Healthy ParticipantsPhase 3NCT04452318
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
A Phase 3 study testing REGN10933 + REGN10987 in people with Healthy Participants, run by Regeneron Pharmaceuticals at 134 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- REGN10933 + REGN10987
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,303 participants
- Where
- 134 sitesin 3 countries
- Study dates
- 13 Jul 2020to 4 Oct 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
134 sites in 3 countries.
134 sites in 3 countries
United States132 sites
Regeneron Study Site
Ames, Iowa, 50010-3014
Regeneron Study Site
Atlanta, Georgia, 30303
Regeneron Study Site
Atlanta, Georgia, 30322
Regeneron Study Site
Aurora, Colorado, 80045
Regeneron Study Site
Baltimore, Maryland, 21201
Regeneron Study Site
Bellaire, Texas, 77401
Regeneron Study Site
Boca Raton, Florida, 33487
Regeneron Study Site
Boston, Massachusetts, 02111
Regeneron Study Site
Boston, Massachusetts, 02114
Regeneron Study Site
Boston, Massachusetts, 02115
Regeneron Study Site
Boston, Massachusetts, 02118
Regeneron Study Site
Boston, Massachusetts, 02215
Regeneron Study Site
Buffalo, New York, 14203
Regeneron Study Site
Chapel Hill, North Carolina, 27599
Regeneron Study Site
Charleston, South Carolina, 29406
Regeneron Study Site
Charleston, South Carolina, 29425
Regeneron Study Site
Charlotte, North Carolina, 28209
Regeneron Study Site
Charlottesville, Virginia, 22903
Regeneron Study Site
Chattanooga, Tennessee, 37421
Regeneron Study Site
Chicago, Illinois, 60607
Regeneron Study Site 2
Chicago, Illinois, 60612
Regeneron Study Site 3
Chicago, Illinois, 60612
Regeneron Study Site
Chicago, Illinois, 60612
Regeneron Study Site
Cincinnati, Ohio, 45267-0405
Regeneron Study Site
Clearwater, Florida, 33756
Regeneron Study Site
Clinton, South Carolina, 29325
Regeneron Study Site
Colorado Springs, Colorado, 80907
Regeneron Study Site
Columbus, Georgia, 31904
Regeneron Study Site
Columbus, Ohio, 43210
Regeneron Study Site
Columbus, Ohio, 43215
Regeneron Study Site
Corpus Christi, Texas, 78413
Regeneron Study Site
Dallas, Texas, 75224
Regeneron Study Site
Danville, Pennsylvania, 17822
Regeneron Study Site
Dayton, Ohio, 45432
Regeneron Study Site
Decatur, Georgia, 30030
Regeneron Study Site
DeLand, Florida, 32720
Regeneron Study Site
Detroit, Michigan, 48202
Regeneron Study Site 1
Downers Grove, Illinois, 60515
Regeneron Study Site 2
Downers Grove, Illinois, 60515
Regeneron Study Site
Eatonton, Georgia, 31024
Regeneron Study Site
Everett, Washington, 98201
Regeneron Study Site
Fayetteville, North Carolina, 28304
Regeneron Study Site
Ft. Pierce, Florida, 34982
Regeneron Study Site
Gaffney, South Carolina, 29340
Regeneron Study Site
Gulfport, Mississippi, 39503
Regeneron Study Site
Hazelwood, Missouri, 63042
Regeneron Study Site
Hialeah, Florida, 33010
Regeneron Study Site
Houston, Texas, 77008
Regeneron Study Site
Houston, Texas, 77024
Regeneron Study Site
Houston, Texas, 77026
Regeneron Study Site
Houston, Texas, 77057
Regeneron Study Site
Houston, Texas, 77093
Regeneron Study Site
Jackson, Mississippi, 39216
Regeneron Study Site
Jacksonville, Florida, 32216
Regeneron Study Site
Knoxville, Tennessee, 37920
Regeneron Study Site
La Mesa, California, 91942
Regeneron Study Site
La Palma, California, 90623
Regeneron Study Site
Lake Charles, Louisiana, 70601
Regeneron Study Site
Lakeland, Florida, 33810
Regeneron Study Site
Las Vegas, Nevada, 89104
Regeneron Study Site
Las Vegas, Nevada, 89109
Regeneron Study Site
Long Beach, California, 90806
Regeneron Study Site
Los Angeles, California, 90035
Regeneron Study Site
Los Angeles, California, 90036
Regeneron Study Site
Los Angeles, California, 90095
Regeneron Study Site
Loxahatchee Groves, Florida, 33470
Regeneron Study Site
Madison, Wisconsin, 53792
Regeneron Study Site
Maitland, Florida, 32751
Regeneron Study Site
Marietta, Georgia, 30060
Regeneron Study Site
Marrero, Louisiana, 70072
Regeneron Study Site
Memphis, Tennessee, 38103
Regeneron Study Site
Mesa, Arizona, 85210
Regeneron Study Site
Metairie, Louisiana, 70006
Regeneron Study Site
Miami, Florida, 33012
Regeneron Study Site
Miami, Florida, 33125
Regeneron Study Site
Miami, Florida, 33126
Regeneron Study Site
Miami, Florida, 33136
Regeneron Study Site
Miami, Florida, 33144
Regeneron Study Site
Miami, Florida, 33184
Regeneron Study Site
Miami, Florida, 33186
Regeneron Study Site
Minneapolis, Minnesota, 55455
Regeneron Study Site
Montclair, California, 91763
Regeneron Study Site
Morristown, New Jersey, 07960
Regeneron Study Site
Nashville, Tennessee, 37232
Regeneron Study Site
New Orleans, Louisiana, 70112
Regeneron Study Site
New York, New York, 10016
Regeneron Study Site
New York, New York, 10027
Regeneron Study Site
New York, New York, 10029
Regeneron Study Site
