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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 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 3,303 participants.

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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

Interventions

  • DRUG Placebo
  • DRUG REGN10933 + REGN10987

Trial Details

FieldValue
Enrollment Target 3,303 participants
Start Date 2020-07-13
Est. Completion 2021-10-04
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

280 total trials

What the Registry Record Tells You About NCT04452318

The ClinicalTrials.gov registry entry for NCT04452318 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,303 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04452318 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.