Pirfenidone for COVID-19 related lung fibrosis

Pirfenidone for coronavirus disease 2019 (COVID-19) related pulmonary fibrosis: A placebo-controlled randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032199

Enrollment

Registered

2021-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Pirfenidone tablet 800 mg three times a day: For 6 months Control Intervention1: Matched Placebo 800 mg for three times per day: For 6 months

Eligibility

Inclusion criteria

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 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

Exclusion criteria: 1. Patients not providing consent for participation in the study 2. FEV1/FVC ratio 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactAnant Mohan

All India Institute of Medical Sciences, New Delhi

anantmohan@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026