EVALUATING THE EFFECT OF PIRFENIDONE COMPARED WITH PLACEBO IN PULMONARY FIBROSIS POST-COVID 19

Phase 1

• Conditions: Pulmonary fibrosis induced by SARS-COV2 virus (post-COVID19 pulmonary sequelae); MedDRA version: 21.0Level: PTClassification code 10037383Term: Pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 23.0Level: HLTClassification code 10084510Term: Coronavirus infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002518-42-ES
• Lead Sponsor: IDIBE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-28
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 148

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 (with negative PCR at study entry), 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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:
o Total bilirubin > 2 ULN
o AST/SGOT or ALT/SGPT > 2.5 ULN
o Alkaline phosphatase >3.0 ULN
o 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified