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

  • STATUS
    Recruiting
  • participants needed
    130
  • sponsor
    FibroGen
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Updated on 19 February 2024
See if I qualify
mechanical ventilation
pneumonia
oximetry
covid-19
SARS
extracorporeal membrane oxygenation
capillary oxygen saturation
acute respiratory syndrome (sars)

Summary

This is a Phase 2 trial to evaluate the efficacy and safety of intravenous (IV) infusions of pamrevlumab as compared to placebo in hospitalized subjects with acute COVID-19 disease.

Description

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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (e.g., DNR/DNI order, resource limitation).

Details
Condition Covid 19
Age 40years - 85years
Treatment Placebo, Pamrevlumab
Clinical Study IdentifierNCT04432298
SponsorFibroGen
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 40-85 years
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 CXR or HRCT (findings of consolidation or ground glass opacities), OR
Peripheral capillary oxygen saturation (SpO2) < 94% on room air, OR
Requiring non-invasive supplemental oxygen (e.g., 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 Criteria

Female subjects 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 -
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    Research Center

    Greensboro NC United States

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Investigator Avatar
Gustavo Lorente

Primary Contact

Research Center

Greensboro NC United States

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acute respiratory syndrome (sars)

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