Back to resultsPirfenidone in Adult Hospitalized Patients With COVID-19
Primary Purpose
COVID-19 Pneumonia
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pirfenidone Oral Product
Pirfenidone placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
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
Sites / Locations
- China-Japan Friendship Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pirfenidone
Placebo
Arm Description
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months
Outcomes
Primary Outcome Measures
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
DLCO at 1 month and 3 months follow up after enrollment
TLC at 1 month and 3 months follow up after enrollment
Change in Chest CT Severity Scoring (Chest CT-SS) from 1 month to 3 months follow up after enrollment compared to baseline CT Chest scan
Secondary Outcome Measures
distance walked in 6 Minutes (6MWD)
the difference between intervention group and placebo group
the EuroQol five-dimension five-level (EQ-5D-5L)
the difference between intervention group and placebo group
Medical Research Council (mMRC) dyspnoea scale
the difference of mMRC score between intervention group and placebo group
difference of forced vital capacity (FVC) between two groups
the difference of actual and predicted value between intervention group and placebo group
difference of total lung capacity (TLC) between two groups
the difference of actual and predicted value between intervention group and placebo group
difference of DLCO between two groups
the difference of actual and predicted value between intervention group and placebo group
incidence of adverse event
the difference of adverse event frequency between intervention group and placebo group
Full Information
NCT ID
NCT05713292
First Posted
January 1, 2023
Last Updated
February 3, 2023
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05713292
Brief Title
Pirfenidone in Adult Hospitalized Patients With COVID-19
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 30, 2022 (Actual)
Primary Completion Date
March 2, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pirfenidone
Arm Type
Experimental
Arm Description
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months
Intervention Type
Drug
Intervention Name(s)
Pirfenidone Oral Product
Intervention Description
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
Intervention Type
Drug
Intervention Name(s)
Pirfenidone placebo
Intervention Description
Pirfenidone placebo
Primary Outcome Measure Information:
Title
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
Description
DLCO at 1 month and 3 months follow up after enrollment
TLC at 1 month and 3 months follow up after enrollment
Change in Chest CT Severity Scoring (Chest CT-SS) from 1 month to 3 months follow up after enrollment compared to baseline CT Chest scan
Time Frame
3 months
Secondary Outcome Measure Information:
Title
distance walked in 6 Minutes (6MWD)
Description
the difference between intervention group and placebo group
Time Frame
at the 3 months follow-up vist
Title
the EuroQol five-dimension five-level (EQ-5D-5L)
Description
the difference between intervention group and placebo group
Time Frame
at the 3 months follow-up vist
Title
Medical Research Council (mMRC) dyspnoea scale
Description
the difference of mMRC score between intervention group and placebo group
Time Frame
at the 3 months follow-up vist
Title
difference of forced vital capacity (FVC) between two groups
Description
the difference of actual and predicted value between intervention group and placebo group
Time Frame
at the 3 months follow-up vist
Title
difference of total lung capacity (TLC) between two groups
Description
the difference of actual and predicted value between intervention group and placebo group
Time Frame
at the 3 months follow-up vist
Title
difference of DLCO between two groups
Description
the difference of actual and predicted value between intervention group and placebo group
Time Frame
at the 3 months follow-up vist
Title
incidence of adverse event
Description
the difference of adverse event frequency between intervention group and placebo group
Time Frame
within 2 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Learn more about this trial
Pirfenidone in Adult Hospitalized Patients With COVID-19
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