COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2

Brief Summary

Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term) Cohort B and Cohort B1 • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo

Detailed Description

Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at
baseline

Cohort A1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline

Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at
baseline

Cohort B1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline

Status

Completed

Conditions

Healthy Participants

Interventions

Drug: REGN10933 + REGN10987

Subcutaneous (SC) or Intramuscular (IM) injections
Other Name: Array

Drug: Placebo

SC or IM injections

Eligibility Criteria

Key Inclusion Criteria:

1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of
informed consent or adolescent participants ≥12 to <18 years of age, or pediatric
participants <12 years of age at the signing of the assent (parent/guardian sign the
informed consent)

2. Asymptomatic household contact with exposure to an individual with a diagnosis of
SARS-CoV-2 infection (index case). To be included in the study, participants must be
randomized within 96 hours of collection of the index cases' positive SARS-COV-2
diagnostic test sample

3. Participant anticipates living in the same household with the index case until study
day 29

4. Is judged by the investigator to be in good health based on medical history and
physical examination at screening/baseline, including participants who are healthy or
have a chronic, stable medical condition

5. Willing and able to comply with study visits and study-related procedures/assessments.

6. Provide informed consent signed by study participant or legally acceptable
representative.

Key Exclusion Criteria:

1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test
at any time before the screening

2. Participant has lived with individuals who have had previous SARS-CoV-2 infection or
currently lives with individuals who have SARS-CoV-2 infection, with the exception of
the index case(s), the first individual(s) known to be infected in the household

3. Active respiratory or non-respiratory symptoms consistent with COVID-19

4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the
opinion of the investigator, within the prior 6 months to screening

5. Nursing home resident

6. Any physical examination findings, and/or history of any illness, concomitant
medications or recent live vaccines that, in the opinion of the study investigator,
might confound the results of the study or pose an additional risk to the participant
by their participation in the study

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Eligibility Gender

All

Eligibility Age

Minimum: 1 Day ~ Maximum: N/A

Countries

Moldova, Republic of

Romania

United States

Locations

Regeneron Study Site
Mesa, Arizona, United States

Regeneron Study Site
Tucson, Arizona, United States

Regeneron Study Site
La Mesa, California, United States

Regeneron Study Site
La Palma, California, United States

Regeneron Study Site
Long Beach, California, United States

Regeneron Study Site
Los Angeles, California, United States

Regeneron Study Site
Montclair, California, United States

Regeneron Study Site
Northridge, California, United States

Regeneron Study Site
Oxnard, California, United States

Regeneron Study Site
Sacramento, California, United States

Regeneron Study Site
San Diego, California, United States

Regeneron Study Site
San Francisco, California, United States

Regeneron Study Site
Stanford, California, United States

Regeneron Study Site
Torrance, 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
Clearwater, 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
Jacksonville, Florida, United States

Regeneron Study Site
Lakeland, 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
Orlando, 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 Park, Florida, United States

Regeneron Study Site
Atlanta, Georgia, United States

Regeneron Study Site
Columbus, Georgia, United States

Regeneron Study Site
Decatur, Georgia, United States

Regeneron Study Site
Eatonton, Georgia, United States

Regeneron Study Site
Marietta, Georgia, United States

Regeneron Study Site
Sandy Springs, Georgia, United States

Regeneron Study Site
Chicago, Illinois, United States

Regeneron Study Site 2
Chicago, Illinois, United States

Regeneron Study Site 3
Chicago, Illinois, 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
Ames, Iowa, United States

Regeneron Study Site
Lake Charles, Louisiana, United States

Regeneron Study Site
Marrero, Louisiana, United States

Regeneron Study Site
Metairie, 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
Detroit, Michigan, United States

Regeneron Study Site
Royal Oak, Michigan, United States

Regeneron Study Site
Minneapolis, Minnesota, United States

Regeneron Study Site
Gulfport, Mississippi, United States

Regeneron Study Site
Jackson, Mississippi, United States

Regeneron Study Site
Hazelwood, Missouri, United States

Regeneron Study Site
Saint Louis, Missouri, United States

Regeneron Study Site
Las Vegas, Nevada, United States

Regeneron Study Site
Morristown, New Jersey, United States

Regeneron Study Site
Newark, New Jersey, United States

Regeneron Study Site
Summit, New Jersey, United States

Regeneron Study Site
Teaneck, New Jersey, United States

Regeneron Study Site 1
Bronx, New York, United States

Regeneron Study Site 2
Bronx, New York, United States

Regeneron Study Site
Bronx, New York, United States

Regeneron Study Site
Buffalo, New York, United States

Regeneron Study Site
New York, New York, United States

Regeneron Study Site
Chapel Hill, North Carolina, United States

Regeneron Study Site
Charlotte, North Carolina, United States

Regeneron Study Site
Fayetteville, North Carolina, United States

Regeneron Study Site
Raleigh, North Carolina, United States

Regeneron Study Site
Wilmington, North Carolina, United States

Regeneron Study Site
Winston-Salem, North Carolina, United States

Regeneron Study Site
Cincinnati, Ohio, United States

Regeneron Study Site
Columbus, Ohio, United States

Regeneron Study Site
Dayton, Ohio, United States

Regeneron Study Site
Danville, Pennsylvania, United States

Regeneron Study Site
Philadelphia, Pennsylvania, United States

Regeneron Study Site
Wilkes-Barre, 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
Gaffney, South Carolina, United States

Regeneron Study Site
Sioux Falls, South Dakota, United States

Regeneron Study Site
Chattanooga, Tennessee, United States

Regeneron Study Site
Knoxville, Tennessee, United States

Regeneron Study Site
Memphis, Tennessee, United States

Regeneron Study Site
Nashville, Tennessee, United States

Regeneron Study Site
Bellaire, Texas, United States

Regeneron Study Site
Corpus Christi, Texas, United States

Regeneron Study Site
Dallas, 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
Tyler, Texas, United States

Regeneron Study Site
Charlottesville, Virginia, United States

Regeneron Study Site
Richmond, Virginia, United States

Regeneron Study Site
Everett, Washington, United States

Regeneron Study Site
Seattle, Washington, United States

Regeneron Study Site
Yakima, Washington, United States

Regeneron Study Site
Madison, Wisconsin, United States

Regeneron Study Site
Chisinau, Moldova, Republic of

Regeneron Study Site
Bucharest, Romania

Investigators

Clinical Trial Management, Study Director
Regeneron Pharmaceuticals

NCT Number

NCT04452318

Keywords

asymptomatic

Individuals at risk of exposure to SARS-CoV-2

Household Contacts of a Person Infected with SARS-CoV-2

MeSH Terms

COVID-19

Casirivimab and imdevimab drug combination

Regeneron Pharmaceuticals

COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2

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