Pirfenidone in Adult Hospitalized Patients With COVID-19

COVID-19 Pneumonia Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05713292
• Other study ID #: CAP-China Pirfenidone
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 30, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: February 2023
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: March 30, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia

Intervention

Drug:
• Pirfenidone Oral Product
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
• Pirfenidone placebo
Pirfenidone placebo

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection	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	3 months
Secondary	distance walked in 6 Minutes (6MWD)	the difference between intervention group and placebo group	at the 3 months follow-up vist
Secondary	the EuroQol five-dimension five-level (EQ-5D-5L)	the difference between intervention group and placebo group	at the 3 months follow-up vist
Secondary	Medical Research Council (mMRC) dyspnoea scale	the difference of mMRC score between intervention group and placebo group	at the 3 months follow-up vist
Secondary	difference of forced vital capacity (FVC) between two groups	the difference of actual and predicted value between intervention group and placebo group	at the 3 months follow-up vist
Secondary	difference of total lung capacity (TLC) between two groups	the difference of actual and predicted value between intervention group and placebo group	at the 3 months follow-up vist
Secondary	difference of DLCO between two groups	the difference of actual and predicted value between intervention group and placebo group	at the 3 months follow-up vist
Secondary	incidence of adverse event	the difference of adverse event frequency between intervention group and placebo group	within 2 months after enrollment