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NCT04426695 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
A Phase 1 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 2,252
- Enrollment target
NCT04426695: Completed Phase 1 study, sponsored by Regeneron Pharmaceuticals.
NCT04426695 is a Phase 1 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 2,252 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (3653% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04426695, a Phase 1 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2,252 participants
- Enrollment target
Study Summary
The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 * To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) * To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
Primary Outcome
Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Interventions
- DRUG Placebo
- DRUG REGN10933+REGN10987 combination therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,252 participants |
| Start Date | 2020-06-10 |
| Est. Completion | 2021-10-22 |
| Phase | Phase 1 |
What the finished NCT04426695 record still lists
NCT04426695 is an interventional study that assigns participants to a tested intervention. Its 2,252 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (3653% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04426695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04426695 about?
NCT04426695 is a clinical study titled "Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19". The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 * To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or...
What is the current status of trial NCT04426695?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2,252 participants. The study started on 2020-06-10. Estimated completion is 2021-10-22.
What interventions are being tested in trial NCT04426695?
The interventions under investigation include: Placebo (DRUG), REGN10933+REGN10987 combination therapy (DRUG).
Who is sponsoring clinical trial NCT04426695?
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 NCT04426695's enrollment target sits among peer trials
2,252 3rd of 2000 higher than 1,998 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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