Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Patients With Acute COVID-19 Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04432298|
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Pamrevlumab Drug: Placebo||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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (e.g., DNR/DNI order, resource limitation).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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, a Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF), in Hospitalized Patients With Acute COVID-19 Disease|
|Actual Study Start Date :||June 20, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Pamrevlumab: 35 mg/kg on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
Other Name: FG-3019
Placebo: 35 mg/kg on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
- Proportion of subjects who never received mechanical ventilation and/or ECMO and alive [ Time Frame: Baseline to Day 28 ]
- Proportion of subjects alive, discharged home, and not on supplemental oxygen [ Time Frame: Baseline to Day 28 ]
- Time to recovery based on a Modified 8-Point Ordinal Scale [ Time Frame: Baseline to Day 28 ]
- Days in ICU/CCU (either on or off mechanical ventilation and/or ECMO) [ Time Frame: Baseline to Day 28 ]
- Days on mechanical ventilation and/or ECMO [ Time Frame: Baseline to Day 28 ]
- Time to death from any cause [ Time Frame: Baseline to Day 28 ]
- Changes in PaO2/FiO2 ratio, both as categorical and continuous variable [ Time Frame: Baseline to Day 28 ]
- Change in (non-invasive) oxygen supplementation requirements [ Time Frame: Baseline to Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432298
|Contact: Gustavo Lorente||650-273-2264||glorente@Fibrogen.com|
|United States, North Carolina|
|Greensboro, North Carolina, United States, 27403|