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

December 20, 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 Ambulatory Patients With COVID-19

Phase 1

To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 2

• To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 3

Cohort 1 (≥18 Years Old, Not Pregnant at Randomization)
• To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death
Cohort 2 (<18 Years Old, Not Pregnant at Randomization)
- To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
- To further characterize the concentrations of REGN10933 and REGN10987 in serum over time
Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987

Study Overview

Status

Terminated

Conditions

COVID-19

Intervention / Treatment

Drug: casirivimab+imdevimab combination therapy

Study Type

Interventional

Enrollment (Actual)

10078

Phase

Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

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

Mexico
- - Chihuahua, Mexico, 31238
    - Regeneron Study Site
  - Ciudad de Mexico, Mexico, 3100
    - Regeneron Study Site
  - Durango, Mexico, 34000
    - Regeneron Study Site
  - Mérida, Mexico, 97000
    - Regeneron Study Site
  - Veracruz, Mexico, 91900
    - Regeneron Study Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Regeneron Study Site
  - Guadalajara, Jalisco, Mexico, 44340
    - Regeneron Study Site
  - Zapopan, Jalisco, Mexico, 45070
    - Regeneron Study Site
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64718
    - Regeneron Study Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - Regeneron Study Site
- Yucatan
  - Merida, Yucatan, Mexico, 97070
    - Regeneron Study Site
Romania
- - Bucuresti, Romania, 021105
    - Regeneron Study Site
United States
- Arizona
  - Mesa, Arizona, United States, 85210
    - Regeneron Study Site
  - Tucson, Arizona, United States, 85712
    - Regeneron Study Site
  - Tucson, Arizona, United States, 85724
    - Regeneron Study Site
- California
  - Canoga Park, California, United States, 91303
    - Regeneron Study Site
  - La Mesa, California, United States, 91942
    - Regeneron Study Site
  - La Palma, California, United States, 90623
    - Regeneron Study Site
  - Long Beach, California, United States, 90806
    - Regeneron Study Site 1
  - Long Beach, California, United States, 90806
    - Regeneron Study Site 2
  - Long Beach, California, United States, 90806
    - Regeneron Study Site 3
  - Los Angeles, California, United States, 90036
    - Regeneron Study Site
  - Montclair, California, United States, 91763
    - Regeneron Study Site
  - Rolling Hills Estates, California, United States, 90274
    - Regeneron Study Site
  - Sacramento, California, United States, 95817
    - Regeneron Study Site
  - San Francisco, California, United States, 94127
    - 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
  - Colorado Springs, Colorado, United States, 80907
    - Regeneron Study Site
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - Regeneron Study Site
- Florida
  - Boca Raton, Florida, United States, 33487
    - Regeneron Study Site
  - DeLand, Florida, United States, 32720
    - Regeneron Study Site
  - Fort Pierce, Florida, United States, 34982
    - Regeneron Study Site
  - Hialeah, Florida, United States, 33010
    - Regeneron Study Site
  - Loxahatchee Groves, Florida, United States, 33470
    - Regeneron Study Site
  - Maitland, Florida, United States, 32751
    - Regeneron Study Site
  - Miami, Florida, United States, 33012
    - Regeneron Study Site
  - Miami, Florida, United States, 33126
    - Regeneron Study Site 1
  - Miami, Florida, United States, 33126
    - Regeneron Study Site 2
  - Miami, Florida, United States, 33130
    - Regeneron Study Site
  - Miami, Florida, United States, 33144
    - Regeneron Study Site
  - Miami, Florida, United States, 33184
    - Regeneron Study Site
  - Saint Petersburg, Florida, United States, 33705
    - Regeneron Study Site
  - Sarasota, Florida, United States, 34239
    - Regeneron Study Site
  - Tampa, Florida, United States, 33606
    - Regeneron Study Site
  - West Palm Beach, Florida, United States, 33407
    - Regeneron Study Site
  - Winter Haven, Florida, United States, 33880
    - Regeneron Study Site
  - Winter Park, Florida, United States, 32789
