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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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