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Monoclonal Antibodies

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

Phase 1
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 through day 169

Summary

This trial is testing a new drug called REGN14256, both alone and with another drug called imdevimab, in COVID-19 patients. The goal is to see if these drugs can help reduce the amount of virus in the body and improve symptoms. The drugs work by using special proteins that help the immune system fight off the virus.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 169 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Injection-site Reactions (ISRs)
Severity of ISRs (Injection Site Reactions)
Severity of TEAEs
+2 more
Secondary study objectives
Change From Baseline in Viral Load
Change From Baseline in Viral Load (Phase 1)
Concentrations of Imdevimab in Serum Over Time
+15 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: casirivimab + imdevimabExperimental Treatment2 Interventions
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
Group II: REGN14256 + imdevimabExperimental Treatment2 Interventions
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1 Phase 3: (Open label) (≥12 and \<18 Years)
Group III: REGN14256Experimental Treatment1 Intervention
Phase 1, Phase 2: Randomized 1:1:1:1:1
Group IV: PlaceboExperimental Treatment1 Intervention
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
Group V: ImdevimabExperimental Treatment1 Intervention
Phase 1, Phase 2: Randomized 1:1:1:1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
385,799 Total Patients Enrolled
13 Trials studying COVID-19
19,105 Patients Enrolled for COVID-19
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,892 Total Patients Enrolled
10 Trials studying COVID-19
18,845 Patients Enrolled for COVID-19
~6 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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