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Pirfenidone in Adult Hospitalized Patients With COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Pirfenidone in Adult Hospitalized Patients With COVID-19

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.

NCT05713292•Capital Medical University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects Age ≥ 18 Willing and able to provide written informed consent
•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 liver disease
•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

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 1, 2022

Primary Completion Date

March 4, 2023

Completion Date

March 30, 2023

Last Updated

July 3, 2024

Enrollment

168

ACTUAL participants

Conditions

COVID-19 Pneumonia

Interventions

Pirfenidone Oral Product

DRUG

Pirfenidone placebo

DRUG

Corona Virus Disease 2019 Cohort Study

NCT06927622

COVID-19 PneumoniaCOVID-19 Pandemic+1 more

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COMPLETEDNA

HRQOL of Life After ECMO Due to COVID-19.

NCT05531032

ARDSCOVID-19 Pneumonia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pirfenidone in Adult Hospitalized Patients With COVID-19

Inclusion Criteria

Exclusion Criteria

Corona Virus Disease 2019 Cohort Study

HRQOL of Life After ECMO Due to COVID-19.

Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)

Cerebral Autoregulation and COVID-19

Cromolyn Sodium for Treatment of COVID-19 Pneumonia

Tele-rehabilitation Program After Hospitalization for COVID-19