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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04432298
• Other study ID #: FGCL-3019-098
• Status: Terminated
• Phase: Phase 2
• Start date: June 20, 2020
• Est. completion date: March 22, 2021

Study information

• Verified date: June 2022
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate [DNR/DNI] order or a resource limitation).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Pamrevlumab
Sterile liquid for injection
• Placebo
Sterile liquid for injection

Locations

Country	Name	City	State
United States	Research Center	Detroit	Michigan
United States	Research Center	Greensboro	North Carolina
United States	Research Center	Philadelphia	Pennsylvania
United States	Research Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28		Day 28
Secondary	Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28		Day 28
Secondary	Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14		Day 14
Secondary	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).	Day 28
Secondary	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.	up to Day 28
Secondary	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.	up to Day 28
Secondary	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.	up to Day 28
Secondary	Number of Participants With All-cause Mortality		up to Day 28
Secondary	Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables		up to Day 28
Secondary	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.	up to Day 28
Secondary	Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2		up to Day 28
Secondary	Change in (Non-invasive) Oxygen Supplementation Requirements		up to Day 28