Pirfenidone for COVID-19 related lung fibrosis

Phase 3

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2021/03/032199

Lead Sponsor: Anant Mohan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. History of COVID-19 illness diagnosed by RT-PCR/Rapid antigen/ Truenaat of throat or nasopharyngeal swab at least 8 weeks prior

2. Having persistent respiratory symptoms (cough and breathlessness) or persistent hypoxemia (SpO2 <94% on room air) or oxygen desaturation on exercise

AND

Has evidence of pulmonary fibrosis on HRCT thorax (at least 15% involvement by visual semi-quantitative assessment) performed at least 8 weeks after COVID-19 diagnosis

3. Provides written informed consent for evaluation and treatment as per study protocol

Exclusion Criteria

1. Patients not providing consent for participation in the study

2. FEV1/FVC ratio < 0.80

3. Active smokers

4. Any active malignancy/ malignancy within past 2 years

5. Severe hepatic impairment

6. Use of immunosuppressant drugs (except corticosteroids and tocilizumab) within last 6 weeks

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in Forced Vital Capacity (FVC) (% predicted) at 6 months following treatment initiation with oral Pirfenidone versus placebo in patients with COVID-19 associated pulmonary fibrosisTimepoint: at 6 months

Secondary Outcome Measures

Name	Time	Method
To assess change in diffusion capacity for carbon mono-oxide (DLCO) at 3 and 6 monthsTimepoint: at 3 and 6 months;To assess change in total lung capacity at 3 and 6 monthsTimepoint: at 3 and 6 months;To Assess the adverse events during therapyTimepoint: at 6 months;To assess the change in extent of lung involvement on high resolution computed tomography (HRCT) thorax at 3 monthsTimepoint: at 3 months;To assess the difference in Six minute walk distance at 3 and 6 months among the groupsTimepoint: at 3 and 6 months;To compare the change in dyspnea on modified borg dyspnea scaleTimepoint: at 6 months;To compare the change in FVC at 3 months among the groupsTimepoint: at 3 months