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

NCT04607928 | Unknown Phase 2 DMC

• 1 other identifier: 2020-002518-42
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Fibrotic Pulmonary Sequelae Post-COVID19 Infection

Outcome Measures

Primary Outcomes (1)

• To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection

  To investigate the effect of pirfenidone administered for 24 weeks measuring the number of patients who have pulmonary fibrotic changes from baseline after suffering severe COVID19 pneumonia, analysed by * Change From Baseline in % in forced vital capacity (FVC) * Change From Baseline % fibrosis in high resolution computed tomography (HRCT) of the lung

  24 weeks

Secondary Outcomes (7)

• Maintenance of stability or functional improvement FVC

  24 weeks

• Decreased oxygen requirement for physical activity

  24 weeks

• Improved exercise capacity (> 50 meter improvement or less decrease in% oxygen saturation) in the TM6m

  24 weeks

• Hospitalizations (general and due to respiratory problems)

  24 weeks

• Visits to the Emergency or Day Hospital for respiratory causes

  24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

No anti-fibrotic treatment. Patients in placebo and treatment arm may be on corticosteroid treatment

Drug: Placebo

Treatment

EXPERIMENTAL

Pirfenidone

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection

Treatment

Placebo DRUG

Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead

Study Sites (8)

University Hospital of Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Germans Trias i Pujol

Badalona, Spain

ACTIVE NOT RECRUITING

Hospital Clínic

Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital del Mar

Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital La Princes

Madrid, Spain

ACTIVE NOT RECRUITING

Hospital Puerta de Hierro

Madrid, Spain

NOT YET RECRUITING

Hospital Ramón y Cajal

Madrid, Spain

NOT YET RECRUITING

MeSH Terms

Interventions

pirfenidone

Study Officials

• Maria Molina-Molina, MD, PhD

  Institut d'Investigació Biomèdica de Bellvitge

  STUDY CHAIR

Central Study Contacts

Guadalupe Bermudo, MD, PhD

CONTACT

00342607689; ufip@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: doble blinded, IVRSystem
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: 2:1 (treatment:placebo)

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: October 29, 2020
• Study Start: August 1, 2020
• Primary Completion: January 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)