Pirfenidone in Adult Hospitalized Patients With COVID-19

NCT05713292 | Completed Phase 3

• 1 other identifier: CAP-China Pirfenidone
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection

  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 Outcomes (7)

• distance walked in 6 Minutes (6MWD)

  at the 1 month and 3 months follow-up vist

• the EuroQol five-dimension five-level (EQ-5D-5L)

  at the 1 month and 3 months follow-up vist

• Medical Research Council (mMRC) dyspnoea scale

  at the 1 month and 3 months follow-up vist

• difference of forced vital capacity (FVC) between two groups

  at the 1 month and 3 months follow-up vist

• difference of total lung capacity (TLC) between two groups

  at the 1 month and 3 months follow-up vist

Study Arms (2)

Pirfenidone

EXPERIMENTAL

Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months

Drug: Pirfenidone Oral Product

Placebo

PLACEBO COMPARATOR

Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months

Drug: Pirfenidone placebo

Interventions

Pirfenidone Oral Product DRUG

Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months

Pirfenidone

Pirfenidone placebo DRUG

Pirfenidone placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Capital Medical University

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: February 6, 2023
• Study Start: December 1, 2022
• Primary Completion: March 4, 2023
• Study Completion: March 30, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

CN (1)