    - Regeneron Study Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Regeneron Study Site
  - Atlanta, Georgia, United States, 30309
    - Regeneron Study Site
  - Augusta, Georgia, United States, 30912
    - Regeneron Study Site
  - Columbus, Georgia, United States, 31904
    - Regeneron Study Site
  - Marietta, Georgia, United States, 30060
    - Regeneron Study Site
- Illinois
  - Chicago, Illinois, United States, 60607
    - Regeneron Study Site
  - Downers Grove, Illinois, United States, 60515
    - Regeneron Study Site 1
  - Downers Grove, Illinois, United States, 60515
    - Regeneron Study Site 2
  - Downers Grove, Illinois, United States, 60515
    - Regeneron Study Site
- Iowa
  - Ames, Iowa, United States, 50010-3014
    - Regeneron Study Site
  - Iowa City, Iowa, United States, 52242
    - Regeneron Study Site
- Louisiana
  - Lake Charles, Louisiana, United States, 70601
    - Regeneron Study Site
  - Marrero, Louisiana, United States, 70072
    - Regeneron Study Site
  - New Orleans, Louisiana, United States, 70114
    - Regeneron Study Site
  - Shreveport, Louisiana, United States, 71118
    - Regeneron Study Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Regeneron Study Site
- Michigan
  - Royal Oak, Michigan, United States, 48073
    - Regeneron Study Site
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Regeneron Study Site
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Regeneron Study Site
- New Jersey
  - Ridgewood, New Jersey, United States, 07450
    - Regeneron Study Site
  - Teaneck, New Jersey, United States, 07666
    - Regeneron Study Site
- New Mexico
  - Santa Fe, New Mexico, United States, 87505
    - Regeneron Study Site
- New York
  - Bronx, New York, United States, 10461
    - Regeneron Study Site
  - Bronx, New York, United States, 10451
    - Regeneron Study Site
  - 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
- North Carolina
  - Charlotte, North Carolina, United States, 28209
    - Regeneron Study Site
  - Durham, North Carolina, United States, 27710
    - Regeneron Study Site
  - Wilmington, North Carolina, United States, 28401
    - Regeneron Study Site
- Ohio
  - Columbus, Ohio, United States, 43215
    - Regeneron Study Site
  - Dayton, Ohio, United States, 45409
    - Regeneron Study Site
  - Dayton, Ohio, United States, 45432
    - Regeneron Study Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Regeneron Study Site
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Regeneron Study Site
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Regeneron Study Site
  - Clinton, South Carolina, United States, 29325
    - Regeneron Study Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57108
    - Regeneron Study Site
- Tennessee
  - Memphis, Tennessee, United States, 38103
    - Regeneron Study Site
  - Memphis, Tennessee, United States, 38103
    - Regeneron Study Site 2
- Texas
  - Amarillo, Texas, United States, 79109
    - Regeneron Study Site
  - Corpus Christi, Texas, United States, 78413
    - Regeneron Study Site
  - Dallas, Texas, United States, 75246
    - Regeneron Study Site
  - Dallas, Texas, United States, 75390
    - Regeneron Study Site
  - Houston, Texas, United States, 77030
    - Regeneron Study Site
  - Houston, Texas, United States, 77004
    - Regeneron Study Site
  - Houston, Texas, United States, 77008
    - Regeneron Study Site
  - Houston, Texas, United States, 77055
    - Regeneron Study Site
  - Houston, Texas, United States, 77057
    - Regeneron Study Site
  - Houston, Texas, United States, 77093
    - Regeneron Study Site
  - Pearland, Texas, United States, 77584
    - Regeneron Study Site
  - Red Oak, Texas, United States, 75154
    - Regeneron Study Site
  - San Antonio, Texas, United States, 78215
    - Regeneron Study Site
  - San Antonio, Texas, United States, 78217
    - Regeneron Study Site
  - San Antonio, Texas, United States, 78249
    - Regeneron Study Site
  - Tyler, Texas, United States, 75708
    - Regeneron Study Site
- Virginia
  - Falls Church, Virginia, United States, 22042
    - Regeneron Study Site
- Washington
  - Everett, Washington, United States, 98201
    - Regeneron Study Site
  - Seattle, Washington, United States, 98109
    - Regeneron Study Site
  - Seattle, Washington, United States, 98122
    - Regeneron Study Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - Regeneron Study Site

