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Monoclonal Antibodies
Regeneron Casirivimab + Imdevimab for Coronavirus (OPTIMISE-C19 Trial)
Phase 4
Waitlist Available
Led By David Huang, MD
Research Sponsored by University of Pittsburgh Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
COVID-19 positive patients
Eligible for mAB under FDA EUA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study
Awards & highlights
OPTIMISE-C19 Trial Summary
This study is evaluating whether multiple monoclonal antibodies may be effective in treating Ebola.
Eligible Conditions
- Coronavirus
OPTIMISE-C19 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOPTIMISE-C19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days after initial participation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after initial participation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital-free Days
Secondary outcome measures
All-cause Mortality at 28 Days
Detection of SARS-CoV-2 Variants Through Next-generation Sequencing
Duration of SAR-CoV-2 Infectivity
+7 moreOPTIMISE-C19 Trial Design
5Treatment groups
Experimental Treatment
Group I: SotrovimabExperimental Treatment1 Intervention
The monoclonal antibody of sotrovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset.
Group II: Regeneron Casirivimab + ImdevimabExperimental Treatment1 Intervention
The Regeneron monoclonal antibody cocktail Casirivimab + Imdevimab will be administered according to FDA EUA guidelines. Dosing is 1200 mg of each drug (2400 mg total) administered intravenously times one within 10 days of COVID-19 symptom onset.
Group III: Lilly Bamlanivimab + EtesevimabExperimental Treatment1 Intervention
The Lilly monoclonal antibody cocktail of bamlanivimab + etesevimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 10 days of COVID-19 symptom onset.
Group IV: Lilly BamlanivimabExperimental Treatment1 Intervention
The Lilly monoclonal antibody bamlanivimab will be administered according to FDA EUA guidelines. Dosing is 700 mg intravenously times one within 10 days of COVID-19 symptom onset.
Group V: BebtelovimabExperimental Treatment1 Intervention
The monoclonal antibody of bebtelovimab will be administered according to FDA EUA guidelines. Dosing is given intravenously times one within 7 days of COVID-19 symptom onset.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotrovimab
2022
Completed Phase 3
~540
Bebtelovimab
2020
Completed Phase 2
~1760
Find a Location
Who is running the clinical trial?
University of Pittsburgh Medical CenterLead Sponsor
70 Previous Clinical Trials
71,679 Total Patients Enrolled
David T HuangLead Sponsor
Erin McCrearyLead Sponsor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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