Back to resultsStudy of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pamrevlumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Severe Acute Respiratory Syndrome coronavirus, SARS-COV-2 infection
Eligibility Criteria
Inclusion Criteria:
- Confirmed SARS-CoV-2 infection
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
- Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
- Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28
Exclusion Criteria:
- Female participants who are pregnant or nursing
- Participation in a clinical trial with another investigational drug for COVID-19 disease
- 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
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
Sites / Locations
- Research Center
- Research Center
- Research Center
- Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pamrevlumab
Placebo
Arm Description
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
Outcomes
Primary Outcome Measures
Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
Secondary Outcome Measures
Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28
Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14
Time to Recovery as Based on a Modified 8-Point Ordinal Scale
Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).
Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)
Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.
Days on Mechanical Ventilation and/or ECMO
Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.
Time to Mechanical Ventilation/ECMO or All-cause Mortality
Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.
Number of Participants With All-cause Mortality
Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables
Time to Death From Any Cause
Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.
Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2
Change in (Non-invasive) Oxygen Supplementation Requirements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04432298
Brief Title
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated by Sponsor due to low enrollment.
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
March 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Severe Acute Respiratory Syndrome coronavirus, SARS-COV-2 infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Proof-of-concept
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pamrevlumab
Arm Type
Experimental
Arm Description
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
Intervention Type
Drug
Intervention Name(s)
Pamrevlumab
Other Intervention Name(s)
FG-3019
Intervention Description
Sterile liquid for injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile liquid for injection
Primary Outcome Measure Information:
Title
Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28
Time Frame
Day 28
Title
Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14
Time Frame
Day 14
Title
Time to Recovery as Based on a Modified 8-Point Ordinal Scale
Description
Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).
Time Frame
Day 28
Title
Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)
Description
Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.
Time Frame
up to Day 28
Title
Days on Mechanical Ventilation and/or ECMO
Description
Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.
Time Frame
up to Day 28
Title
Time to Mechanical Ventilation/ECMO or All-cause Mortality
Description
Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.
Time Frame
up to Day 28
Title
Number of Participants With All-cause Mortality
Time Frame
up to Day 28
Title
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
Title
Time to Death From Any Cause
Description
Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.
Time Frame
up to Day 28
Title
Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2
Time Frame
up to Day 28
Title
Change in (Non-invasive) Oxygen Supplementation Requirements
Time Frame
up to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Confirmed SARS-CoV-2 infection
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
Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28
Exclusion Criteria:
Female participants who are pregnant or nursing
Participation in a clinical trial with another investigational drug for COVID-19 disease
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
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
Facility Information:
Facility Name
Research Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
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