Pirfenidone vs. Nintedanib for Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia

NCT04856111 | Unknown Phase 4

• 1 other identifier: INT/IEC/2021/SPL-462
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The antifibrotic agents, namely pirfenidone and nintedanib have been found to be effective in the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib has also been found to be effective in treating systemic sclerosis-related interstitial lung disease (ILD) and non-IPF progressive fibrosing ILDs. Pirfenidone has also been found beneficial unclassifiable ILDs. Whether these drugs would be effective in treating post-COVID lung fibrosis also is unknown. As the final pathway of lung fibrosis appears to be common among different diffuse parenchymal lung diseases (DPLDs), it is hoped that these antifibrotic agents might be helpful in post-COVID fibrosis. There are no randomized studies that have assessed the role of pirfenidone or nintedanib in post COVID fibrosis. In the current study, we aim to assess the efficacy and safety of pirfenidone and compare it with nintedanib in the treatment of post-COVID lung fibrosis.

Conditions

Novel Coronavirus-induced Lung Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in the forced vital capacity (FVC)

  Forced vital capacity will be measured using spirometry. The predicted value will be calculated based on standard reference equations.

  24 weeks

Secondary Outcomes (13)

• Proportion of subjects with improvement or stabilization

  24 weeks

• Proportion of subjects with a good composite response

  24 weeks

• Change in dyspnea score on modified Medical Research Council scale

  24 weeks

• Severity of dyspnea on the Functional Assessment of Chronic Illness Therapy - Dyspnea-10 item scale

  24 weeks

• Change in resting oxygen saturation

  24 weeks

Study Arms (2)

Pirfenidone

ACTIVE COMPARATOR

Pirfenidone will be started at a dose of 600 mg/day. The dose will be escalated by 600 mg/day every 3-7 days up to a targeted dose of 2400 mg/day. The subjects will be administered the maximum tolerated dose for a total period of 24 weeks from randomization.

Drug: Pirfenidone

Nintedanib

ACTIVE COMPARATOR

Subjects in this group will be administered nintedanib at a dose of 150 mg twice daily. The liver function tests will be monitored as above. The dose will be reduced to 100 mg twice daily, if there is intolerance to 300 mg/day dose.

Drug: Nintedanib

Interventions

Pirfenidone DRUG

Same as arm description

Pirfenidone

Nintedanib DRUG

Same as arm description

Nintedanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Diagnosed to have COVID-19 by means of a real-time reverse transcription polymerase chain reaction (rRT-PCR) test performed on a respiratory (upper or lower respiratory) sample or positive IgM antibody test or a rapid antigen test with consistent clinicoradiologic findings within the previous 4 months
• Persistent respiratory symptoms
• Having post-COVID parenchymal involvement \>10% of the lung parenchyma on visual inspection of the scans with the presence of radiologic signs of fibrosis (traction bronchiectasis/traction bronchiolectasis or honeycombing or reduced lung volumes), or having persistent reticulation or persistent consolidation despite a trial of glucocorticoids (minimum prednisolone dose of 10 mg/day, or equivalent) for a minimum period of 4 weeks after discharge for the acute COVID-19 illness

You may not qualify if:

• Pregnant or lactating women
• Having absolute contraindication for pirfenidone or nintedanib (advanced liver cirrhosis, persistent elevation of liver transaminases, documented hypersensitivity to pirfenidone or nintedanib, receiving anticoagulants or high dose aspirin or having a vascular stent in situ)
• Known patient with diffuse lung disease prior to the diagnosis of COVID

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, India

Location

MeSH Terms

Interventions

pirfenidone; nintedanib

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: March 17, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)