Phase 1 - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 3 - Cohort 1 (≥18 Years Old, Not Pregnant at Randomization) • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death - Cohort 2 (
Drug: casirivimab+imdevimab combination therapy
Administered intravenously (IV) single dose
Other Name: Array
Key Inclusion Criteria:
- Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to
randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular
diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal,
oropharyngeal [OP], or saliva)
- Has symptoms consistent with COVID-19, as determined by the investigator, with onset
≤7 days before randomization
- Maintains O2 saturation ≥93% on room air
- Is able to understand and complete study-related questionnaires (patients aged ≥12
years only)
Key Exclusion Criteria:
- Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized
(inpatient) for any reason at randomization
- Has participated, or is participating, in a clinical research study evaluating
COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or
intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the
investigational product (whichever is longer) prior to the screening visit
- Prior, current, or planned future use of any of the following treatments: COVID-19
convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any
indication), systemic corticosteroids (any indication), or COVID-19 treatments
(authorized, approved, or investigational)
- Prior use (prior to randomization), current use (at randomization) or planned use
(within 90 days of study drug administration or per current CDC recommendations, as
applicable) of any authorized or approved vaccine for COVID-19
- Has participated, is participating or plans to participate in a clinical research
study evaluation any authorized, approved or investigational vaccine for COVID-19
NOTE: Other Protocol defined Inclusion/Exclusion criteria apply
Regeneron Study Site
Mesa, Arizona, United States
Regeneron Study Site
Tucson, Arizona, United States
Regeneron Study Site
Tucson, Arizona, United States
Regeneron Study Site
Canoga Park, California, United States
Regeneron Study Site
La Mesa, California, United States
Regeneron Study Site
La Palma, California, United States
Regeneron Study Site 1
Long Beach, California, United States
Regeneron Study Site 2
Long Beach, California, United States
Regeneron Study Site 3
Long Beach, California, United States
Regeneron Study Site
Los Angeles, California, United States
Regeneron Study Site
Montclair, California, United States
Regeneron Study Site
Rolling Hills Estates, California, United States
Regeneron Study Site
Sacramento, California, United States
Regeneron Study Site
San Francisco, California, United States
Regeneron Study Site
Santa Monica, California, United States
Regeneron Study Site
Stanford, California, United States
Regeneron Study Site
Aurora, Colorado, United States
Regeneron Study Site
Colorado Springs, Colorado, United States
Regeneron Study Site
Washington, District of Columbia, United States
Regeneron Study Site
Boca Raton, Florida, United States
Regeneron Study Site
DeLand, Florida, United States
Regeneron Study Site
Fort Pierce, Florida, United States
Regeneron Study Site
Hialeah, Florida, United States
Regeneron Study Site
Loxahatchee Groves, Florida, United States
Regeneron Study Site
Maitland, Florida, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site 1
Miami, Florida, United States
Regeneron Study Site 2
Miami, Florida, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
Saint Petersburg, Florida, United States
Regeneron Study Site
Sarasota, Florida, United States
Regeneron Study Site
Tampa, Florida, United States
Regeneron Study Site
West Palm Beach, Florida, United States
Regeneron Study Site
Winter Haven, Florida, United States
Regeneron Study Site
Winter Park, Florida, United States
Regeneron Study Site
Atlanta, Georgia, United States
Regeneron Study Site
Atlanta, Georgia, United States
Regeneron Study Site
Augusta, Georgia, United States
Regeneron Study Site
Columbus, Georgia, United States
Regeneron Study Site
Marietta, Georgia, United States
Regeneron Study Site
Chicago, Illinois, United States
Regeneron Study Site 1
Downers Grove, Illinois, United States
Regeneron Study Site 2
Downers Grove, Illinois, United States
Regeneron Study Site
Downers Grove, Illinois, United States
Regeneron Study Site
Ames, Iowa, United States
Regeneron Study Site
Iowa City, Iowa, United States
Regeneron Study Site
Lake Charles, Louisiana, United States
Regeneron Study Site
Marrero, Louisiana, United States
Regeneron Study Site
New Orleans, Louisiana, United States
Regeneron Study Site
Shreveport, Louisiana, United States
Regeneron Study Site
Baltimore, Maryland, United States
Regeneron Study Site
Royal Oak, Michigan, United States
Regeneron Study Site
Jackson, Mississippi, United States
Regeneron Study Site
Las Vegas, Nevada, United States
Regeneron Study Site
Ridgewood, New Jersey, United States
Regeneron Study Site
Teaneck, New Jersey, United States
Regeneron Study Site
Santa Fe, New Mexico, United States
Regeneron Study Site
Bronx, New York, United States
Regeneron Study Site
Bronx, New York, United States
Regeneron Study Site
Jamaica, New York, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
Charlotte, North Carolina, United States
Regeneron Study Site
Durham, North Carolina, United States
Regeneron Study Site
Wilmington, North Carolina, United States
Regeneron Study Site
Columbus, Ohio, United States
Regeneron Study Site
Dayton, Ohio, United States
Regeneron Study Site
Dayton, Ohio, United States
Regeneron Study Site
Philadelphia, Pennsylvania, United States
Regeneron Study Site
Providence, Rhode Island, United States
Regeneron Study Site
Charleston, South Carolina, United States
Regeneron Study Site
Clinton, South Carolina, United States
Regeneron Study Site
Sioux Falls, South Dakota, United States
Regeneron Study Site 2
Memphis, Tennessee, United States
Regeneron Study Site
Memphis, Tennessee, United States
Regeneron Study Site
Amarillo, Texas, United States
Regeneron Study Site
Corpus Christi, Texas, United States
Regeneron Study Site
Dallas, Texas, United States
Regeneron Study Site
Dallas, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Pearland, Texas, United States
Regeneron Study Site
Red Oak, Texas, United States
Regeneron Study Site
San Antonio, Texas, United States
Regeneron Study Site
San Antonio, Texas, United States
Regeneron Study Site
San Antonio, Texas, United States
Regeneron Study Site
Tyler, Texas, United States
Regeneron Study Site
Falls Church, Virginia, United States
Regeneron Study Site
Everett, Washington, United States
Regeneron Study Site
Seattle, Washington, United States
Regeneron Study Site
Seattle, Washington, United States
Regeneron Study Site
Madison, Wisconsin, United States
Regeneron Study Site
Guadalajara, Jalisco, Mexico
Regeneron Study Site
Guadalajara, Jalisco, Mexico
Regeneron Study Site
Zapopan, Jalisco, Mexico
Regeneron Study Site
Monterrey, Nuevo Leon, Mexico
Regeneron Study Site
Monterrey, Nuevo León, Mexico
Regeneron Study Site
Merida, Yucatan, Mexico
Regeneron Study Site
Chihuahua, Mexico
Regeneron Study Site
Ciudad de Mexico, Mexico
Regeneron Study Site
Durango, Mexico
Regeneron Study Site
Mérida, Mexico
Regeneron Study Site
Veracruz, Mexico
Regeneron Study Site
Bucuresti, Romania
Clinical Trial Management, Study Director
Regeneron Pharmaceuticals