Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Pirfenidone: Tablets will be started at 267mg thrice daily orally for first week. If tolerating, dose will be increased to 801mg twice daily orally in second week and to 801mg thrice da
Sponsors
Sryma PB
Eligibility
Inclusion criteria
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 3% on six-minute walk test
Exclusion criteria
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 Concomitant treatments that can cause severe digestive problems, Gastric surgery in the last 3 months or similar procedures that may increase gastric intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection analyzed by oChange from Baseline in % in forced vital capacity (FVC) oChange from Baseline % fibrosis in high resolution computed tomography (HRCT) of the lung Timepoint: baseline and at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improved exercise capacity (50-meter improvement or less decrease in% oxygen saturation) in the 6 minute walk distance 2.Hospitalizations 3.Death 4.Maintenance of stability or functional improvement in FVC 5.Change in severity of fatigue and breathlessness as median change in VAS (Visual analog scale) for fatigue and breathlessness 6.Compare the evolution of dyspnea over time mMRC score 7.Decreased oxygen requirement for physical activity 8.Safety of pirfenidone Timepoint: Baseline and at 3 months | — |
Countries
India
Contacts
Public ContactSryma PB
PSGIMSR, Peelamedu
Outcome results
None listed