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Monoclonal Antibodies

casirivimab+imdevimab for Immunocompromised

Phase 3
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days postdose for the q4w groups and 84 days postdose for the q12 group
Awards & highlights

Study Summary

This study is evaluating whether a drug called casirivimab+imdevimab can prevent people with cancer from getting sick from the new coronavirus.

Eligible Conditions
  • Immunocompromised

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days postdose for the q4w groups and 84 days postdose for the q12 group
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days postdose for the q4w groups and 84 days postdose for the q12 group for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
Secondary outcome measures
Concentration of Casirivimab Over Time
Concentration of Imdevimab Over Time
Incidence of Adverse Events of Special Interest (AESIs) During the EAP
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: casirivimab+imdevimab Q4WExperimental Treatment1 Intervention
SC dose Q4W
Group II: casirivimab+imdevimab Q12WExperimental Treatment1 Intervention
SC dose every 12 weeks (Q12W)
Group III: casirivimab+imdevimab Initial + Q4WExperimental Treatment1 Intervention
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
Group IV: PlaceboPlacebo Group1 Intervention
SC dose Q4W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
casirivimab+imdevimab
2021
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
617 Previous Clinical Trials
380,139 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
260 Previous Clinical Trials
250,976 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
2021. "A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05074433.
~19 spots leftby Apr 2025
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