Status:
UNKNOWN
Pirfenidone vs. Nintedanib for Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Novel Coronavirus-induced Lung Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 tr...
Detailed Description
Since the early part of 2020, the entire world has been affected by a pandemic of the coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04856111
Start Date
March 17 2021
End Date
November 30 2022
Last Update
October 3 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Postgraduate Institute of Medical Education and Research
Chandigarh, India