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| Column | Value |
|---|---|
| Trial registration number | NCT04607928 |
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Full text link
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
ufip@bellvitgehospital.cat |
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Registration date
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-10-29 |
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Recruitment status
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Long covid |
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Inclusion criteria
Last imported at : Nov. 6, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- 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 |
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Number of arms
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Institut d'Investigació Biomèdica de Bellvitge |
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Inclusion age min
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Spain |
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Type of patients
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
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Severity scale
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
148 |
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primary outcome
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection |
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Notes
Last imported at : Oct. 30, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Nov. 4, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 995, "treatment_name": "Pirfenidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |