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

April 20, 2023 updated by: Regeneron Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

3303

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD-2025
        • Regeneron Study Site
  • Romania
      • Bucharest, Romania, 021105
        • Regeneron Study Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Regeneron Study Site
      • Tucson, Arizona, United States, 85712
        • Regeneron Study Site
      • Tucson, Arizona, United States, 85724
        • Regeneron Study Site
    • California
      • La Mesa, California, United States, 91942
        • Regeneron Study Site
      • La Palma, California, United States, 90623
        • Regeneron Study Site
      • Long Beach, California, United States, 90806
        • Regeneron Study Site
      • Los Angeles, California, United States, 90036
        • Regeneron Study Site
      • Los Angeles, California, United States, 90095
        • Regeneron Study Site
      • Los Angeles, California, United States, 90035
        • Regeneron Study Site
      • Montclair, California, United States, 91763
        • Regeneron Study Site
      • Northridge, California, United States, 91324
        • Regeneron Study Site
      • Oxnard, California, United States, 93030
        • Regeneron Study Site
      • Sacramento, California, United States, 95817
        • Regeneron Study Site
      • Sacramento, California, United States, 95821
        • Regeneron Study Site
      • San Diego, California, United States, 92108
        • Regeneron Study Site
      • San Francisco, California, United States, 94127
        • Regeneron Study Site
      • Stanford, California, United States, 94305
        • Regeneron Study Site
      • Torrance, California, United States, 90502
        • Regeneron Study Site
      • Torrance, California, United States, 90505
        • Regeneron Study Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Regeneron Study Site
      • Colorado Springs, Colorado, United States, 80907
        • Regeneron Study Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20005
        • Regeneron Study Site
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Regeneron Study Site
      • Clearwater, Florida, United States, 33756
        • Regeneron Study Site
      • DeLand, Florida, United States, 32720
        • Regeneron Study Site
      • Fort Pierce, Florida, United States, 34982
        • Regeneron Study Site
      • Hialeah, Florida, United States, 33010
        • Regeneron Study Site
      • Jacksonville, Florida, United States, 32216
        • Regeneron Study Site
      • Lakeland, Florida, United States, 33810
        • Regeneron Study Site
      • Loxahatchee Groves, Florida, United States, 33470
        • Regeneron Study Site
      • Maitland, Florida, United States, 32751
        • Regeneron Study Site
      • Miami, Florida, United States, 33136
        • Regeneron Study Site
      • Miami, Florida, United States, 33126
        • Regeneron Study Site
      • Miami, Florida, United States, 33012
        • Regeneron Study Site
      • Miami, Florida, United States, 33144
        • Regeneron Study Site
      • Miami, Florida, United States, 33184
        • Regeneron Study Site
      • Miami, Florida, United States, 33186
        • Regeneron Study Site
      • Miami, Florida, United States, 33125
        • Regeneron Study Site
      • Orlando, Florida, United States, 32803
        • Regeneron Study Site
      • Sarasota, Florida, United States, 34239
        • Regeneron Study Site
      • Tampa, Florida, United States, 33612
        • Regeneron Study Site
      • West Palm Beach, Florida, United States, 33407
        • Regeneron Study Site
      • Winter Park, Florida, United States, 32789
        • Regeneron Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Regeneron Study Site
      • Atlanta, Georgia, United States, 30303
        • Regeneron Study Site
      • Columbus, Georgia, United States, 31904
        • Regeneron Study Site
      • Decatur, Georgia, United States, 30030
        • Regeneron Study Site
      • Eatonton, Georgia, United States, 31024
        • Regeneron Study Site
      • Marietta, Georgia, United States, 30060
        • Regeneron Study Site
      • Sandy Springs, Georgia, United States, 30328
        • Regeneron Study Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Regeneron Study Site
      • Chicago, Illinois, United States, 60607
        • Regeneron Study Site
      • Chicago, Illinois, United States, 60612
        • Regeneron Study Site 2
      • Chicago, Illinois, United States, 60612
        • Regeneron Study Site 3
      • Downers Grove, Illinois, United States, 60515
        • Regeneron Study Site 1
      • Downers Grove, Illinois, United States, 60515
        • Regeneron Study Site 2
    • Iowa
      • Ames, Iowa, United States, 50010-3014
        • Regeneron Study Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Regeneron Study Site
      • Marrero, Louisiana, United States, 70072
        • Regeneron Study Site
      • Metairie, Louisiana, United States, 70006
        • Regeneron Study Site
      • New Orleans, Louisiana, United States, 70112
        • Regeneron Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Regeneron Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Regeneron Study Site
      • Boston, Massachusetts, United States, 02111
        • Regeneron Study Site
      • Boston, Massachusetts, United States, 02115
        • Regeneron Study Site
      • Boston, Massachusetts, United States, 02118
        • Regeneron Study Site
      • Boston, Massachusetts, United States, 02215
        • Regeneron Study Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Regeneron Study Site
      • Royal Oak, Michigan, United States, 48073
        • Regeneron Study Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Regeneron Study Site
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Regeneron Study Site
      • Jackson, Mississippi, United States, 39216
        • Regeneron Study Site
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Regeneron Study Site
      • Saint Louis, Missouri, United States, 63110
        • Regeneron Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Regeneron Study Site
      • Las Vegas, Nevada, United States, 89104
        • Regeneron Study Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Regeneron Study Site
      • Newark, New Jersey, United States, 07103
        • Regeneron Study Site
      • Summit, New Jersey, United States, 07901
        • Regeneron Study Site
      • Teaneck, New Jersey, United States, 07666-4245
        • Regeneron Study Site
    • New York
      • Bronx, New York, United States, 10461
        • Regeneron Study Site
      • Bronx, New York, United States, 10451
        • Regeneron Study Site 1
      • Bronx, New York, United States, 10451
        • Regeneron Study Site 2
      • Buffalo, New York, United States, 14203
        • Regeneron Study Site
      • New York, New York, United States, 10029
        • Regeneron Study Site
      • New York, New York, United States, 10032
        • Regeneron Study Site
      • New York, New York, United States, 10016
        • Regeneron Study Site
      • New York, New York, United States, 10065
        • Regeneron Study Site
      • New York, New York, United States, 10037
        • Regeneron Study Site
      • New York, New York, United States, 10027
        • Regeneron Study Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Regeneron Study Site
      • Charlotte, North Carolina, United States, 28209
        • Regeneron Study Site
      • Fayetteville, North Carolina, United States, 28304
        • Regeneron Study Site
      • Raleigh, North Carolina, United States, 27612
        • Regeneron Study Site
      • Wilmington, North Carolina, United States, 28401
        • Regeneron Study Site
      • Winston-Salem, North Carolina, United States, 27103
        • Regeneron Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0405
        • Regeneron Study Site
      • Columbus, Ohio, United States, 43215
        • Regeneron Study Site
      • Columbus, Ohio, United States, 43210
        • Regeneron Study Site
      • Dayton, Ohio, United States, 45432
        • Regeneron Study Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Regeneron Study Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Regeneron Study Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Regeneron Study Site
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Regeneron Study Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Regeneron Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Regeneron Study Site
      • Charleston, South Carolina, United States, 29406
        • Regeneron Study Site
      • Clinton, South Carolina, United States, 29325
        • Regeneron Study Site
      • Gaffney, South Carolina, United States, 29340
        • Regeneron Study Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Regeneron Study Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Regeneron Study Site
      • Knoxville, Tennessee, United States, 37920
        • Regeneron Study Site
      • Memphis, Tennessee, United States, 38103
        • Regeneron Study Site
      • Nashville, Tennessee, United States, 37232
        • Regeneron Study Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Regeneron Study Site
      • Corpus Christi, Texas, United States, 78413
        • Regeneron Study Site
      • Dallas, Texas, United States, 75224
        • Regeneron Study Site
      • Houston, Texas, United States, 77008
        • Regeneron Study Site
      • Houston, Texas, United States, 77057
        • Regeneron Study Site
      • Houston, Texas, United States, 77093
        • Regeneron Study Site
      • Houston, Texas, United States, 77024
        • Regeneron Study Site
      • Houston, Texas, United States, 77026
        • Regeneron Study Site
      • Pearland, Texas, United States, 77584
        • Regeneron Study Site
      • Red Oak, Texas, United States, 75154
        • Regeneron Study Site
      • San Antonio, Texas, United States, 78249
        • Regeneron Study Site
      • Tyler, Texas, United States, 75701
        • Regeneron Study Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Regeneron Study Site
      • Richmond, Virginia, United States, 23298
        • Regeneron Study Site
    • Washington
      • Everett, Washington, United States, 98201
        • Regeneron Study Site
      • Seattle, Washington, United States, 98104
        • Regeneron Study Site
      • Yakima, Washington, United States, 98902
        • Regeneron Study Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Regeneron Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
SC or IM injections
Experimental: REGN10933 + REGN10987
Drug: REGN10933 + REGN10987
Subcutaneous (SC) or Intramuscular (IM) injections
