Pirfenidone in Adult Hospitalized Patients With COVID-19

• Status: Active, not recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Treatments: Pirfenidone

Criteria

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