Pirfenidone in Adult Hospitalized Patients With COVID-19

Capital Medical University

Status and phase: Completed; Phase 3

Conditions: COVID-19 Pneumonia

Treatments: Drug: Pirfenidone Oral Product; Drug: Pirfenidone placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05713292

CAP-China Pirfenidone

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

168 participants in 2 patient groups, including a placebo group

Pirfenidone

Experimental group

Description:

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

Treatment:

Drug: Pirfenidone Oral Product

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Pirfenidone placebo