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NCT05081388 · ClinicalTrials.gov registry record · Phase 1
COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease
A Phase 1 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT05081388 is a Phase 1 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 25 participants.
The verdict
NCT05081388, a Phase 1 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7 Phase 1/2/3 (Clinical Efficacy) • Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs) Phase 2 and Phase 3 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity) * Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy * Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy * Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy
Interventions
- DRUG Placebo
- DRUG REGN14256
- DRUG imdevimab
- DRUG casirivimab + imdevimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-11-08 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05081388
The ClinicalTrials.gov registry entry for NCT05081388 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 25 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 4 interventions - of which Placebo is the first listed.
NCT05081388 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05081388 about?
NCT05081388 is a clinical study titled "COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease". Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • E...
What is the current status of trial NCT05081388?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-11-08. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT05081388?
The interventions under investigation include: Placebo (DRUG), REGN14256 (DRUG), imdevimab (DRUG), casirivimab + imdevimab (DRUG).
Who is sponsoring clinical trial NCT05081388?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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