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A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults

NCT05074433 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-10-17

Study results available
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Summary

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

Conditions

  • Immunocompromised

Interventions

DRUG

casirivimab+imdevimab

Co-administered sequentially subcutaneous (SC)

DRUG

Placebo

Administered SC

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2022-05-18
Completion
2022-05-18
FDA Drug
Yes

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074433 on ClinicalTrials.gov