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva)
Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization
Maintains O2 saturation ≥93% on room air
Is able to understand and complete study-related questionnaires (patients aged ≥12 years only)

Key Exclusion Criteria:

Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
Prior use (prior to randomization), current use (at randomization) or planned use (within 90 days of study drug administration or per current CDC recommendations, as applicable) of any authorized or approved vaccine for COVID-19
Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for 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: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: casirivimab+imdevimab low dose Low dose or body-weight equivalent for those under 18 years of age.	Drug: casirivimab+imdevimab combination therapy Administered intravenously (IV) single dose Other Names: REGN-COV2 REGEN-COV™ Ronapreve™ REGN10933 REGN10987

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3] Time Frame: Through Day 29	Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)	Through Day 29
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) Time Frame: Through Day 4	Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)	Through Day 4
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3) Time Frame: Through Day 29	Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)	Through Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2) Time Frame: Baseline up to Day 7	Primary: Phase 1, Phase 2	Baseline up to Day 7
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo) Time Frame: Through Day 29	Primary: Phase 3 (Cohort 1)	Through Day 29
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2) Time Frame: Up to Nominal Sampling Day 28	Phase 3 Cohort 2 [Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]	Up to Nominal Sampling Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo) Time Frame: Up to Day 29	Phase 3 Cohort 1	Up to Day 29
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo) Time Frame: Through Day 29	Phase 3 (Cohort 1)	Through Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo) Time Frame: Day 4 thru Day 29	Phase 3 (Cohort 1)	Day 4 thru Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo) Time Frame: From Day 4 Through Day 29	Phase 3 (Cohort 1)	From Day 4 Through Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort) Time Frame: Day 5, Day 7, Day 15, Day 29	Next Phase 2 Symptomatic	Day 5, Day 7, Day 15, Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2) Time Frame: Day 1 to Day 29	Phase 1, Phase 2	Day 1 to Day 29
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2) Time Frame: Through Day 29	Phase 1, Phase 2	Through Day 29
Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2) Time Frame: Through Day 29	Phase 1, Phase 2	Through Day 29
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only) Time Frame: Up to Day 29	Phase 2 Only	Up to Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV Time Frame: Through Day 29	Phase 3 Cohort 1 - Placebo vs. 1.2 g IV	Through Day 29
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV Time Frame: Through day 29	Phase 3 (Cohort 1)	Through day 29
Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3) Time Frame: Up to Nominal Sampling Day 28	Secondary: Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 3) - Symptomatic Participants [Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]	Up to Nominal Sampling Day 28
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1) Time Frame: Through Day 29	Phase 1 Only	Through Day 29
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1) Time Frame: Through Day 29	Phase 1 Only	Through Day 29
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1) Time Frame: Through Day 29	Phase 1 Only	Through Day 29
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1) Time Frame: Through Day 29	Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants	Through Day 29
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3) Time Frame: Through Day 29	Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants	Through Day 29
Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1) Time Frame: Through Day 29	Phase 1, Phase 2, Phase 3 (Cohort 1) - Pooled Symptomatic Participants	Through Day 29
Immunogenicity as Measured by ADA to REGN10987 (Ph3 Cohort 2 and Cohort 3) Time Frame: Through Day 29	Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants	Through Day 29
Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3) Time Frame: Through Day 29	Symptomatic Participants Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants (TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay	Through Day 29
Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3) Time Frame: Through Day 29	Phase 3 Cohort 2 Participants Phase 3 Cohort 3 Participants (TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay	Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2) Time Frame: Through Day 29	Phase 3 (Cohort 2)	Through Day 29
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2) Time Frame: Through Day 29	Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits	Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV Time Frame: Through Day 29	Phase 3 (Cohort 1)	Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2) Time Frame: Through Day 29	Phase 1 and Phase 2	Through Day 29
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only) Time Frame: Through Day 29	Phase 1 Only	Through Day 29
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only) Time Frame: Though Day 29	Phase 1 Only	Though Day 29
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only) Time Frame: Through Day 29	Phase 1 Only	Through Day 29
