Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease

• Status: Terminated
• Trial end date: 2021-03-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FibroGen

Criteria

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