A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Immunocompromised
In brief
The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants. The secondary objectives of the study are: * To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population * To characterize concentrations of casirivimab and imdevimab in serum over time * To assess the immunogenicity of casirivimab and imdevimab
Key facts
- Study ID
- NCT05074433
- Run by
- Regeneron Pharmaceuticals
- People needed
- 66
- Starts
- 2021-10-25
- Expected to finish
- 2022-05-18
- Last updated by the study team
- 2025-10-20
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
- Regeneron Study Site — Long Beach, California, United States
- Regeneron Study Site — Los Angeles, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Stanford University — Palo Alto, California, United States
- University of California — Sacramento, California, United States
- Regeneron Study Site — Stanford, California, United States
- James R Berenson MD Inc. — West Hollywood, California, United States
- University Of Colorado — Aurora, Colorado, United States
- Regeneron Study Site — North Haven, Connecticut, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
- Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- Elixia COVID-19 — Hollywood, Florida, United States
- AppleMed Research Group, LLC — Miami, Florida, United States
- De La Cruz Research Center, LLC — Miami, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Florida Medical Clinic, LLC — Zephyrhills, Florida, United States
- Regeneron Study Site — Atlanta, Georgia, United States
- Regeneron Study Site — Marietta, Georgia, United States
- Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States
- University of Iowa — Iowa City, Iowa, United States
- Tulane University — New Orleans, Louisiana, United States
- Central Alabama Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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