Pirfenidone in Adult Hospitalized Patients With COVID-19

June 29, 2024 updated by: Bin Cao, Capital Medical University

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.

This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects Age ≥ 18 Willing and able to provide written informed consent
  • SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
  • Time of illness onset ≥8 days
  • Have findings consistent with interstitial lung disease found on CT scan
  • Willing not use other investigational agents of anti-fibrosis

Exclusion Criteria:

  • Pre-existing severe liver disease
  • Pre-existing severe chronic kidney disease
  • Pre-existing interstitial lung disease
  • Pre-existing severe COPD or other structural lung disease
  • Receiving invasive mechanical ventilation
  • Currently Pregnant or Breast Feeding
  • Poor baseline health conditoin
  • Disability to complete lung function test
  • Receiving pirfenidone wthin half-year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pirfenidone
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Drug: Pirfenidone Oral Product
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Placebo Comparator: Placebo
Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months
Drug: Pirfenidone placebo
Pirfenidone placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
Time Frame: 1 month
  1. Change of total lung lesion volume on Chest CT from enrollment to 1 month follow up
  2. DLCO% pred at 1 month follow up
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of DLCO between two groups
Time Frame: at the 3 months follow-up vist
the difference of actual and predicted value between intervention group and placebo group
at the 3 months follow-up vist
incidence of adverse event
Time Frame: within 2 months after enrollment
the difference of adverse event frequency between intervention group and placebo group
within 2 months after enrollment
distance walked in 6 Minutes (6MWD)
Time Frame: at the 1 month and 3 months follow-up vist
the difference between intervention group and placebo group
at the 1 month and 3 months follow-up vist
the EuroQol five-dimension five-level (EQ-5D-5L)
Time Frame: at the 1 month and 3 months follow-up vist
the difference between intervention group and placebo group
at the 1 month and 3 months follow-up vist
Medical Research Council (mMRC) dyspnoea scale
Time Frame: at the 1 month and 3 months follow-up vist
the difference of mMRC score between intervention group and placebo group
at the 1 month and 3 months follow-up vist
difference of forced vital capacity (FVC) between two groups
Time Frame: at the 1 month and 3 months follow-up vist
the difference of actual and predicted value between intervention group and placebo group
at the 1 month and 3 months follow-up vist
difference of total lung capacity (TLC) between two groups
Time Frame: at the 1 month and 3 months follow-up vist
the difference of actual and predicted value between intervention group and placebo group
at the 1 month and 3 months follow-up vist

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

March 4, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 29, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP-China Pirfenidone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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