto Rico\|Dorado Medical Complex Inc, Dorado, Puerto Rico\|GCM Medical Group, PSC - Hato Rey Site, San Juan, Puerto Rico Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Treatment Enrollment - 3290 Age - Child, Adult, Older Adult Outcome measures - Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups\|Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo\|Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load\|Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)\|Phase 3: Percentage of Participants Demonstrating Symptom Resolution\|Phase 3: Percentage of Participants Demonstrating Symptom Improvement\|Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause\|Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load\|Phase 3: Time to Sustained Symptom Resolution\|Phase 3: Time to SARS-CoV-2 Viral Clearance\|Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization\|Phase 2: Percentage of Participants Demonstrating Symptom Resolution\|Phase 2: Percentage of Participants Demonstrating Symptom Improvement\|Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab\|Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab\|Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause\|Phase 2: Time to SARS-CoV-2 Viral Clearance
NCT04603651	Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19	No longer available		Jan/01/1970	Jan/01/1970
Alternative id - 18165\|J2X-MC-Y001 Interventions - Drug: Bamlanivimab Study type - Expanded Access:Individual Patients Study results - No Results Available Locations - Study designs - Enrollment - Age - 12 Years and older (Child, Adult, Older Adult) Outcome measures -
NCT04656691	At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19	Terminated	Phase 4	Jan/04/2021	Apr/18/2021
Alternative id - 2020-0081_ Interventions - Drug: bamlanivimab Study type - Interventional Study results - Has Results Locations - QueryLab, Minnetonka, Minnesota, United States Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 139 Age - 65 Years and older (Older Adult) Outcome measures - Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28\|Safety - Documenting Adverse Events After Infusion
NCT04411628	A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19	Completed	Phase 1	May/28/2020	Aug/26/2020
Alternative id - 17823\|J2W-MC-PYAA Interventions - Drug: LY3819253\|Drug: Placebo Study type - Interventional Study results - Has Results Locations - Cedars Sinai Medical Center, Los Angeles, California, United States\|Veterans Affairs Medical Center San Diego, San Diego, California, United States\|Emory University, Atlanta, Georgia, United States\|Massachusetts General Hospital, Boston, Massachusetts, United States\|University of Massachusetts Medical Center, Worcester, Massachusetts, United States\|University of Michigan, Ann Arbor, Michigan, United States\|Quality Clinical Research, Inc., Omaha, Nebraska, United States\|Alexandria Center for Life - NYC/ NYCEDC, New York, New York, United States\|University of North Carolina, Chapel Hill, North Carolina, United States\|Unified Research Enterprise Brody School of Medicine at ECU, Greenville, North Carolina, United States\|Temple Univ School of Med, Philadelphia, Pennsylvania, United States Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Basic Science Enrollment - 26 Age - 18 Years to 75 Years (Adult, Older Adult) Outcome measures - Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration\|Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29\|Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load\|Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC\|Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance
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
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)
NCT04497987	A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff	Completed	Phase 3	Aug/02/2020	May/20/2021
Alternative id - 18063\|J2X-MC-PYAD\|CoVPN #3501 Interventions - Drug: Bamlanivimab\|Drug: Placebo\|Drug: Etesevimab Study type - Interventional Study results - Has Results Locations - Unv of AL Sch of Med Div of Infectious Diseases, Birmingham, Alabama, United States\|Care Access Research, Phoenix, Arizona, United States\|Allergy and Asthma Clin of NW Ark, Bentonville, Arkansas, United States\|Care Access Research LLC, Huntington Beach, California, United States\|Alta Bates SMC, Oakland, California, United States\|University of Colorado-Anschultz Medical Campus, Aurora, Colorado, United States\|NIAID, Miami, Florida, United States\|NIAID, Decatur, Georgia, United States\|Belmont Village Lincoln Park, Lincoln Park, Illinois, United States\|Family Medicine, Indianapolis, Indiana, United States\|University of Louisville, Louisville, Kentucky, United States\|Care Access Rch Lake Charles, Lake Charles, Louisiana, United States\|Tulane University School of Medicine, New Orleans, Louisiana, United States\|NIAID - National Institute of Allergy & Infectious Diseases, Bethesda, Maryland, United States\|Care Access, Boston, Massachusetts, United States\|St. Paul IDA-CARe, Saint Paul, Minnesota, United States\|Care Access, Jackson, Mississippi, United States\|University of Mississippi Medical Center, Jackson, Mississippi, United States\|Children's Hospital & Medical Center, Omaha, Nebraska, United States\|Care Access Research - Bronx, Bronx, New York, United States\|NIAD, Chapel Hill, North Carolina, United States\|Valley Medical Primary Care, Centerville, Ohio, United States\|Univ of Cin College of Med, Cincinnati, Ohio, United States\|OSU Med Intl Med Houston Ctr, Tulsa, Oklahoma, United States\|Donahoe Manor, Bedford, Pennsylvania, United States\|Belmont Village, West Univ, Houston, Texas, United States\|Burke Internal Medicine and Research, Burke, Virginia, United States Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Prevention Enrollment - 1180 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Percentage of Participants With COVID-19\|Percentage of Participants With Moderate or Worse Severity COVID-19\|Percentage of Participants With SARS-CoV-2\|Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19\|Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death\|Percentage of Participants Who Die Due to COVID-19\|Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
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
NCT04701658	A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)	Completed	Phase 2	Feb/01/2021	Jun/22/2021
Alternative id - 18216\|J2X-MC-PYAJ Interventions - Drug: Bamlanivimab Study type - Interventional Study results - Has Results Locations - Presbyterian Medical Center, Albuquerque, New Mexico, United States Study designs - Allocation: Non-Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 109 Age - 12 Years and older (Child, Adult, Older Adult) Outcome measures - Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause\|Percentage of Participants With a COVID-19-related Hospitalization\|Percentage of Participants With a COVID-related Emergency Department (ED) Visit
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.

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