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NCT04425629

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

Last Updated: 2023-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

10078 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2022-06-09

Brief Summary

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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

Detailed Description

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Conditions

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COVID-19

Keywords

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Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Phase 1/Phase 2/Phase 3

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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casirivimab+imdevimab low dose

Low dose or body-weight equivalent for those under 18 years of age.

Group Type EXPERIMENTAL

casirivimab+imdevimab combination therapy

Intervention Type DRUG

Administered intravenously (IV) single dose

Interventions

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casirivimab+imdevimab combination therapy

Administered intravenously (IV) single dose

Intervention Type DRUG

Other Intervention Names

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REGN-COV2 REGN10933 REGN10987 REGEN-COV™ Ronapreve™

Eligibility Criteria

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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)

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Mesa, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Canoga Park, California, United States

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La Mesa, California, United States

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La Palma, California, United States

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Long Beach, California, United States

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Regeneron Study Site 2

Long Beach, California, United States

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Regeneron Study Site 3

Long Beach, California, United States

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Los Angeles, California, United States

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Montclair, California, United States

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Rolling Hills Estates, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Stanford, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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DeLand, Florida, United States

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Ft. Pierce, Florida, United States

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Hialeah, Florida, United States

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Loxahatchee Groves, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Regeneron Study Site 2

Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Winter Haven, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Downers Grove, Illinois, United States

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Downers Grove, Illinois, United States

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Downers Grove, Illinois, United States

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Ames, Iowa, United States

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Iowa City, Iowa, United States

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Lake Charles, Louisiana, United States

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Marrero, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Royal Oak, Michigan, United States

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Jackson, Mississippi, United States

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Las Vegas, Nevada, United States

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Ridgewood, New Jersey, United States

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Teaneck, New Jersey, United States

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Santa Fe, New Mexico, United States

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