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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

NCT04425629 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10078

Last updated 2023-12-21

Study results available
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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

Conditions

Interventions

DRUG

casirivimab+imdevimab combination therapy

Administered intravenously (IV) single dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2022-01-21
Completion
2022-06-09
FDA Drug
Yes

Countries

  • United States
  • Mexico
  • Romania

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04425629 on ClinicalTrials.gov