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Monoclonal Antibodies

casirivimab+imdevimab for COVID-19

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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 169
Awards & highlights

Study Summary

The primary objectives of the study are: To characterize the concentrations of casirivimab+imdevimab in serum over time To evaluate the safety and tolerability of casirivimab+imdevimab The secondary objective of the study is: • To assess the immunogenicity of casirivimab+imdevimab

Eligible Conditions
  • COVID-19
  • Coronavirus

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentrations of casirivimab+imdevimab in serum over time
Proportion of patients with hypersensitivity reactions
Proportion of patients with infusion-related reactions
+1 more
Secondary outcome measures
Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time
Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time

Trial Design

1Treatment groups
Experimental Treatment
Group I: casirivimab+imdevimabExperimental Treatment1 Intervention
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
621 Previous Clinical Trials
380,603 Total Patients Enrolled
13 Trials studying COVID-19
19,128 Patients Enrolled for COVID-19
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
251,412 Total Patients Enrolled
10 Trials studying COVID-19
18,868 Patients Enrolled for COVID-19

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
COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
2021. "COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05092581.
~1 spots leftby Apr 2025
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