Pirfenidone in Adult Hospitalized Patients With COVID-19

Study Overview
=================
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.

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.

Conditions
-----------------
COVID-19 Pneumonia

Intervention / Treatment
-----------------
* Drug: Pirfenidone Oral Product
* Drug: Pirfenidone placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pirfenidone<br>Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months | Drug: Pirfenidone Oral Product<br>* Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months<br>|
| Placebo Comparator: Placebo<br>Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months | Drug: Pirfenidone placebo<br>* Pirfenidone placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distance walked in 6 Minutes (6MWD) | the difference between intervention group and placebo group | at the 3 months follow-up vist | 
| the EuroQol five-dimension five-level (EQ-5D-5L) | the difference between intervention group and placebo group | at the 3 months follow-up vist | 
| Medical Research Council (mMRC) dyspnoea scale | the difference of mMRC score between intervention group and placebo group | at the 3 months follow-up vist | 
| difference of forced vital capacity (FVC) between two groups | the difference of actual and predicted value between intervention group and placebo group | at the 3 months follow-up vist | 
| difference of total lung capacity (TLC) between two groups | the difference of actual and predicted value between intervention group and placebo group | at the 3 months follow-up vist | 
| difference of DLCO between two groups | the difference of actual and predicted value between intervention group and placebo group | at the 3 months follow-up vist | 
| incidence of adverse event | the difference of adverse event frequency between intervention group and placebo group | within 2 months after enrollment |