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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Drug: Pirfenidone Oral Product; Drug: Pirfenidone placebo

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pirfenidone; Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months	Drug: Pirfenidone Oral Product; Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
PLACEBO_COMPARATOR: Placebo; Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months	Drug: Pirfenidone placebo; Pirfenidone placebo

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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2022
• Primary Completion (ANTICIPATED): March 2, 2023
• Study Completion (ANTICIPATED): March 30, 2023

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: CAP-China Pirfenidone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No