Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

January 25, 2023 updated by: Regeneron Pharmaceuticals

A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19

The primary objectives are:

Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)

To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation

Phase 1/2 (Cohort 1)

To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

Study Overview

Status

Completed

Conditions

COVID-19

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2252

Phase

Phase 2
Phase 1

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

Brazil
- - São Paulo, Brazil, 02401- 400
    - Regeneron Study Site
  - São Paulo, Brazil, 04012-909
    - Regeneron Study Site
  - São Paulo, Brazil, 05403-010
    - Regeneron Study Site
- Bahia
  - Salvador, Bahia, Brazil, 40170-130
    - Regeneron Study Site
- Ceara
  - Fortaleza, Ceara, Brazil, 60160-230
    - Regeneron Study Site
- Paraná
  - Curitiba, Paraná, Brazil, 80810-040
    - Regeneron Study Site
- RS
  - Passo Fundo, RS, Brazil, 99010-170
    - Regeneron Study Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Regeneron Study Site
- Santa Catarina
  - Chapeco, Santa Catarina, Brazil, 89801-355
    - Regeneron Study Site
  - Criciuma, Santa Catarina, Brazil, 88811-508
    - Regeneron Study Site
- Sao Paolo
  - Botucatu, Sao Paolo, Brazil, 18618-686
    - Regeneron Study Site
  - Campinas, Sao Paolo, Brazil, 13060-080
    - Regeneron Study Site
Chile
- - Santiago de Chile, Chile, 7500691
    - Regeneron Study Site
- Santiago De Chile
  - Las Condes, Santiago De Chile, Chile, 7591047
    - Regeneron Study Site 1
  - Las Condes, Santiago De Chile, Chile, 7591047
    - Regeneron Study Site 2
  - Vitacura, Santiago De Chile, Chile, 7650568
    - Regeneron Study Site
Mexico
- - Culiacan, Mexico, 80230
    - Regeneron Study Site
  - Monterrey, Mexico, 64060
    - Regeneron Study Site
  - Mérida, Mexico, 97000
    - Regeneron Study Site 1
  - Mérida, Mexico, 97000
    - Regeneron Study Site 2
  - Veracruz, Mexico, 91700
    - Regeneron Study Site
  - Zapopan, Mexico, 45170
    - Regeneron Study Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44340
    - Regeneron Study Site
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64718
    - Regeneron Study Site
- Sinaloa
  - Culiacán, Sinaloa, Mexico, 80020
    - Regeneron Study Site
Moldova, Republic of
- - Chisinau, Moldova, Republic of, MD-2025
    - Regeneron Study Site
Romania
- - Bucuresti, Romania, 021105
    - Regeneron Study Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35249
    - Regeneron Study Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - Regeneron Study Site
  - Phoenix, Arizona, United States, 85006
    - Regeneron Study Site
  - Tucson, Arizona, United States, 85724
    - Regeneron Study Site 1
- California
  - Long Beach, California, United States, 90806
    - Regeneron Study Site
  - Mission Hills, California, United States, 91345
    - Regeneron Study Site
  - Sacramento, California, United States, 95817
    - Regeneron Study Site
  - Santa Monica, California, United States, 90404
    - Regeneron Study Site
  - Stanford, California, United States, 94305
    - Regeneron Study Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Regeneron Study Site
- Florida
  - Boca Raton, Florida, United States, 33486
    - Regeneron Study Site
  - Fort Pierce, Florida, United States, 34982
    - Regeneron Study Site
  - Gainesville, Florida, United States, 32610
    - Regeneron Study Site
  - Orlando, Florida, United States, 32803
    - Regeneron Study Site
  - Pensacola, Florida, United States, 32504
    - Regeneron Study Site
  - Sarasota, Florida, United States, 34239
    - Regeneron Study Site
  - Tampa, Florida, United States, 33612
    - Regeneron Study Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Regeneron Study Site
  - Atlanta, Georgia, United States, 30309
    - Regeneron Study Site
  - Augusta, Georgia, United States, 30912
    - Regeneron Study Site
  - Marietta, Georgia, United States, 30060
    - Regeneron Study Site
- Illinois
  - Chicago, Illinois, United States, 60612
    - Regeneron Study Site
  - Chicago, Illinois, United States, 60611
    - Regeneron Study Site
  - Glenview, Illinois, United States, 60026
    - Regeneron Study Site
  - Urbana, Illinois, United States, 61801
    - Regeneron Study Site
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - Regeneron Study Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Regeneron Study Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Regeneron Study Site
  - Louisville, Kentucky, United States, 40217
    - Regeneron Study Site
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Regeneron Study Site
  - New Orleans, Louisiana, United States, 70122
    - Regeneron Study Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Regeneron Study Site
