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

NCT04452318 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: R10933-10987-COV-20692020-003654-71
• Study Type: interventional
• Target: 3,303
• Locations: 3 countries
• Sites: 134

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

Conditions

Healthy Participants

Keywords

Asymptomatic; Individuals at risk of exposure to SARS-CoV-2; Household Contacts of a Person Infected with SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP

  Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.

  Up to 1 month

• Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP

  The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US).

  Up to 14 Days

• Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs

  Up to 8 months

Secondary Outcomes (53)

• Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP

  Up to 1 month

• Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP

  Up to 1 month

• Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP

  Up to 1 month

• Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP

  Up to 1 month

• Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP

  Up to 1 month

Study Arms (2)

REGN10933 + REGN10987

EXPERIMENTAL

Drug: REGN10933 + REGN10987

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

REGN10933 + REGN10987 DRUG

Subcutaneous (SC) or Intramuscular (IM) injections

Also known as: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™

REGN10933 + REGN10987

Placebo DRUG

SC or IM injections

Placebo

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• Participant anticipates living in the same household with the index case until study day 29
• 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
• Willing and able to comply with study visits and study-related procedures/assessments.
• Provide informed consent signed by study participant or legally acceptable representative.

You may not qualify if:

• History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening
• 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
• Active respiratory or non-respiratory symptoms consistent with COVID-19
• 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
• Nursing home resident
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (134)

Regeneron Study Site

Mesa, Arizona, 85210, United States

Location

Regeneron Study Site

Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85724, United States

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Regeneron Study Site

La Mesa, California, 91942, United States

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La Palma, California, 90623, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90035, United States

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Los Angeles, California, 90036, United States

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Los Angeles, California, 90095, United States

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Montclair, California, 91763, United States

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Northridge, California, 91324, United States

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Oxnard, California, 93030, United States

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Sacramento, California, 95817, United States

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Sacramento, California, 95821, United States

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San Diego, California, 92108, United States

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San Francisco, California, 94127, United States

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Stanford, California, 94305, United States

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Torrance, California, 90502, United States

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Torrance, California, 90505, United States

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Aurora, Colorado, 80045, United States

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Colorado Springs, Colorado, 80907, United States

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Washington D.C., District of Columbia, 20005, United States

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Boca Raton, Florida, 33487, United States

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Clearwater, Florida, 33756, United States

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Regeneron Study Site

DeLand, Florida, 32720, United States

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Ft. Pierce, Florida, 34982, United States

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Hialeah, Florida, 33010, United States

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Jacksonville, Florida, 32216, United States

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Lakeland, Florida, 33810, United States

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Loxahatchee Groves, Florida, 33470, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33012, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33184, United States

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Miami, Florida, 33186, United States

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Orlando, Florida, 32803, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33612, United States

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West Palm Beach, Florida, 33407, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30303, United States

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Atlanta, Georgia, 30322, United States

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Columbus, Georgia, 31904, United States

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Decatur, Georgia, 30030, United States

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Eatonton, Georgia, 31024, United States

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Marietta, Georgia, 30060, United States

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Sandy Springs, Georgia, 30328, United States

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Regeneron Study Site

Chicago, Illinois, 60607, United States

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Regeneron Study Site 2

Chicago, Illinois, 60612, United States

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Regeneron Study Site 3

Chicago, Illinois, 60612, United States

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Regeneron Study Site

Chicago, Illinois, 60612, United States

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Regeneron Study Site 1

Downers Grove, Illinois, 60515, United States

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Regeneron Study Site 2

Downers Grove, Illinois, 60515, United States

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Regeneron Study Site

Ames, Iowa, 50010-3014, United States

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Regeneron Study Site

Lake Charles, Louisiana, 70601, United States

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Marrero, Louisiana, 70072, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02118, United States

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Boston, Massachusetts, 02215, United States

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Detroit, Michigan, 48202, United States

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Royal Oak, Michigan, 48073, United States

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Minneapolis, Minnesota, 55455, United States

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Gulfport, Mississippi, 39503, United States

