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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 RT-PCR Assay

NCT ID: NCT04452318

Last Updated: 2023-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2021-10-04

Brief Summary

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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

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Detailed Description

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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

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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REGN10933 + REGN10987

Group Type EXPERIMENTAL

REGN10933 + REGN10987

Intervention Type DRUG

Subcutaneous (SC) or Intramuscular (IM) injections

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC or IM injections

Interventions

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REGN10933 + REGN10987

Subcutaneous (SC) or Intramuscular (IM) injections

Intervention Type DRUG

Placebo

SC or IM injections

Intervention Type DRUG

Other Intervention Names

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REGN-COV2 Casirivimab Imdevimab REGEN-COV™

Eligibility Criteria

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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.

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
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Mesa, Arizona, United States

Site Status

Regeneron Study Site

Tucson, Arizona, United States

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Regeneron Study Site

Tucson, Arizona, United States

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La Mesa, California, United States

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La Palma, 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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Los Angeles, California, United States

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Los Angeles, California, United States

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Montclair, California, United States

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Northridge, California, United States

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Oxnard, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Ft. Pierce, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Loxahatchee Groves, 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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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Sarasota, 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 Park, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Eatonton, Georgia, United States

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Marietta, Georgia, United States

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Sandy Springs, Georgia, United States

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Chicago, Illinois, United States

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Regeneron Study Site 2

Chicago, Illinois, United States

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Regeneron Study Site 3

Chicago, Illinois, United States

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Chicago, Illinois, United States

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Regeneron Study Site 1

Downers Grove, Illinois, United States

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Regeneron Study Site 2

Downers Grove, Illinois, United States

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Regeneron Study Site

Ames, Iowa, United States

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Lake Charles, Louisiana, United States

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Marrero, Louisiana, United States

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Metairie, 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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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Royal Oak, Michigan, United States

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Minneapolis, Minnesota, United States

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Gulfport, Mississippi, United States

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Jackson, Mississippi, United States

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Hazelwood, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Morristown, New Jersey, United States

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Newark, 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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Buffalo, 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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Regeneron Study Site 1

The Bronx, New York, United States

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Regeneron Study Site 2

The Bronx, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Fayetteville, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, 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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Danville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Clinton, South Carolina, United States

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Gaffney, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Bellaire, Texas, United States

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Corpus Christi, 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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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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Tyler, Texas, United States

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Charlottesville, Virginia, 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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Yakima, Washington, United States

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Regeneron Study Site

Madison, Wisconsin, United States

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Regeneron Study Site

Chisinau, , Moldova

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Regeneron Study Site

Bucharest, , Romania

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Countries

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United States Moldova Romania

References

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Follmann D, O'Brien MP, Fintzi J, Fay MP, Montefiori D, Mateja A, Herman GA, Hooper AT, Turner KC, Chan KC, Forleo-Neto E, Isa F, Baden LR, El Sahly HM, Janes H, Doria-Rose N, Miller J, Zhou H, Dang W, Benkeser D, Fong Y, Gilbert PB, Marovich M, Cohen MS. Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration. Nat Commun. 2023 Jun 17;14(1):3605. doi: 10.1038/s41467-023-39292-w.

Reference Type DERIVED
PMID: 37330602 (View on PubMed)

Herman GA, O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Musser BJ, Davis JD, Turner KC, Mahmood A, Hooper AT, Hamilton JD, Parrino J, Subramaniam D, Baum A, Kyratsous CA, DiCioccio AT, Stahl N, Braunstein N, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2022 Oct;22(10):1444-1454. doi: 10.1016/S1473-3099(22)00416-9. Epub 2022 Jul 5.

Reference Type DERIVED
PMID: 35803290 (View on PubMed)

Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

Reference Type DERIVED
PMID: 35713300 (View on PubMed)

O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Musser BJ, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Brown ER, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):432-441. doi: 10.1001/jama.2021.24939.

Reference Type DERIVED
PMID: 35029629 (View on PubMed)

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; Covid-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. N Engl J Med. 2021 Sep 23;385(13):1184-1195. doi: 10.1056/NEJMoa2109682. Epub 2021 Aug 4.

Reference Type DERIVED
PMID: 34347950 (View on PubMed)

O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM. Subcutaneous REGEN-COV Antibody Combination for Covid-19 Prevention. medRxiv [Preprint]. 2021 Jun 17:2021.06.14.21258567. doi: 10.1101/2021.06.14.21258567.

Reference Type DERIVED
PMID: 34159344 (View on PubMed)

O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Musser BJ, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Brown ER, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV Antibody Combination in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. medRxiv [Preprint]. 2021 Sep 18:2021.06.14.21258569. doi: 10.1101/2021.06.14.21258569.

Reference Type DERIVED
PMID: 34159343 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R10933-10987-COV-2069

Identifier Type: -

Identifier Source: org_study_id

2020-003654-71

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

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