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Active Not Recruiting
NCT05713292
Pirfenidone in Adult Hospitalized Patients With COVID-19
Conditions: COVID-19 Pneumonia
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 168
Sponsor: Capital Medical University
Location: China
Summary
This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
Eligibility Criteria
Inclusion Criteria:Subjects Age ≥ 18 Willing and able to provide written informed consentSARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologiesTime of illness onset ≥8 daysHave findings consistent with interstitial lung disease found on CT scanWilling not use other investigational agents of anti-fibrosisExclusion Criteria:Pre-existing severe liver diseasePre-existing severe chronic kidney diseasePre-existing interstitial lung diseasePre-existing severe COPD or other structural lung diseaseReceiving invasive mechanical ventilationCurrently Pregnant or Breast FeedingPoor baseline health conditoinDisability to complete lung function testReceiving pirfenidone wthin half-year
Source: ClinicalTrials.gov (NCT05713292). StuddyBuddy aggregates publicly available trial information.