NCT04432298

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 20, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 18, 2022

Completed
Last Updated

July 18, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 12, 2020

Results QC Date

April 27, 2022

Last Update Submit

July 14, 2022

Conditions

COVID-19

Keywords

Severe Acute Respiratory Syndrome coronavirusSARS-COV-2 infection

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28

    Day 28

Secondary Outcomes (11)

  • Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28

    Day 28

  • Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14

    Day 14

  • Time to Recovery as Based on a Modified 8-Point Ordinal Scale

    Day 28

  • Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)

    up to Day 28

  • Days on Mechanical Ventilation and/or ECMO

    up to Day 28

  • +6 more secondary outcomes

Study Arms (2)

Pamrevlumab

EXPERIMENTAL

Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks

Drug: Pamrevlumab

Placebo

EXPERIMENTAL

Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks

Drug: Placebo

Interventions

PamrevlumabDRUG

Sterile liquid for injection

Also known as: FG-3019
Pamrevlumab
PlaceboDRUG

Sterile liquid for injection

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Center

Detroit, Michigan, 48202, United States

Location

Research Center

Greensboro, North Carolina, 27403, United States

Location

Research Center

Philadelphia, Pennsylvania, 19107, United States

Location

Research Center

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Interventions

pamrevlumab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Due to early termination of this study, formal analyses of the primary and secondary endpoints are not presented because the study's sample size is substantially underpowered for meaningful interpretation.

Results Point of Contact

Title
Clinical Trial Information Desk
Organization
FibroGen, Inc.
jcharpentier@fibrogen.com
415-978-1346

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Proof-of-concept
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 16, 2020

Study Start

June 20, 2020

Primary Completion

March 22, 2021

Study Completion

March 22, 2021

Last Updated

July 18, 2022

Results First Posted

July 18, 2022

Record last verified: 2022-06

Locations

US(4)