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

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

Recruiting
40-85 years
All
Phase 2

This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy and safety of intravenous pamrevlumab, a monoclonal antibody against connective-tissue growth factor (CTGF), in hospitalized subjects with acute COVID-19 disease.

Eligible subjects are those with documented SARS-CoV-2 infection, age 40 to 85 years, with evidence of respiratory compromise requiring hospital admission.

Approximately 130 subjects will be randomized in a 1:1 ratio to either pamrevlumab or placebo, in addition to standard-of-care.

Study drug (35 mg/kg) administration is via IV infusion on Days 1, 7, 14 and 28. A follow-up by visit will be performed 4 weeks after the last dose.

All concomitant medications, including approved and non-approved treatments for COVID-19 (e.g., hydroxychloroquine, IL-6 inhibitors, etc.), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of 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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (e.g., DNR/DNI order, resource limitation).

Study details
    Covid 19

NCT04432298

FibroGen

19 February 2024

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