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

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 (

Terminated
COVID-19

Drug: casirivimab+imdevimab combination therapy

Administered intravenously (IV) single dose
Other Name: Array

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Mexico
Romania
United States
Locations

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

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