Pirfenidone in Post COVID-19 lung fibrosis treatment(PirfeCT): a pilot randomised study - PirfeCT

Sryma PB0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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

发起方

Sryma PB