Pirfenidone in Adult Hospitalized Patients With COVID-19
NCT ID: NCT05713292
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2022-12-01
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pirfenidone
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Pirfenidone Oral Product
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Placebo
Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months
Pirfenidone placebo
Pirfenidone placebo
Interventions
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Pirfenidone Oral Product
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Pirfenidone placebo
Pirfenidone placebo
Eligibility Criteria
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Inclusion Criteria
* SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
* Time of illness onset ≥8 days
* Have findings consistent with interstitial lung disease found on CT scan
* Willing not use other investigational agents of anti-fibrosis
Exclusion Criteria
* Pre-existing severe chronic kidney disease
* Pre-existing interstitial lung disease
* Pre-existing severe COPD or other structural lung disease
* Receiving invasive mechanical ventilation
* Currently Pregnant or Breast Feeding
* Poor baseline health conditoin
* Disability to complete lung function test
* Receiving pirfenidone wthin half-year
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Bin Cao
Capital Medical University
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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CAP-China Pirfenidone
Identifier Type: -
Identifier Source: org_study_id
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