Pirfenidone in Adult Hospitalized Patients With COVID-19
- Conditions
- COVID-19 Pneumonia
- Interventions
- Registration Number
- NCT05713292
- Lead Sponsor
- Capital Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Pirfenidone placebo Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months Pirfenidone Pirfenidone Oral Product Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
- Primary Outcome Measures
Name Time Method To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection 1 month 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
- Secondary Outcome Measures
Name Time Method difference of DLCO between two groups at the 3 months follow-up vist the difference of actual and predicted value between intervention group and placebo group
incidence of adverse event within 2 months after enrollment the difference of adverse event frequency between intervention group and placebo group
difference of total lung capacity (TLC) between two groups at the 1 month and 3 months follow-up vist the difference of actual and predicted value between intervention group and placebo group
Medical Research Council (mMRC) dyspnoea scale at the 1 month and 3 months follow-up vist the difference of mMRC score between intervention group and placebo group
distance walked in 6 Minutes (6MWD) at the 1 month and 3 months follow-up vist the difference between intervention group and placebo group
the EuroQol five-dimension five-level (EQ-5D-5L) at the 1 month and 3 months follow-up vist the difference between intervention group and placebo group
difference of forced vital capacity (FVC) between two groups at the 1 month and 3 months follow-up vist the difference of actual and predicted value between intervention group and placebo group
Trial Locations
- Locations (1)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China