New York, New York, 10032
Regeneron Study Site
New York, New York, 10037
Regeneron Study Site
New York, New York, 10065
Regeneron Study Site
Newark, New Jersey, 07103
Regeneron Study Site
Northridge, California, 91324
Regeneron Study Site
Orlando, Florida, 32803
Regeneron Study Site
Oxnard, California, 93030
Regeneron Study Site
Pearland, Texas, 77584
Regeneron Study Site
Philadelphia, Pennsylvania, 19104
Regeneron Study Site
Philadelphia, Pennsylvania, 19140
Regeneron Study Site
Providence, Rhode Island, 02906
Regeneron Study Site
Raleigh, North Carolina, 27612
Regeneron Study Site
Red Oak, Texas, 75154
Regeneron Study Site
Richmond, Virginia, 23298
Regeneron Study Site
Royal Oak, Michigan, 48073
Regeneron Study Site
Sacramento, California, 95817
Regeneron Study Site
Sacramento, California, 95821
Regeneron Study Site
San Antonio, Texas, 78249
Regeneron Study Site
San Diego, California, 92108
Regeneron Study Site
San Francisco, California, 94127
Regeneron Study Site
Sandy Springs, Georgia, 30328
Regeneron Study Site
Sarasota, Florida, 34239
Regeneron Study Site
Seattle, Washington, 98104
Regeneron Study Site
Sioux Falls, South Dakota, 57105
Regeneron Study Site
St Louis, Missouri, 63110
Regeneron Study Site
Stanford, California, 94305
Regeneron Study Site
Summit, New Jersey, 07901
Regeneron Study Site
Tampa, Florida, 33612
Regeneron Study Site
Teaneck, New Jersey, 07666-4245
Regeneron Study Site 1
The Bronx, New York, 10451
Regeneron Study Site 2
The Bronx, New York, 10451
Regeneron Study Site
The Bronx, New York, 10461
Regeneron Study Site
Torrance, California, 90502
Regeneron Study Site
Torrance, California, 90505
Regeneron Study Site
Tucson, Arizona, 85712
Regeneron Study Site
Tucson, Arizona, 85724
Regeneron Study Site
Tyler, Texas, 75701
Regeneron Study Site
Washington D.C., District of Columbia, 20005
Regeneron Study Site
West Palm Beach, Florida, 33407
Regeneron Study Site
Wilkes-Barre, Pennsylvania, 18711
Regeneron Study Site
Wilmington, North Carolina, 28401
Regeneron Study Site
Winston-Salem, North Carolina, 27103
Regeneron Study Site
Winter Park, Florida, 32789
Regeneron Study Site
Yakima, Washington, 98902
About this study
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
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
Read the 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
- Conditions
- Healthy Participants
- Being tested
- REGN10933 + REGN10987, Placebo
- Keywords
- Asymptomatic, Individuals at risk of exposure to SARS-CoV-2, Household Contacts of a Person Infected with SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN10933 + REGN10987Drug
Also called REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™
Subcutaneous (SC) or Intramuscular (IM) injections
PlaceboDrug
SC or IM injections
| Study group | Role | What they receive |
|---|---|---|
| REGN10933 + REGN10987 | Experimental | Not described Receives: Drug: REGN10933 + REGN10987 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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
High viral load (> 4 log 10 copies/ml)
Measured: Up to 1 month
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP
Measured: Up to 1 month
Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP
High viral load (> 4 log 10 copies/ml)
Measured: Up to 1 month
Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
Measured: 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
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)
Measured: 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)
Measured: Up to 1 month
Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
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.
Measured: Up to 1 month
Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
Measured: 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
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)
Measured: Up to 1 month
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
Measured: 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
Measured: 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
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.
Measured: 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
Measured: 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
Measured: 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
The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP
Measured: 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
Measured: 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
Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)
Measured: Up to 1 month
Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
Measured: Up to 8 months
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Measured: Up to Day 29
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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)
