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NCT04425629 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 10,078
- Enrollment target
NCT04425629: Clinical Trial Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT04425629 is a Phase 3 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 10,078 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1207% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04425629, a Phase 3 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 10,078 participants
- Enrollment target
Study 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
Primary Outcome
Primary: Phase 1, Phase 3 (Cohort 2 and Cohort 3) Secondary: Phase 2, Phase 3 (Cohort 1)
Interventions
- DRUG casirivimab+imdevimab combination therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,078 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2022-06-09 |
| Phase | Phase 3 |
Why NCT04425629 stopped before completion
NCT04425629 is an interventional study that assigns participants to a tested intervention. Its 10,078 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1207% higher).
The record links to 0 conditions, and to 1 intervention - of which casirivimab+imdevimab combination therapy is the first listed.
NCT04425629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04425629 about?
NCT04425629 is a clinical study titled "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". 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...
What is the current status of trial NCT04425629?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 10,078 participants. The study started on 2020-06-16. Estimated completion is 2022-06-09.
What interventions are being tested in trial NCT04425629?
The interventions under investigation include: casirivimab+imdevimab combination therapy (DRUG).
Who is sponsoring clinical trial NCT04425629?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04425629's enrollment target sits among peer trials
10,078 27th of 2000 higher than 1,974 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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