Status:
TERMINATED
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
Lead Sponsor:
FibroGen
Conditions:
COVID-19
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
Detailed Description
This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against connective-tissue growth f...
Eligibility Criteria
Inclusion
- Confirmed SARS-CoV-2 infection
- Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by at least one (or more) of the following criteria:
- Interstitial pneumonia on chest x-ray or high-resolution computed tomography (findings of consolidation or ground glass opacities), OR
- Peripheral capillary oxygen saturation \< 94% on room air, OR
- Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to maintain SpO2
- Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
- Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28
Exclusion
- Female participants who are pregnant or nursing
- Participation in a clinical trial with another investigational drug for COVID-19 disease
- Anticipated discharge from the hospital or transfer to another hospital or long-term care facility which is not a study site within 72 hours of randomization
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04432298
Start Date
June 20 2020
End Date
March 22 2021
Last Update
July 18 2022
Active Locations (4)
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1
Research Center
Detroit, Michigan, United States, 48202
2
Research Center
Greensboro, North Carolina, United States, 27403
3
Research Center
Philadelphia, Pennsylvania, United States, 19107
4
Research Center
Philadelphia, Pennsylvania, United States, 19140