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Pirfenidone vs Nintedanib in Post-COVID Lung Fibrosis

NCT04856111Phase 4

Key facts

Status: Unknown
Start: Mar 2021
Primary completion: Nov 2022
Countries: 1
Sponsor: Post Graduate Institute of Medical Education and Research
Modality: Small Molecules

Drugs: pirfenidone
Conditions: pulmonary fibrosis (PF)

Overview

Phase 4, randomised, single-blind trial of pirfenidone in pulmonary fibrosis (PF) (2 arms), sponsored by Post Graduate Institute of Medical Education and Research. Primary endpoint: Change in Forced Vital Capacity at 24 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedSingle-blind

Pirfenidone
Pirfenidone 600 mg/day escalated to 2400 mg/day
Nintedanib
Nintedanib 150 mg twice daily

Who it enrols

Adult patients with post-COVID-19 lung fibrosis (>10% parenchymal involvement) and persistent respiratory symptoms despite glucocorticoid treatment.

Endpoints

Primary

Change in Forced Vital Capacity24 weeks

Secondary

Proportion of subjects with improvement or stabilization24 weeks
Proportion of subjects with a good composite response24 weeks
Change in dyspnea score on modified Medical Research Council scale24 weeks
Severity of dyspnea on the Functional Assessment of Chronic Illness Therapy - Dyspnea-10 item scale24 weeks
Change in resting oxygen saturation24 weeks
Proportion of subjects with oxygen desaturation on exercise testing24 weeks
Percentage change in the six-minute walk distance24 weeks
Proportion of participants who need rescue treatment24 weeks

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