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NCT04452318 · ClinicalTrials.gov registry record · Phase 3
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,303
- Enrollment target
NCT04452318: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT04452318 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 3,303 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (328% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04452318, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,303 participants
- Enrollment target
Study Summary
Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term) Cohort B and Cohort B1 • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo
Primary Outcome
Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.
Interventions
- DRUG Placebo
- DRUG REGN10933 + REGN10987
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,303 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2021-10-04 |
| Phase | Phase 3 |
What the finished NCT04452318 record still lists
NCT04452318 is an interventional study that assigns participants to a tested intervention. Its 3,303 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (328% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04452318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04452318 about?
NCT04452318 is a clinical study titled "COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay". Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC...
What is the current status of trial NCT04452318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,303 participants. The study started on 2020-07-13. Estimated completion is 2021-10-04.
What interventions are being tested in trial NCT04452318?
The interventions under investigation include: Placebo (DRUG), REGN10933 + REGN10987 (DRUG).
Who is sponsoring clinical trial NCT04452318?
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 NCT04452318's enrollment target sits among peer trials
3,303 72nd of 2000 higher than 1,929 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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