Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis COVID-19

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Study population: Patients with fibrotic lung sequelae after recovery from acute phase of severe COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administered for 24 weeks in patients who have pulmonary fibrotic changes after suffering severe COVID19 pneumonia, analysed by

• % change in forced vital capacity (FVC)

• % fibrosis in high resolution computed tomography (HRCT) of the lung

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut d'Investigació Biomèdica de Bellvitge
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

• Age > 18 years

• 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 (Confirmation of negativity or no activity of SARS-COV2 before randomization using the usual tests performed in the hospital), which induced severe pneumonia and ARDS, with subsequent torpid recovery and/or incipient clinical-radiological signs of pulmonary fibrosis.

• HRCT with fibrotic radiological changes of at least 5% after recovery from the acute process (HRCT chest during the screening period, performed minimum after 1 month of the acute phase and maximum 90 days after hospital discharge)

• Be able to understand the information given and sign the informed consent

• For women or men of childbearing age who are not sterile, a commitment to use non-hormonal contraception during the 24-week treatment period will be required.

Exclusion Criteria:

• Use of systemic steroids (oral or intravenous) at doses greater than 15 mg/day one month prior to randomisation.

• Severe or moderate myopathy that may associate a decrease of FVC.

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

• Treatment with pirfenidone or nintedanib prior to Covid19

• Concomitant treatment with significant interactions with pirfenidone (such as fluvoxamine).

• Participation in any other investigational trial throughout the study

• Active smoking.

• 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

• Pregnancy or lactation

• Concomitant treatments that can cause severe digestive problems.

• Gastric surgery in the last 3 months or similar procedures that may increase gastric intolerance.

• Inability to complete required visits.

• Previous intolerance or allergy to pirfenidone or hypersensitivity to any of its excipients.

• History of angioedema