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
Public ClinicalTrials.gov record NCT05081388. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2/3 Adaptive Study to Evaluate the Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Patients Without Risk Factors for Progression to Severe Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05081388
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 8, 2021 (Actual)
- Primary completion
- Jun 30, 2022 (Actual)
- Completion
- Jun 30, 2022 (Actual)
- Last update posted
- Oct 28, 2025
2021 – 2022
United States locations
- U.S. sites
- 28
- U.S. states
- 13
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Research Site | La Mesa | California | 91941 | — |
| Ark Clinical Research | Long Beach | California | 90806 | — |
| PNS Clinical Research, LLC | Mission Viejo | California | 92691 | — |
| Regeneron Research Site | Ft. Pierce | Florida | 34982 | — |
| AGA Clinical Trials | Hialeah | Florida | 33012 | — |
| Regeneron Research Site | Loxahatchee Groves | Florida | 33470 | — |
| Project 4 Research, Inc. | Miami | Florida | 33125 | — |
| Universal Medical and Research Center, LLC | Miami | Florida | 33126 | — |
| Global Medical Trials | Miami | Florida | 33174 | — |
| Bio-Medical Research LLC | Miami | Florida | 33184 | — |
| Charisma Research and Medical Center | Miami Lakes | Florida | 33014 | — |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | — |
| Regeneron Research Site | Winter Park | Florida | 32789 | — |
| IACT Health | Columbus | Georgia | 31904 | — |
| Chicago Clinical Research Institute | Chicago | Illinois | 60607 | — |
| Regeneron Research Site | Ames | Iowa | 50010 | — |
| Regeneron Research Site | Marrero | Louisiana | 70072 | — |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | — |
| Forte Family Practice | Las Vegas | Nevada | 89103 | — |
| New York Health and Hospitals / Lincoln | The Bronx | New York | 10451 | — |
| NYC H+H / Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Regeneron Research Site | Wilmington | North Carolina | 28401 | — |
| Regeneron Research Site | Dayton | Ohio | 45409 | — |
| Carolina Medical Research | Clinton | South Carolina | 29325 | — |
| PharmaTex Research, LLC | Amarillo | Texas | 79109 | — |
| Advanced Diagnostics Clinic, River Oaks Hospital and Clinics | Houston | Texas | 77027 | — |
| Regeneron Research Site | Houston | Texas | 77030 | — |
| Regeneron Research Site | Houston | Texas | 77093 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05081388, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05081388 live on ClinicalTrials.gov.