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Regeneron Study Site
  - Boston, Massachusetts, United States, 02115
    - Regeneron Study Site
  - Boston, Massachusetts, United States, 02118
    - Regeneron Study Site
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Regeneron Study Site
  - Royal Oak, Michigan, United States, 48073
    - Regeneron Study Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Regeneron Study Site
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Regeneron Study Site
  - Saint Louis, Missouri, United States, 63104
    - Regeneron Study Site
  - Saint Louis, Missouri, United States, 63110
    - Regeneron Study Site
- Nebraska
  - Omaha, Nebraska, United States, 68198-5400
    - Regeneron Study Site
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Regeneron Study Site
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Regeneron Study Site
  - Hackensack, New Jersey, United States, 07601
    - Regeneron Study Site
  - Morristown, New Jersey, United States, 07960
    - Regeneron Study Site
  - Neptune, New Jersey, United States, 07753
    - Regeneron Study Site
  - Pennington, New Jersey, United States, 08534
    - Regeneron Study Site
  - Summit, New Jersey, United States, 07901
    - Regeneron Study Site
  - Teaneck, New Jersey, United States, 07666
    - Regeneron Study Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Regeneron Study Site
- New York
  - Bronx, New York, United States, 10461
    - Regeneron Study Site
  - Bronx, New York, United States, 10451
    - Regeneron Study Site
  - Brooklyn, New York, United States, 11219
    - Regeneron Study Site
  - Buffalo, New York, United States, 14203
    - Regeneron Study Site
  - Buffalo, New York, United States, 14215
    - Regeneron Study Site 1
  - Buffalo, New York, United States, 14215
    - Regeneron Study Site 2
  - Jamaica, New York, United States, 11432
    - 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, 10003
    - Regeneron Study Site
  - New York, New York, United States, 10019
    - Regeneron Study Site
  - New York, New York, United States, 10025
    - Regeneron Study Site
  - New York, New York, United States, 10037
    - Regeneron Study Site
  - Rochester, New York, United States, 14642
    - Regeneron Study Site
  - Syracuse, New York, United States, 13210
    - Regeneron Study Site
  - West Islip, New York, United States, 11795
    - Regeneron Study Site
  - White Plains, New York, United States, 10601
    - Regeneron Study Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - Regeneron Study Site
  - Greensboro, North Carolina, United States, 27408
    - Regeneron Study Site
- Ohio
  - Columbus, Ohio, United States, 43215
    - Regeneron Study Site
  - Columbus, Ohio, United States, 43210
    - Regeneron Study Site
  - Dayton, Ohio, United States, 45409
    - Regeneron Study Site
- Oregon
  - Portland, Oregon, United States, 97239
    - Regeneron Study Site
  - Portland, Oregon, United States, 97213
    - Regeneron Study Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Regeneron Study Site
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Regeneron Study Site
  - Providence, Rhode Island, United States, 02906
    - Regeneron Study Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57108
    - Regeneron Study Site
- Texas
  - Amarillo, Texas, United States, 79106
    - Regeneron Study Site 1
  - Amarillo, Texas, United States, 79106
    - Regeneron Study Site 2
  - Dallas, Texas, United States, 75246
    - Regeneron Study Site
  - Dallas, Texas, United States, 75390
    - Regeneron Study Site
  - Dallas, Texas, United States, 75235
    - Regeneron Study Site
  - Houston, Texas, United States, 77030
    - Regeneron Study Site
  - Houston, Texas, United States, 77004
    - Regeneron Study Site
  - Houston, Texas, United States, 77024
    - Regeneron Study Site
  - Lubbock, Texas, United States, 79410
    - Regeneron Study Site
  - Sugar Land, Texas, United States, 77479
    - Regeneron Study Site
  - Tyler, Texas, United States, 75701
    - Regeneron Study Site
- Utah
  - Murray, Utah, United States, 84107
    - Regeneron Study Site
  - Salt Lake City, Utah, United States, 84143
    - Regeneron Study Site
- Virginia
  - Richmond, Virginia, United States, 23298
    - Regeneron Study Site
- Washington
  - Everett, Washington, United States, 98201
    - Regeneron Study Site
  - Seattle, Washington, United States, 98122
    - Regeneron Study Site 1
- 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization
Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:
1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
2. Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol
3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
4. Cohort 3: On mechanical ventilation