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Jackson, Mississippi, 39216, United States

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Hazelwood, Missouri, 63042, United States

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St Louis, Missouri, 63110, United States

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Las Vegas, Nevada, 89104, United States

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Las Vegas, Nevada, 89109, United States

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Morristown, New Jersey, 07960, United States

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Newark, New Jersey, 07103, United States

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Summit, New Jersey, 07901, United States

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Teaneck, New Jersey, 07666-4245, United States

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Buffalo, New York, 14203, United States

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Regeneron Study Site

New York, New York, 10016, United States

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New York, New York, 10027, United States

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New York, New York, 10029, United States

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New York, New York, 10032, United States

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Regeneron Study Site

New York, New York, 10037, United States

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Regeneron Study Site

New York, New York, 10065, United States

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Regeneron Study Site 1

The Bronx, New York, 10451, United States

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Regeneron Study Site 2

The Bronx, New York, 10451, United States

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Regeneron Study Site

The Bronx, New York, 10461, United States

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Regeneron Study Site

Chapel Hill, North Carolina, 27599, United States

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Regeneron Study Site

Charlotte, North Carolina, 28209, United States

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Fayetteville, North Carolina, 28304, United States

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Raleigh, North Carolina, 27612, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45267-0405, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43215, United States

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Dayton, Ohio, 45432, United States

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Danville, Pennsylvania, 17822, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19140, United States

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Wilkes-Barre, Pennsylvania, 18711, United States

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Regeneron Study Site

Providence, Rhode Island, 02906, United States

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Regeneron Study Site

Charleston, South Carolina, 29406, United States

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Charleston, South Carolina, 29425, United States

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Clinton, South Carolina, 29325, United States

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Gaffney, South Carolina, 29340, United States

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Sioux Falls, South Dakota, 57105, United States

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Chattanooga, Tennessee, 37421, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38103, United States

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Regeneron Study Site

Nashville, Tennessee, 37232, United States

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Regeneron Study Site

Bellaire, Texas, 77401, United States

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Regeneron Study Site

Corpus Christi, Texas, 78413, United States

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Regeneron Study Site

Dallas, Texas, 75224, United States

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Regeneron Study Site

Houston, Texas, 77008, United States

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Regeneron Study Site

Houston, Texas, 77024, United States

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Regeneron Study Site

Houston, Texas, 77026, United States

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Regeneron Study Site

Houston, Texas, 77057, United States

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Regeneron Study Site

Houston, Texas, 77093, United States

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Regeneron Study Site

Pearland, Texas, 77584, United States

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Regeneron Study Site

Red Oak, Texas, 75154, United States

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Regeneron Study Site

San Antonio, Texas, 78249, United States

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Tyler, Texas, 75701, United States

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Regeneron Study Site

Charlottesville, Virginia, 22903, United States

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Regeneron Study Site

Richmond, Virginia, 23298, United States

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Regeneron Study Site

Everett, Washington, 98201, United States

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Regeneron Study Site

Seattle, Washington, 98104, United States

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Regeneron Study Site

Yakima, Washington, 98902, United States

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Regeneron Study Site

Madison, Wisconsin, 53792, United States

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Regeneron Study Site

Chisinau, MD-2025, Moldova

Location

Regeneron Study Site

Bucharest, 021105, Romania

Location

Related Publications (8)

• 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.

  PMID: 37330602 DERIVED

• 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.

  PMID: 35803290 DERIVED

• 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.

  PMID: 35713300 DERIVED

• 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.

  PMID: 35029629 DERIVED

• 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.

  PMID: 34473343 DERIVED

• 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.

  PMID: 34347950 DERIVED

• 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.

  PMID: 34159344 DERIVED

• 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.

  PMID: 34159343 DERIVED

MeSH Terms

Interventions

casirivimab; imdevimab; casirivimab and imdevimab drug combination

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

8447346643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: July 13, 2020
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: May 15, 2023
• Results First Posted: May 15, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

US (132); MO (1); RO (1)