Pirfenidone in Post COVID lung disease: Randomised controlled study

Phase 3

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

Registration Number: CTRI/2021/09/036442

Lead Sponsor: Sryma PB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Signed Informed Consent Form

Ability to comply with the study protocol in the opinion of the Investigator

Confirmation of SARS-COV2 infection in previous weeks

HRCT with radiological changes showing predominant fibrotic changes (comprising more than 50 % of the abnormal lung) after recovery from the acute process (HRCT chest during the screening period, performed minimum after 4 weeks of onset of illness and maximum 12 weeks post onset of illness)

Oxygen saturation of < 95% at rest OR exertional desaturation of >3% on six-minute walk test

Exclusion Criteria

Current use of systemic steroids (oral or intravenous)

Pulmonary embolism requiring anticoagulation during the study period

Invasive fungal infections requiring systemic antifungal treatments

Severe or life-limiting chronic disease prior to COVID19 infection, including severe asthma, COPD, cancer, clinical dementia, IPF, or uncontrolled ischemic cardiomyopathy.

Treatment with pirfenidone or nintedanib prior to Covid19

Active smoking.

Pregnancy or lactation

Relevant blood alterations in the analysis made during the screening period:

Total bilirubin > 2 ULN

AST/SGOT or ALT/SGPT > 2.5 ULN

Alkaline phosphatase >3.0 ULN

Creatinine Clearance <40 mL/min, calculated by the Cockcroft-Gault formula

Concomitant treatments that can cause severe digestive problems, Gastric surgery in the last 3 months or similar procedures that may increase gastric intolerance

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection analyzed by <br/ ><br>oChange from Baseline in % in forced vital capacity (FVC) <br/ ><br>oChange from Baseline % fibrosis in high resolution computed tomography (HRCT) of the lung <br/ ><br>Timepoint: baseline and at 3 months

Secondary Outcome Measures

Name	Time	Method
1.Improved exercise capacity (50-meter improvement or less decrease in% oxygen saturation) in the 6 minute walk distance <br/ ><br>2.Hospitalizations <br/ ><br>3.Death <br/ ><br>4.Maintenance of stability or functional improvement in FVC <br/ ><br>5.Change in severity of fatigue and breathlessness as median change in VAS (Visual analog scale) for fatigue and breathlessness <br/ ><br>6.Compare the evolution of dyspnea over time mMRC score <br/ ><br>7.Decreased oxygen requirement for physical activity <br/ ><br>8.Safety of pirfenidone <br/ ><br> <br/ ><br>Timepoint: Baseline and at 3 months