Key Exclusion Criteria:

Phase 1 Only: Patients maintaining O2 saturation >94% on room air
In the opinion of the investigator, unlikely to survive for >48 hours from screening
Receiving extracorporeal membrane oxygenation (ECMO)
Has new-onset stroke or seizure disorder during hospitalization
Initiated on renal replacement therapy due to COVID-19

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: On Low-Flow Oxygen Cohort 1 (C1): O2 saturation >93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device	Drug: REGN10933+REGN10987 combination therapy Administered intravenously (IV) single dose Other Names: REGN-COV2 REGEN-COV™ Ronapreve™ casirivimab imdevimab Drug: Placebo Placebo IV Single Dose
Experimental: With COVID-19 symptoms but not requiring supplemental O2 Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen	Drug: REGN10933+REGN10987 combination therapy Administered intravenously (IV) single dose Other Names: REGN-COV2 REGEN-COV™ Ronapreve™ casirivimab imdevimab Drug: Placebo Placebo IV Single Dose
Experimental: High O2 No Mechanical Ventilation Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation	Drug: REGN10933+REGN10987 combination therapy Administered intravenously (IV) single dose Other Names: REGN-COV2 REGEN-COV™ Ronapreve™ casirivimab imdevimab Drug: Placebo Placebo IV Single Dose
Experimental: On Mechanical Ventilation Cohort 3 (C3): On mechanical ventilation	Drug: REGN10933+REGN10987 combination therapy Administered intravenously (IV) single dose Other Names: REGN-COV2 REGEN-COV™ Ronapreve™ casirivimab imdevimab Drug: Placebo Placebo IV Single Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS Time Frame: Day 1 to Day 7	Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.	Day 1 to Day 7
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS Time Frame: Day 6 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.	Day 6 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS Time Frame: Day 6 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.	Day 6 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS Time Frame: Day 6 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.	Day 6 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS Time Frame: Day 1 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.	Day 1 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS Time Frame: Day 1 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.	Day 1 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS Time Frame: Day 1 to Day 29	Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.	Day 1 to Day 29
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events Time Frame: Up to Day 169	Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.	Up to Day 169
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4 Time Frame: Up to Day 4	Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).	Up to Day 4
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29 Time Frame: Up to Day 29	Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.	Up to Day 29
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS Time Frame: Up to Day 29	Cumulative incidence percentage was estimated using Kaplan-Meier method.	Up to Day 29
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS Time Frame: Up to Day 29	Cumulative incidence percentage was estimated using Kaplan-Meier method.	Up to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS Time Frame: by Day 29	Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS Time Frame: Day 6 to Day 29	Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.	Day 6 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS Time Frame: Day 6 to Day 29	Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.	Day 6 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS Time Frame: Day 1 to Day 29	Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.	Day 1 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS Time Frame: Day 1 to Day 29	Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.	Day 1 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS Time Frame: by Day 29	Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS Time Frame: Up to Day 29	Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.	Up to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS Time Frame: by Day 29	Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS Time Frame: by Day 29	Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS Time Frame: by Day 29	Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS Time Frame: Up to Day 56	Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.	Up to Day 56
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS Time Frame: Up to Day 56	Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.	Up to Day 56
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events Time Frame: Up to Day 169		Up to Day 169
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4 Time Frame: Up to Day 4		Up to Day 4
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29 Time Frame: Up to Day 29		Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.	by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS Time Frame: Day 6 to Day 29	Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.	Day 6 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS Time Frame: Day 1 to Day 29	Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.	Day 1 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.	by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS Time Frame: Up to Day 29	Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.	Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS Time Frame: Up to Day 29	Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS Time Frame: by Day 29	Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS Time Frame: Up to Day 56	Time to discharge from hospital up to Day 56 was reported.	Up to Day 56
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS Time Frame: Day 1 to Day 11	TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.	Day 1 to Day 11
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29 Time Frame: Day 1 to Day 29	TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.	Day 1 to Day 29
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time Time Frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29	Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.	Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time Time Frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29	Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.	Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS Time Frame: by Day 29	Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.	by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS Time Frame: Day 6 to Day 29	Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.	Day 6 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS Time Frame: Day 1 to Day 29	Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.	Day 1 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS Time Frame: by Day 29	Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.	by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS Time Frame: Up to Day 29	Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.	Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS Time Frame: Up to Day 29	Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS Time Frame: Up to Day 29	Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS Time Frame: Up to Day 29	Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.	Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS Time Frame: Up to Day 56	Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.	Up to Day 56
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS Time Frame: Up to Day 29	Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.	Up to Day 29
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS Time Frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29	Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.	Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS Time Frame: Through Day 29		Through Day 29
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS Time Frame: Through Day 29		Through Day 29
Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28) Time Frame: Up to Day 28		Up to Day 28
Concentration at the End of Infusion (Ceoi) Time Frame: Day 1		Day 1
Concentration at Day 28 (C28) Time Frame: Day 28		Day 28
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 Time Frame: Through Day 169		Through Day 169
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 Time Frame: Through Day 169		Through Day 169
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933 Time Frame: Through Day 57		Through Day 57
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987 Time Frame: Through Day 57		Through Day 57

Collaborators and Investigators

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

Sponsor

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)

June 10, 2020

Primary Completion (Actual)

May 7, 2021

Study Completion (Actual)

October 22, 2021

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

R10933-10987-COV-2066
2020-002537-15 (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., Food and Drug Administration (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on COVID-19

Clinical Trials on REGN10933+REGN10987 combination therapy

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