Pirfenidone in Adult Hospitalized Patients With COVID-19

Capital Medical University168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

168

Conditions

COVID-19 Pneumonia

Interventions

Pirfenidone Oral ProductDRUG

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

Pirfenidone placeboDRUG

Pirfenidone placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: 1 month