The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo. The secondary objectives of the study are: - To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To assess the concentrations of REGN10933 and REGN10987 in serum over time - To assess the immunogenicity of REGN10933 and REGN10987
Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Name: Array
Drug: Placebo
Administered IV or SC single dose to match
Key Inclusion Criteria:
- Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to
randomization, as defined by the protocol
- Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by
the investigator) with onset ≤7 days before randomization, and meets all of the
following 8 criteria:
1. Age ≤50
2. No obesity, with obesity defined as BMI ≥30 kg/m2
3. Does not have cardiovascular disease or hypertension
4. Does not have chronic lung disease or asthma
5. Does not have type 1 or type 2 diabetes mellitus
6. Does not have chronic kidney disease, with or without dialysis
7. Does not have chronic liver disease
8. Is not pregnant or
- Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by
the investigator) occurring at any time <2 months prior to randomization
- Maintains O2 saturation ≥93% on room air
Key Exclusion Criteria:
- Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized
(inpatient) for any reason at randomization
- Has a known positive SARS-CoV-2 serologic test
- Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected
>72 hours prior to randomization
- Is immunosuppressed, based on investigator's assessment
- Has participated, or is participating, in a clinical research study evaluating
COVID-19 convalescent plasma, mAbs against SARS-CoV-2, 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 time period given per CDC guidance but no sooner than 22 days of study drug
administration) of any authorized or approved vaccine for COVID-19
- Has known active infection with influenza or other non-SARS-CoV-2 respiratory
pathogen, confirmed by a diagnostic test
- Has participated, is participating, or plans to participate in a clinical research
study evaluating any authorized, approved, or investigational vaccine for COVID-19
NOTE: Other protocol defined inclusion/exclusion criteria apply
Regeneron Study Site
Mesa, Arizona, United States
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Tucson, Arizona, United States
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Canoga Park, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Rolling Hills Estates, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Colorado Springs, Colorado, United States
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Washington, District of Columbia, United States
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DeLand, Florida, United States
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Fort Pierce, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Saint Petersburg, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Winter Haven, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Downers Grove, Illinois, United States
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Ames, Iowa, United States
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Iowa City, Iowa, United States
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Lake Charles, Louisiana, United States
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Marrero, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Las Vegas, Nevada, United States
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Teaneck, New Jersey, United States
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Bronx, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Wilmington, North Carolina, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Clinton, South Carolina, United States
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Amarillo, Texas, United States
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Corpus Christi, 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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Houston, Texas, United States
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Pearland, Texas, United States
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Red Oak, Texas, United States
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San Antonio, Texas, United States
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Splendora, Texas, United States
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Tyler, Texas, United States
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Falls Church, Virginia, United States
Clinical Trial Management, Study Director
Regeneron Pharmaceuticals