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Monoclonal Antibodies

casirivimab+imdevimab combination therapy for COVID-19

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
Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva)
Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by day 29, day 120, and day 169
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective at reducing viral load for people with SARS-CoV-2. The trial is divided into three phases, with the first phase testing for safety and tolerability, the second for virologic efficacy, and the third for clinical efficacy.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by day 29, day 120, and day 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and by day 29, day 120, and 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
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
+4 more
Secondary outcome measures
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
+80 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: casirivimab+imdevimab low doseExperimental Treatment1 Intervention
Low dose or body-weight equivalent for those under 18 years of age.

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
369,667 Total Patients Enrolled
13 Trials studying COVID-19
9,052 Patients Enrolled for COVID-19
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
258 Previous Clinical Trials
240,907 Total Patients Enrolled
10 Trials studying COVID-19
8,792 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.
~2122 spots leftby Mar 2025