Study of the Efficacy and Safety of Intravenous Pamrevlumab in Hospitalized Patients With Acute COVID-19 Disease
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- STATUS
- Recruiting
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- participants needed
- 130
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- sponsor
- FibroGen
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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (e.g., DNR/DNI order, resource limitation).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 | 40-85 years |
| Treatment | Placebo, Pamrevlumab |
| Clinical Study Identifier | NCT04432298 |
| Sponsor | FibroGen |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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