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Trial record 1 of 1 for:    pamrevlumab | covid
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Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Patients With Acute COVID-19 Disease

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ClinicalTrials.gov Identifier: NCT04432298
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
FibroGen

Brief 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.

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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (e.g., DNR/DNI order, resource limitation).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

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

Experimental: Placebo Drug: Placebo
Placebo: 35 mg/kg on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks




Primary Outcome Measures :
  1. Proportion of subjects who never received mechanical ventilation and/or ECMO and alive [ Time Frame: Baseline to Day 28 ]

Secondary Outcome Measures :
  1. Proportion of subjects alive, discharged home, and not on supplemental oxygen [ Time Frame: Baseline to Day 28 ]
  2. Time to recovery based on a Modified 8-Point Ordinal Scale [ Time Frame: Baseline to Day 28 ]
  3. Days in ICU/CCU (either on or off mechanical ventilation and/or ECMO) [ Time Frame: Baseline to Day 28 ]
  4. Days on mechanical ventilation and/or ECMO [ Time Frame: Baseline to Day 28 ]
  5. Time to death from any cause [ Time Frame: Baseline to Day 28 ]
  6. Changes in PaO2/FiO2 ratio, both as categorical and continuous variable [ Time Frame: Baseline to Day 28 ]
  7. Change in (non-invasive) oxygen supplementation requirements [ Time Frame: Baseline 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. Age 40-85 years
  2. Confirmed SARS-CoV-2 infection
  3. 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
  4. Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
  5. Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28

Exclusion Criteria:

  1. Female subjects 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


Contacts
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Contact: Gustavo Lorente 650-273-2264 glorente@Fibrogen.com

Locations
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United States, North Carolina
Research Center Recruiting
Greensboro, North Carolina, United States, 27403
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: June 24, 2020
Last Verified: June 2020
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:
SARS-COV-2 infection