Pirfenidone in Adult Hospitalized Patients With COVID-19

NCT ID: NCT05713292

Last Updated: 2024-07-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pirfenidone

Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months

Group Type EXPERIMENTAL

Pirfenidone Oral Product

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Pirfenidone placebo

Intervention Type DRUG

Pirfenidone placebo

Interventions

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Pirfenidone Oral Product

Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months

Intervention Type DRUG

Pirfenidone placebo

Pirfenidone placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Bin Cao

Capital Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CAP-China Pirfenidone

Identifier Type: -

Identifier Source: org_study_id

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