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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT04425629•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (114)

Regeneron Study Site

Mesa, Arizona, United States

Regeneron Study Site

Tucson, Arizona, United States

Regeneron Study Site

Tucson, Arizona, United States

Regeneron Study Site

Canoga Park, California, United States

Regeneron Study Site

La Mesa, California, United States

Regeneron Study Site

La Palma, California, United States

Regeneron Study Site 1

Long Beach, California, United States

Regeneron Study Site 2

Long Beach, California, United States

Regeneron Study Site 3

Long Beach, California, United States

Regeneron Study Site

Los Angeles, California, United States

Key Dates

Start Date

June 16, 2020

Primary Completion Date

January 21, 2022

Completion Date

June 9, 2022

Last Updated

December 21, 2023

Enrollment

10,078

ACTUAL participants

Conditions

COVID-19

Interventions

casirivimab+imdevimab combination therapy

DRUG

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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RECRUITINGPHASE1

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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