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
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: SARS-CoV-2
In brief
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
Key facts
- Study ID
- NCT05081388
- Run by
- Regeneron Pharmaceuticals
- People needed
- 25
- Starts
- 2021-11-08
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2025-10-28
Who can join
Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Regeneron Research Site — La Mesa, California, United States
- Ark Clinical Research — Long Beach, California, United States
- PNS Clinical Research, LLC — Mission Viejo, California, United States
- Regeneron Research Site — Ft. Pierce, Florida, United States
- AGA Clinical Trials — Hialeah, Florida, United States
- Regeneron Research Site — Loxahatchee Groves, Florida, United States
- Project 4 Research, Inc. — Miami, Florida, United States
- Universal Medical and Research Center, LLC — Miami, Florida, United States
- Global Medical Trials — Miami, Florida, United States
- Bio-Medical Research LLC — Miami, Florida, United States
- Charisma Research and Medical Center — Miami Lakes, Florida, United States
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Regeneron Research Site — Winter Park, Florida, United States
- IACT Health — Columbus, Georgia, United States
- Chicago Clinical Research Institute — Chicago, Illinois, United States
- Regeneron Research Site — Ames, Iowa, United States
- Regeneron Research Site — Marrero, Louisiana, United States
- Olive Branch Family Medical Center — Olive Branch, Mississippi, United States
- Forte Family Practice — Las Vegas, Nevada, United States
- New York Health and Hospitals / Lincoln — The Bronx, New York, United States
- NYC H+H / Jacobi Medical Center — The Bronx, New York, United States
- Regeneron Research Site — Wilmington, North Carolina, United States
- Regeneron Research Site — Dayton, Ohio, United States
- Carolina Medical Research — Clinton, South Carolina, United States
- PharmaTex Research, LLC — Amarillo, Texas, United States
Full record on ClinicalTrials.gov
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