Other Names:
  • REGN-COV2
  • Casirivimab
  • Imdevimab
  • REGEN-COV™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP
Time Frame: Up to 1 month
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
Time Frame: Up to 14 Days
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
Time Frame: Up to 8 months
Up to 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP
Time Frame: Up to 1 month
High viral load (> 4 log 10 copies/ml)
Up to 1 month
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP
Time Frame: Up to 1 month
High viral load (> 4 log 10 copies/ml)
Up to 1 month
Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
Time Frame: Up to 1 month
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
Time Frame: Up to 1 month
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 1 month
Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
Time Frame: Up to 1 month
Symptomatic SARS-CoV-2 infection (CDC definition) 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 A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
Time Frame: Up to 1 month
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 1 month
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
Time Frame: Week 1, Week 2, Week 3, Week 4
Week 1, Week 2, Week 3, Week 4
Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP
Time Frame: Week 1, Week 2, Week 3, Week 4
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)
Week 1, Week 2, Week 3, Week 4
Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
Time Frame: Up to 1 month
Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.
Up to 1 month
Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
Time Frame: Up to 14 Days
The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP
Up to 14 Days
Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
Time Frame: Up to Day 29
Up to Day 29
Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
Time Frame: Up to 1 month
Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)
Up to 1 month
Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
Time Frame: Up to 8 months
Up to 8 months
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Time Frame: Up to Day 29
Up to Day 29
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Time Frame: Day 30 Up to Day 225 (Approximately 8 months)
Day 30 Up to Day 225 (Approximately 8 months)
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Time Frame: Up to Day 29
Up to Day 29
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Time Frame: Day 30 Up to Day 225 (Approximately 8 months)
Day 30 Up to Day 225 (Approximately 8 months)
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Time Frame: Up to Day 29
Up to Day 29
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Time Frame: Day 30 Up to Day 225 (Approximately 8 months)
Day 30 Up to Day 225 (Approximately 8 months)
Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
Time Frame: Up to 14 Days
Up to 14 Days
Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
Time Frame: Up to 1 month
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 1 month
Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
Time Frame: Up to 14 Days
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 B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
Time Frame: Up to 14 Days
Up to 14 Days
Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
Time Frame: Up to 14 Days
Up to 14 Days
Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples
Time Frame: Up to day 8 visit
Up to day 8 visit
Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples
Time Frame: Up to day 15 visit
Up to day 15 visit
Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit
Time Frame: Day 22
Day 22
Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test
Time Frame: Up to 14 Days
Up to 14 Days
Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
Time Frame: Up to 14 Days
Up to 14 Days
Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
Time Frame: Up to 1 month
Up to 1 month
Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
Time Frame: Up to 1 month
Up to 1 month
Concentrations of REGN10987 in Serum Over Time (Cohort A)
Time Frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Concentrations of REGN10987 in Serum Over Time (Cohort B)
Time Frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Concentrations of REGN10933 in Serum Over Time (Cohort A)
Time Frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Concentrations of REGN10933 in Serum Over Time (Cohort B)
Time Frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
Time Frame: Up to 8 months
Up to 8 months
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
Time Frame: Up to 8 months
Up to 8 months
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
Time Frame: Up to 8 months
(TE&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Up to 8 months
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
Time Frame: Up to 8 Months
(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Up to 8 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Actual)

October 4, 2021

Study Completion (Actual)

October 4, 2021

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R10933-10987-COV-2069
  • 2020-003654-71 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing 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.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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