Clinical trial NCT04432298: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: Severe Acute Respiratory Syndrome coronavirus
SARS-COV-2 infection
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Proof-of-concept
Primary purpose: TREATMENT

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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate \[DNR/DNI\] order or a resource limitation).

Eligibility 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

Primary outcomes:
measure: Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28
timeFrame: Day 28
measure: Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14
timeFrame: Day 14
measure: Time to Recovery as Based on a Modified 8-Point Ordinal Scale
timeFrame: Day 28
measure: Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)
timeFrame: up to Day 28
measure: Days on Mechanical Ventilation and/or ECMO
timeFrame: up to Day 28
measure: Time to Mechanical Ventilation/ECMO or All-cause Mortality
timeFrame: up to Day 28
measure: Number of Participants With All-cause Mortality
timeFrame: up to Day 28
measure: Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables
timeFrame: up to Day 28
measure: Time to Death From Any Cause
timeFrame: up to Day 28
measure: Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2
timeFrame: up to Day 28
measure: Change in (Non-invasive) Oxygen Supplementation Requirements
timeFrame: up to Day 28
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Research Center
state: Michigan
city: Greensboro
country: United States
facility: Research Center
state: North Carolina
city: Philadelphia
country: United States
facility: Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Center
state: Pennsylvania
Study officials:
References: