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UPMC OPTIMISE-C19 Trial, a COVID-19 Study

NCT04790786 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4571

Last updated 2023-06-15

Study results available
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Summary

Multiple monoclonal antibodies (mABs) have been shown to reduce viral burden and improve clinical outcomes, have been granted FDA Emergency Use Authorization (EUA) for use in select populations, and are routinely used in the UPMC Health System, which has made expanded access a priority. However, the comparative effectiveness of these mABS is unknown. The National Academies of Sciences, Engineering, and Medicine has called for expanded access and clinical use of mABs, noting it is "critical to collect data and evaluate whether they are working as predicted". This pragmatic evaluation will determine the relative effects of the EUA-governed mABs versus each other. When U.S. government mAB policies change (e.g., FDA grants or revokes EUAs), UPMC Health System policies and the evaluated mABs will accordingly change.

Conditions

  • Covid19

Interventions

BIOLOGICAL

Lilly Bamlanivimab

Administration of Lilly Bamlanivimab to COVID positive patients

BIOLOGICAL

Regeneron Casirivimab + Imdevimab

Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients

BIOLOGICAL

Lilly Bamlanivimab + Etesevimab

Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients

BIOLOGICAL

Sotrovimab

Administration of Sotrovimab to COVID positive patients

BIOLOGICAL

Bebtelovimab

Administration of Bebtelovimab to COVID positive patients

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Erin McCreary

    lead OTHER

Principal Investigators

  • Erin McCreary, PharmD · University of Pittsburgh

  • David T Huang, MD, MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2022-06-16
Completion
2022-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04790786 on ClinicalTrials.gov