Official Title
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19
Brief Summary

The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 - To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) - To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

Completed
COVID-19

Drug: REGN10933+REGN10987 combination therapy

Administered intravenously (IV) single dose
Other Name: Array

Drug: Placebo

Placebo IV Single Dose

Eligibility Criteria

Key Inclusion Criteria:

- Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2
antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such
as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization and no
alternative explanation for current clinical condition. A historical record of
positive result from test conducted ≤72 hours prior to randomization is acceptable.

- Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10
days before randomization

- Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients
meeting more than one criterion will be categorized in the most severely affected
category:

1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen

2. Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the
protocol

3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined
in the protocol

4. Cohort 3: On mechanical ventilation

Key Exclusion Criteria:

- Phase 1 Only: Patients maintaining O2 saturation >94% on room air

- In the opinion of the investigator, unlikely to survive for >48 hours from screening

- Receiving extracorporeal membrane oxygenation (ECMO)

- Has new-onset stroke or seizure disorder during hospitalization

- Initiated on renal replacement therapy due to COVID-19

NOTE: Other protocol defined inclusion / exclusion criteria apply

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Chile
Mexico
Moldova, Republic of
Romania
United States
Locations

Regeneron Study Site
Birmingham, Alabama, United States

Regeneron Study Site
Chandler, Arizona, United States

Regeneron Study Site
Phoenix, Arizona, United States

Regeneron Study Site 1
Tucson, Arizona, United States

Regeneron Study Site
Long Beach, California, United States

Regeneron Study Site
Mission Hills, California, United States

Regeneron Study Site
Sacramento, California, United States

Regeneron Study Site
Santa Monica, California, United States

Regeneron Study Site
Stanford, California, United States

Regeneron Study Site
Aurora, Colorado, United States

Regeneron Study Site
Boca Raton, Florida, United States

Regeneron Study Site
Fort Pierce, Florida, United States

Regeneron Study Site
Gainesville, Florida, United States

Regeneron Study Site
Orlando, Florida, United States

Regeneron Study Site
Pensacola, Florida, United States

Regeneron Study Site
Sarasota, Florida, United States

Regeneron Study Site
Tampa, Florida, United States

Regeneron Study Site
Atlanta, Georgia, United States

Regeneron Study Site
Atlanta, Georgia, United States

Regeneron Study Site
Augusta, Georgia, United States

Regeneron Study Site
Marietta, Georgia, United States

Regeneron Study Site
Chicago, Illinois, United States

Regeneron Study Site
Chicago, Illinois, United States

Regeneron Study Site
Glenview, Illinois, United States

Regeneron Study Site
Urbana, Illinois, United States

Regeneron Study Site
Indianapolis, Indiana, United States

Regeneron Study Site
Iowa City, Iowa, United States

Regeneron Study Site
Louisville, Kentucky, United States

Regeneron Study Site
Louisville, Kentucky, United States

Regeneron Study Site
New Orleans, Louisiana, United States

Regeneron Study Site
New Orleans, Louisiana, United States

Regeneron Study Site
Baltimore, Maryland, United States

Regeneron Study Site
Boston, Massachusetts, United States

Regeneron Study Site
Boston, Massachusetts, United States

Regeneron Study Site
Boston, Massachusetts, United States

Regeneron Study Site
Grand Rapids, Michigan, United States

Regeneron Study Site
Royal Oak, Michigan, United States

Regeneron Study Site
Rochester, Minnesota, United States

Regeneron Study Site
Chesterfield, Missouri, United States

Regeneron Study Site
Saint Louis, Missouri, United States

Regeneron Study Site
Saint Louis, Missouri, United States

Regeneron Study Site
Omaha, Nebraska, United States

Regeneron Study Site
Las Vegas, Nevada, United States

Regeneron Study Site
Englewood, New Jersey, United States

Regeneron Study Site
Hackensack, New Jersey, United States

Regeneron Study Site
Morristown, New Jersey, United States

Regeneron Study Site
Neptune, New Jersey, United States

Regeneron Study Site
Pennington, New Jersey, United States

Regeneron Study Site
Summit, New Jersey, United States

Regeneron Study Site
Teaneck, New Jersey, United States

Regeneron Study Site
Albuquerque, New Mexico, United States

Regeneron Study Site
Bronx, New York, United States

Regeneron Study Site
Bronx, New York, United States

Regeneron Study Site
Brooklyn, New York, United States

Regeneron Study Site
Buffalo, New York, United States

Regeneron Study Site 1
Buffalo, New York, United States

Regeneron Study Site 2
Buffalo, New York, United States

Regeneron Study Site
Jamaica, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
Rochester, New York, United States

Regeneron Study Site
Syracuse, New York, United States

Regeneron Study Site
West Islip, New York, United States

Regeneron Study Site
White Plains, New York, United States

Regeneron Study Site
Chapel Hill, North Carolina, United States

Regeneron Study Site
Greensboro, North Carolina, United States

Regeneron Study Site
Columbus, Ohio, United States

Regeneron Study Site
Columbus, Ohio, United States

Regeneron Study Site
Dayton, Ohio, United States

Regeneron Study Site
Portland, Oregon, United States

Regeneron Study Site
Portland, Oregon, United States

Regeneron Study Site
Philadelphia, Pennsylvania, United States

Regeneron Study Site
Providence, Rhode Island, United States

Regeneron Study Site
Providence, Rhode Island, United States

Regeneron Study Site
Sioux Falls, South Dakota, United States

Regeneron Study Site 1
Amarillo, Texas, United States

Regeneron Study Site 2
Amarillo, Texas, United States

Regeneron Study Site
Dallas, Texas, United States

Regeneron Study Site
Dallas, Texas, United States

Regeneron Study Site
Dallas, Texas, United States

Regeneron Study Site
Houston, Texas, United States

Regeneron Study Site
Houston, Texas, United States

Regeneron Study Site
Houston, Texas, United States

Regeneron Study Site
Lubbock, Texas, United States

Regeneron Study Site
Sugar Land, Texas, United States

Regeneron Study Site
Tyler, Texas, United States

Regeneron Study Site
Murray, Utah, United States

Regeneron Study Site
Salt Lake City, Utah, United States

Regeneron Study Site
Richmond, Virginia, United States

Regeneron Study Site
Everett, Washington, United States

Regeneron Study Site 1
Seattle, Washington, United States

Regeneron Study Site
Madison, Wisconsin, United States

Regeneron Study Site
Salvador, Bahia, Brazil

Regeneron Study Site
Fortaleza, Ceara, Brazil

Regeneron Study Site
Curitiba, Paraná, Brazil

Regeneron Study Site
Porto Alegre, Rio Grande Do Sul, Brazil

Regeneron Study Site
Passo Fundo, RS, Brazil

Regeneron Study Site
Chapeco, Santa Catarina, Brazil

Regeneron Study Site
Criciuma, Santa Catarina, Brazil

Regeneron Study Site
Botucatu, Sao Paolo, Brazil

Regeneron Study Site
Campinas, Sao Paolo, Brazil

Regeneron Study Site
São Paulo, Brazil

Regeneron Study Site
São Paulo, Brazil

Regeneron Study Site
São Paulo, Brazil

Regeneron Study Site 1
Las Condes, Santiago De Chile, Chile

Regeneron Study Site 2
Las Condes, Santiago De Chile, Chile

Regeneron Study Site
Vitacura, Santiago De Chile, Chile

Regeneron Study Site
Santiago de Chile, Chile

Regeneron Study Site
Guadalajara, Jalisco, Mexico

Regeneron Study Site
Monterrey, Nuevo Leon, Mexico

Regeneron Study Site
Culiacán, Sinaloa, Mexico

Regeneron Study Site
Culiacan, Mexico

Regeneron Study Site
Monterrey, Mexico

Regeneron Study Site 1
Mérida, Mexico

Regeneron Study Site 2
Mérida, Mexico

Regeneron Study Site
Veracruz, Mexico

Regeneron Study Site
Zapopan, Mexico

Regeneron Study Site
Chisinau, Moldova, Republic of

Regeneron Study Site
Bucuresti, Romania

Clinical Trial Management, Study Director
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals
NCT Number
Keywords
Coronavirus Disease 2019 (COVID-19)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Coronavirus
Acute Respiratory Distress Syndrome
MeSH Terms
COVID-19
Casirivimab and imdevimab drug combination