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.
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 factor (CTGF), in participants hospitalized with acute COVID-19
disease.
All concomitant medications, including approved and non-approved treatments for COVID-19
(such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental
oxygenation needs, will be collected and recorded. In addition, the following will be
collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus
(SARS-Cov-2) infection, documentation of any other infection(s) prior to or during
hospitalization, and whether or not aggressive care is withheld or withdrawn, including the
reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate
[DNR/DNI] order or a resource limitation).
Drug: Pamrevlumab
Sterile liquid for injection
Other Name: FG-3019
Drug: Placebo
Sterile liquid for injection
Inclusion Criteria:
1. Confirmed SARS-CoV-2 infection
2. 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
3. Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO)
use at time of randomization
4. Not participating in another clinical trial for the treatment of COVID-19 disease
through Day 28
Exclusion Criteria:
1. Female participants who are pregnant or nursing
2. Participation in a clinical trial with another investigational drug for COVID-19
disease
3. 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
4. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies
Research Center
Detroit, Michigan, United States
Research Center
Greensboro, North Carolina, United States
Research Center
Philadelphia, Pennsylvania, United States
Research Center
Philadelphia, Pennsylvania, United States