Measured: 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
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)
Measured: 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
Measured: 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
Measured: Up to 14 Days
Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples
Measured: Up to day 8 visit
Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 1 month
Concentrations of REGN10987 in Serum Over Time (Cohort A)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Up to 8 months
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
Measured: Up to 8 months
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
(TE\&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Measured: Up to 8 months
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
(TE\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Measured: Up to 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start13 Jul 2020
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452318
- Sponsor's protocol ID
- R10933-10987-COV-2069
- Other IDs
- 2020-003654-71
- Status last verified
- Apr 2023
- First submitted
- 26 Jun 2020
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Publications
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.
PubMed 37330602Herman 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.
PubMed 35803290Hirsch 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.
PubMed 35713300O'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.
PubMed 35029629Kreuzberger 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.
PubMed 34473343O'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.
PubMed 34347950O'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.
PubMed 34159344O'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.
PubMed 34159343
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04452318
- Acronym / sponsor ID
- R10933-10987-COV-2069
- Conditions
- Healthy Participants
- Keywords
- Asymptomatic, Individuals at risk of exposure to SARS-CoV-2, Household Contacts of a Person Infected with SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,303 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Posted 15 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGN10933 + REGN10987 | Experimental | Drug: REGN10933 + REGN10987 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN10933 + REGN10987Also: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™Subcutaneous (SC) or Intramuscular (IM) injections | Drug | REGN10933 + REGN10987 |
| PlaceboSC or IM injections | Drug | Placebo |
Primary outcome
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.
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).
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
53 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
Time frame: 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
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)
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
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)
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
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)
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
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
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
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
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
Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples
Time frame: 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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37330602Follmann 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.
- Derived from this study: PubMed 35803290Herman 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.
- Derived from this study: PubMed 35713300Hirsch 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.
- Derived from this study: PubMed 35029629O'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.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Derived from this study: PubMed 34347950O'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.
- Derived from this study: PubMed 34159344O'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.
- Derived from this study: PubMed 34159343O'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.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
134 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REGN10933 + REGN10987 in people with Healthy Participants, run by Regeneron Pharmaceuticals at 134 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 134 sites in United States, Moldova, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452318, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.