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

FibroGen

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Drug: Pamrevlumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04432298

FGCL-3019-098

Details and patient eligibility

About

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.

Full description

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

All concomitant medications, including approved and non-approved treatments for COVID-19 (such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus (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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate [DNR/DNI] order or a resource limitation).

Enrollment: 22 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Pamrevlumab

Experimental group

Description:

Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks

Treatment:

Drug: Pamrevlumab

Placebo

Experimental group

Description:

Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks

Treatment:

Drug: Placebo