Other substances

Etesevimab

An anti-Spike (SARS-CoV-2) 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

Etesevimab is a human recombinant monoclonal antibody targeting SARS-CoV-2 Spike protein RBD. It blocks the interaction between viral Spike and the host’s ACE2 receptor and is therefore investigated in COVID-19 treatment (DrugBank).

On February 9, 2021, the FDA issued an Emergency Use Authorization 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.

Etesevimab on DrugBank
Etesevimab on Wikipedia

Synonyms

LY3832479; LY-CoV016; JS016; CB6

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 Spike protein Phase II clinical trial Randomized controlled double-blind trial Antibody Moderate severity Mild severity	Mild to moderate COVID-19 outpatients.	45.54	Etesevimab therapy in combination with bamlanivimab in mild to moderate COVID-19 patients was associated with statistically significant decrease in viral load compared to placebo.	Jan/21/2021
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
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
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: 1400 mg IV. Main outcome: Severe outcomes by day 30.	Feb/22/2022
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
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, etesevimab 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. Etesivimab was combined with bamlanivimab. Sample size: 1344 + 9009 control.	Oct/15/2022

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
A human neutralizing antibody targets the receptor-binding site of SARS-CoV-2.	Oct/20/2021
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
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
Tolerability, Safety, Pharmacokinetics, and Immunogenicity of a Novel SARS-CoV-2 Neutralizing Antibody, Etesevimab, in Chinese Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study.	Jul/16/2021
Editorial: Post-Exposure Prophylactic Neutralizing Monoclonal Antibodies to SARS-CoV-2 for Individuals at High Risk for COVID-19	Aug/16/2021
Intranasal delivery of replicating mRNA encoding neutralizing antibody against SARS-CoV-2 infection in mice	Oct/25/2021
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
Prospective mapping of viral mutations that escape antibodies used to treat COVID-19	Jan/25/2021
Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody JS016 in Hospitalized Chinese Patients with COVID-19: a Phase 2/3, Multicenter, Randomized, Open-Label, Controlled Trial	Mar/15/2022
Etesevimab in combination with JS026 neutralizing SARS-CoV-2 and its variants	Dec/27/2021
In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains.	Jun/21/2021
Impact of the N501Y substitution of SARS-CoV-2 Spike on neutralizing monoclonal antibodies targeting diverse epitopes	Apr/28/2021
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
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
In Silico Antibody Mutagenesis for Optimizing Its Binding to Spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2	Nov/04/2020
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
Perspectives on passive antibody therapy and peptide-based vaccines against emerging pathogens like SARS-CoV-2.	Jun/02/2021
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
ACE2 can act as the secondary receptor in the FcgammaR-dependent ADE of SARS-CoV-2 infection.	Dec/31/2021
Safety of Intradialytic Bamlanivimab/Etesevimab Administration in Two COVID-19 Dialysis Outpatients	Feb/02/2022
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
Integrated Biophysical Modeling of the SARS-CoV-2 Spike Protein Binding and Allosteric Interactions with Antibodies	Apr/30/2021
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
Binding and molecular basis of the bat coronavirus RaTG13 virus to ACE2 in humans and other species.	May/24/2021
Molecular rationale for SARS-CoV-2 spike circulating mutations able to escape bamlanivimab and etesevimab monoclonal antibodies	Jul/01/2020
Insights into SARS-CoV-2's Mutations for Evading Human Antibodies: Sacrifice and Survival	Nov/24/2021
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
In-Silico Analysis of Monoclonal Antibodies against SARS-CoV-2 Omicron	Feb/14/2022
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
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
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
Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID-19 Infection	Sep/24/2021
Overview of the Main Anti-SARS-CoV-2 Vaccines: Mechanism of Action, Efficacy and Safety.	Aug/31/2021

