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

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ClinicalTrials.gov Identifier: NCT04607928
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Molina, Institut d'Investigació Biomèdica de Bellvitge

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

Condition or disease Intervention/treatment Phase
Fibrotic Pulmonary Sequelae Post-COVID19 Infection Drug: Pirfenidone Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:1 (treatment:placebo)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: doble blinded, IVRSystem
Primary Purpose: Prevention
Official Title: Phase-II Randomized Clinical Trial to Evaluate the Effect of Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

Arm Intervention/treatment
Placebo Comparator: Placebo
No anti-fibrotic treatment. Patients in placebo and treatment arm may be on corticosteroid treatment
Drug: Placebo
Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection

Experimental: Treatment
Pirfenidone
Drug: Pirfenidone
Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection




Primary Outcome Measures :
  1. To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection [ Time Frame: 24 weeks ]

    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


Secondary Outcome Measures :
  1. Maintenance of stability or functional improvement FVC [ Time Frame: 24 weeks ]
    Number of patients who show maintenance of stability or functional improvement: stability will be considered when the FVC does not increase more than 10% or does not decrease more than 10% and the DLCO does not increase more than 15% or decreases more than 15%. An increase in% FVC greater than 10% or in DLCO greater than 15% will be considered significant improvement.

  2. Decreased oxygen requirement for physical activity [ Time Frame: 24 weeks ]
    Rate of decreased oxygen requirement for physical activity in patients

  3. Improved exercise capacity (> 50 meter improvement or less decrease in% oxygen saturation) in the TM6m [ Time Frame: 24 weeks ]
    Number of patients who have improved exercise capacity (> 50 meter improvement or less decrease in% oxygen saturation) in the TM6m

  4. Hospitalizations (general and due to respiratory problems) [ Time Frame: 24 weeks ]
    Number of Hospitalizations (general and due to respiratory problems)

  5. Visits to the Emergency or Day Hospital for respiratory causes [ Time Frame: 24 weeks ]
    Number of Visits to the Emergency or Day Hospital for respiratory causes

  6. Lung transplantation [ Time Frame: 24 weeks ]
    Number of patients who need Lung transplantation

  7. Death [ Time Frame: 24 weeks ]
    Number of patients who die



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607928


Contacts
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Contact: Guadalupe Bermudo, MD, PhD 00342607689 ufip@bellvitgehospital.cat

Locations
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Spain
University Hospital of Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Guadalupe Bermudo, PI    0034 932607689    lupebermudope@gmail.com   
Principal Investigator: Claudia Valenzuela, PI         
Principal Investigator: Rosalia Laporta, PI         
Principal Investigator: Juan Rigual, PI         
Principal Investigator: Diego Castillo, PI         
Principal Investigator: Jacobo Sellarés, PI         
Principal Investigator: Karina Portillo, PI         
Principal Investigator: Eva Balcells, PI         
Hospital Germans Trias i Pujol Active, not recruiting
Badalona, Spain
Hospital Clínic Active, not recruiting
Barcelona, Spain
Hospital del Mar Active, not recruiting
Barcelona, Spain
Hospital Sant Pau Not yet recruiting
Barcelona, Spain
Contact: Diego Castillo, PI         
Hospital La Princes Active, not recruiting
Madrid, Spain
Hospital Puerta de Hierro Not yet recruiting
Madrid, Spain
Contact: Piedad Usetti, MD, PhD         
Hospital Ramón y Cajal Not yet recruiting
Madrid, Spain
Contact: David Jimenez, MD, PhD         
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Bellvitge
Investigators
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Study Chair: Maria Molina-Molina, MD, PhD Institut d'Investigació Biomèdica de Bellvitge
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Responsible Party: Maria Molina, Coordinating Investigator, Institut d'Investigació Biomèdica de Bellvitge
ClinicalTrials.gov Identifier: NCT04607928    
Other Study ID Numbers: 2020-002518-42
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents