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
Drug: REGN10933+REGN10987 combination therapy
Administered intravenously (IV) single dose
Other Name: Array
Drug: Placebo
Placebo IV Single Dose
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
Regeneron Study Site
Birmingham, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Long Beach, California, United States
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Mission Hills, California, United States
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Sacramento, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Boca Raton, Florida, United States
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Fort Pierce, Florida, United States
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Gainesville, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Glenview, Illinois, United States
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Urbana, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Royal Oak, Michigan, United States
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Rochester, Minnesota, United States
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Chesterfield, Missouri, United States
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Saint Louis, Missouri, United States
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Saint Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Englewood, New Jersey, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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Neptune, New Jersey, United States
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Pennington, New Jersey, United States
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Summit, New Jersey, United States
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Teaneck, New Jersey, United States
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Albuquerque, New Mexico, United States
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Bronx, New York, United States
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Bronx, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Buffalo, New York, United States
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Buffalo, New York, United States
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Jamaica, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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West Islip, New York, United States
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White Plains, New York, United States
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Chapel Hill, North Carolina, United States
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Greensboro, North Carolina, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Sioux Falls, South Dakota, United States
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Amarillo, Texas, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Sugar Land, Texas, United States
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Tyler, Texas, United States
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Murray, Utah, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Everett, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Salvador, Bahia, Brazil
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Fortaleza, Ceara, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil
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Passo Fundo, RS, Brazil
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Chapeco, Santa Catarina, Brazil
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Criciuma, Santa Catarina, Brazil
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Botucatu, Sao Paolo, Brazil
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Campinas, Sao Paolo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Las Condes, Santiago De Chile, Chile
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Las Condes, Santiago De Chile, Chile
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Vitacura, Santiago De Chile, Chile
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Santiago de Chile, Chile
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo Leon, Mexico
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Culiacán, Sinaloa, Mexico
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Culiacan, Mexico
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Monterrey, Mexico
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Mérida, Mexico
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Mérida, Mexico
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Veracruz, Mexico
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Zapopan, Mexico
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Chisinau, Moldova, Republic of
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Bucuresti, Romania
Clinical Trial Management, Study Director
Regeneron Pharmaceuticals