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| Column | Value |
|---|---|
| Trial registration number | NCT04856111 |
|
Full text link
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 4, 2022, 7 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Oct. 4, 2022, 7 a.m. Source : ClinicalTrials.gov |
None |
|
Registration date
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-04-22 |
|
Recruitment status
Last imported at : Oct. 4, 2022, 7 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: 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 criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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 |
|
Number of arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Postgraduate Institute of Medical Education and Research |
|
Inclusion age min
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
India |
|
Type of patients
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
48 |
|
primary outcome
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Change in the forced vital capacity (FVC) |
|
Notes
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 995, "treatment_name": "Pirfenidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 887, "treatment_name": "Nintedanib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}] |