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

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ClinicalTrials.gov Identifier: NCT04432298
Recruitment Status : Terminated (The study was terminated by Sponsor due to low enrollment.)
First Posted : June 16, 2020
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
FibroGen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Pamrevlumab Drug: Placebo Phase 2

Detailed 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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate [DNR/DNI] order or a resource limitation).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Proof-of-concept
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : March 22, 2021
Actual Study Completion Date : March 22, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pamrevlumab
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
Drug: Pamrevlumab
Sterile liquid for injection
Other Name: FG-3019

Experimental: Placebo
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
Drug: Placebo
Sterile liquid for injection




Primary Outcome Measures :
  1. Proportion of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: up to Day 28 ]

Secondary Outcome Measures :
  1. Proportion of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: up to Day 14 ]
  2. Proportion of Participants Alive, Discharged Home, and Not on Supplemental Oxygen [ Time Frame: up to Day 28 ]
  3. Time to Recovery as Based on a Modified 8-Point Ordinal Scale [ Time Frame: up to Day 28 ]
  4. Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or off Mechanical Ventilation and/or ECMO) [ Time Frame: up to Day 28 ]
  5. Days on Mechanical Ventilation and/or ECMO [ Time Frame: up to Day 28 ]
  6. Time to Death from Any Cause [ Time Frame: up to Day 28 ]
  7. Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables [ Time Frame: up to Day 28 ]
  8. Change in Resting Peripheral oxygen saturation (SpO2) Adjusted by FiO2 [ Time Frame: up to Day 28 ]
  9. Change in (Non-invasive) Oxygen Supplementation Requirements [ Time Frame: up to Day 28 ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Michigan
Research Center
Detroit, Michigan, United States, 48202
United States, North Carolina
Research Center
Greensboro, North Carolina, United States, 27403
United States, Pennsylvania
Research Center
Philadelphia, Pennsylvania, United States, 19107
Research Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
FibroGen
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT04432298    
Other Study ID Numbers: FGCL-3019-098
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FibroGen:
Severe Acute Respiratory Syndrome coronavirus
SARS-COV-2 infection