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
NCT04634409	A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness	Completed	Phase 2	Oct/29/2020	Oct/20/2021
Alternative id - 18160\|J2X-MC-PYAH Interventions - Drug: LY3819253\|Drug: LY3832479\|Drug: Placebo\|Drug: VIR-7831\|Drug: LY3853113 Study type - Interventional Study results - No Results Available Locations - University of Alabama at Birmingham, Birmingham, Alabama, United States\|The Institute for Liver Health, 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\|The Institute for Liver Health, Tucson, Arizona, 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\|Neighborhood Healthcare, 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\|Central Valley Research, LLC, Modesto, California, United States\|Inland Empire Liver Foundation, Rialto, California, United States\|Sutter Institute For Medical Research, Sacramento, 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\|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\|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\|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\|Great Lakes Clinical Trials, Chicago, Illinois, United States\|Franciscan Health Hammond, Dyer, Indiana, United States\|Qualmedica Research Evansville, Evansville, Indiana, United States\|Franciscan St. Francis Health, Indianapolis, Indiana, United States\|St.Vincent - Indy, Indianapolis, Indiana, 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\|Massachusetts General Hospital, Boston, Massachusetts, United States\|U of MA Mem Med Ctr, Worcester, Massachusetts, United States\|University of Michigan, Ann Arbor, Michigan, United States\|Great Lakes Research Group, Inc., Bay City, 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\|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\|Quality Clinical Research, Omaha, Nebraska, United States\|Excel Clinical Research, Las Vegas, Nevada, United States\|Las Vegas Medical Research, Las Vegas, Nevada, United States\|SVG Clinical, Las Vegas, Nevada, United States\|Holy Name Medical Center, Teaneck, New Jersey, United States\|Prime Global Research, LLC, Bronx, New York, United States\|Onsite Clinical Solutions, LLC, 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\|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\|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\|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\|Gadolin Research, LLC, Beaumont, Texas, United States\|Conroe Willis Medical Research, Conroe, 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\|Accurate Clinical Management, LLC., Houston, Texas, United States\|1960 Family Practice, PA, 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\|Crossroads Clin Rch-Victoria, Victoria, Texas, United States\|CLS Research Ctr, PLLC, Webster, Texas, United States\|CARE ID, Annandale, Virginia, United States\|Evergreen Health Research, Kirkland, Washington, United States\|Sanatorio Sagrado Corazón, Ciudad de Buenos Aires, AR, Argentina\|Clínica Zabala, Ciudad de Buenos Aires, AR, Argentina\|Sanatorio de la Trinidad Mitre, Caba, Buenos Aires, Argentina\|Clínica Privada Independencia, Munro, Buenos Aires, Argentina\|Go Centro Medico San Nicolás, San Nicolás, Buenos Aires, Argentina\|Instituto de Investigaciones Clinicas Zarate, Zárate, Buenos Aires, Argentina\|Instituto Médico Rio Cuarto, Rio Cuarto, Cordoba, Argentina\|Clinica Central S.A., Villa Regina, Rio Negro, Argentina\|Centro de Investigaciones Clínicas - Clínica Viedma, Viedma, RN, Argentina\|INECO Neurociencias Oroño, Rosario, Santa Fe, Argentina\|Hospital San Roque, Cordoba, Argentina\|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: Parallel Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Treatment Enrollment - 1631 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Percentage of Participants with SARS-CoV-2 Viral Load Greater than 5.27\|Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death\|Change from Baseline to Day 7 in SARS-CoV-2 Viral Load\|Percentage of Participants Demonstrating Symptom Resolution\|Percentage of Participants Demonstrating Symptom Improvement\|Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death\|Pharmacokinetics (PK): Mean Concentration of LY3819253 and LY3832479\|Pharmacokinetics (PK): Mean Concentration of LY3819253 and VIR-7831\|Pharmacokinetics (PK): Mean Concentration of LY3853113, LY3819253 and LY3832479
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
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
NCT04441918	Tolerability,Safety,Pharmacokinetic Profile and Immunogenicity of a Recombinant Humanized Anti-SARS-CoV-2 Monoclonal Antibody (JS016) for Injection in Chinese Health Subjects	Recruiting	Phase 1	Jun/05/2020	Dec/11/2020
Alternative id - JS016-001-I Interventions - Combination Product: JS016 (anti-SARS-CoV-2 monoclonal antibody) Study type - Interventional Study results - No Results Available Locations - Huashan Hospital affiliated to Fudan University, Shanghai, China Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 40 Age - 15 Years to 45 Years (Child, Adult) Outcome measures - Correlation of adverse events with the investigational product\|Primary pharmacokinetic variables
NCT04931238	Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)	Recruiting	Phase 2	Jan/20/2021	Dec/31/2022
Alternative id - Peking JS016 Interventions - Drug: JS016 Study type - Interventional Study results - No Results Available Locations - Li Weng, Beijing, Beijing, China\|Shi Jiazhuang People's Hospital, Shijia Zhuang, He Bei, China\|The First Affliated Hospital of Harbin Medical University, Harbin, Hei Longjiang, China\|Suihua first hospital, Suihua, Hei Longjiang, China Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Single (Participant)\|Primary Purpose: Treatment Enrollment - 200 Age - 18 Years to 85 Years (Adult, Older Adult) Outcome measures - Clinical status at 28 days\|All cause mortality ascertained from data analysed to day 28\|Ventilator-free days within 28 days\|Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization\|Average length of hospital stay
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
NCT05167279	A Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19	Active, not recruiting	Phase 1	Dec/17/2021	Dec/31/2022
Alternative id - JS026-001-I Interventions - Biological: JS026/placebo\|Biological: JS016/placebo Study type - Interventional Study results - No Results Available Locations - Huashan Hospital affiliated to Fudan University, Shanghai, Shanghai, China Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Treatment Enrollment - 48 Age - 18 Years to 60 Years (Adult) Outcome measures - Safety: Incidence and severity of any adverse events (AEs) occurring during the clinical trial per CTCAE V5.0\|Pharmacokinetics: AUC\|Pharmacokinetics: Tmax\|Pharmacokinetics: Cmax\|Pharmacokinetics: Vd\|Pharmacokinetics: CLt\|Pharmacokinetics: t1/2\|Immunogenicity: ADA

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