Pirfenidone in Adult Hospitalized Patients With COVID-19

Sponsor

Capital Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05713292

Collaborator

(none)

168

Enrollment

Location

Arms

Anticipated Duration (Months)

56.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Drug: Pirfenidone Oral Product Drug: Pirfenidone placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Dec 30, 2022

Anticipated Primary Completion Date :

Mar 2, 2023

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection [3 months]
DLCO at 1 month and 3 months follow up after enrollment TLC at 1 month and 3 months follow up after enrollment Change in Chest CT Severity Scoring (Chest CT-SS) from 1 month to 3 months follow up after enrollment compared to baseline CT Chest scan

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China-Japan Friendship Hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bin Cao, Capital Medical University, Capital Medical University

ClinicalTrials.gov Identifier:

NCT05713292

Other Study ID Numbers:

CAP-China Pirfenidone

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Pirfenidone

Study Results

No Results Posted as of Feb 6, 2023