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only) Time Frame: Through Day 29	Phase 1 Only - Tlast (Time of last quantifiable concentration)	Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Day 4 Through Day 29	Phase 3 Cohort 1	Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Day 4 Through Day 29	Phase 3 Cohort 1	Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2) Time Frame: Through Day 29	Phase 3 (Cohort 2)	Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2) Time Frame: Through Day 29	Phase 3 (Cohort 2)	Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g Time Frame: by Day 29, Day 120, and Day 169	Phase 3 Cohort 1	by Day 29, Day 120, and Day 169
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g Time Frame: by Day 29, Day 120, and Day 169	Phase 3 Cohort 1 Placebo vs. 2.4g IV	by Day 29, Day 120, and Day 169
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only) Time Frame: Through Day 29	Next Phase 2 Only	Through Day 29
Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only) Time Frame: Up to Day 29	Phase 1 Only	Up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only) Time Frame: Baseline Up To Day 29	Phase 1 Only	Baseline Up To Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only) Time Frame: Baseline Up to Day 29	Phase 1 Only	Baseline Up to Day 29
Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only) Time Frame: Up To Day 29	Phase 1 Only	Up To Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1) Time Frame: Baseline up to Day 22	Phase 1 Only	Baseline up to Day 22
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only) Time Frame: Through Day 29	Phase 2 Only	Through Day 29
Duration of Symptoms Consistent With COVID-19 (Phase 2 Only) Time Frame: Through Day 29	Phase 2 Only	Through Day 29
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only) Time Frame: Through Day 29	Phase 2 Only	Through Day 29
Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2) Time Frame: Through Day 29	Phase 1, Phase 2	Through Day 29
Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only) Time Frame: Through Day 29	Phase 1 Only	Through Day 29
Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic) Time Frame: Through Day 29	Phase 2 Asymptomatic	Through Day 29
Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 169	Phase 3 Cohort 1 (1.2g IV)	Through Day 169
Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 169	Phase 3 Cohort 1 (2.4g IV)	Through Day 169
Time to All-cause Death (Phase 3 Cohort 2) Time Frame: Through Day 29	Phase 3 (Cohort 2)	Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo) Time Frame: Through Day 29		Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo) Time Frame: Through Day 29		Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2) Time Frame: Through Day 29	Phase 3 (Cohort 2)	Through Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo) Time Frame: Baseline up to Day 29	Phase 3 Cohort 1	Baseline up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo) Time Frame: Baseline up to Day 29	Phase 3 Cohort 1	Baseline up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2) Time Frame: Baseline up to Day 29	Phase 3 Cohort 2	Baseline up to Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1) Time Frame: Baseline to Day 7	Phase 3 (Cohort 1)	Baseline to Day 7
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2) Time Frame: Baseline to Day 7	Phase 3 (Cohort 2)	Baseline to Day 7
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only) Time Frame: Day 0, Day 5, Day 7, Day 15, Day 29	Next Phase 2 Symptomatic	Day 0, Day 5, Day 7, Day 15, Day 29
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only) Time Frame: Day 0, Day 5, Day 7, Day 15, Day 29	Next Phase 2 Symptomatic	Day 0, Day 5, Day 7, Day 15, Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV Time Frame: Through Day 29	Phase 3 (Cohort 1)	Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV Time Frame: Through Day 29	Phase 3 (Cohort 1)	Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2) Time Frame: Through Day 29	Phase 3 (Cohort 2)	Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic) Time Frame: Up to Day 29	Phase 2 Only	Up to Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV Time Frame: Through Day 29	Phase 3 (Cohort 1)	Through Day 29
Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV Time Frame: Through Day 29	Phase 3 (Cohort 1)	Through Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2) Time Frame: Through Day 29	Phase 3 (Cohort 2)	Through Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87 Time Frame: Through Day 29	Next Phase 2	Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g Time Frame: Through Day 29	Phase 3 Cohort 1	Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2) Time Frame: Through Day 29	Phase 3 Cohort 2	Through Day 29

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

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

General Publications

Study record dates

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

Study Major Dates

Study Start (Actual)

June 16, 2020

Primary Completion (Actual)

January 21, 2022

Study Completion (Actual)

June 9, 2022

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

R10933-10987-COV-2067
2020-003690-21 (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
SAP
ICF
ANALYTIC_CODE
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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

Expanded Access

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

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

Investigators

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 (Estimated)

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 casirivimab+imdevimab combination therapy

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