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Column | Value |
---|---|
Trial registration number | NCT04988282 |
Full text link
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Oct. 27, 2022, 8 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : Oct. 27, 2022, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
Registration date
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
2021-08-03 |
Recruitment status
Last imported at : Oct. 27, 2022, 8 a.m. Source : ClinicalTrials.gov |
Completed |
Study design
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Long covid |
Inclusion criteria
Last imported at : Oct. 12, 2023, 4 a.m. Source : ClinicalTrials.gov |
inclusion criteria: post-covid-19 interstitial lung disease (ild) patients who had completed the treatment of acute phase and have recovered, but despite after 90 days from recovery diagnosed as post-covid ild based upon the persistent respiratory symptoms with functional impairment and radiological sequela. at least 90 days required after discharge for hospitalized patients or termination of isolation for outpatients confirmation of the diagnosis of covid-19 via real time polymerase chain reaction assay (rt-pcr) or antigen or antibody test in the acute phase of covid-19. presence of sequelae interstitial changes in follow-up (pre-enrollment) thorax high-resolution computed tomography (hrct)/ct. presence of persistent respiratory symptoms in the post-covid-19 period or hypoxemia at rest and/or desaturation with exercise. |
Exclusion criteria
Last imported at : Oct. 12, 2023, 4 a.m. Source : ClinicalTrials.gov |
patients who had a normal lung imaging examination (radiography, tomography, etc.) at discharge or enrollment phase pre-existing diffuse parenchymal lung disease before pandemic cystic bronchiectasis presence of contraindications for systemic corticosteroids (uncontrolled diabetes, uncontrolled hypertension, unstable angina pectoris, history of acute coronary syndrome at last month, presence of active infection, active peptic ulcer, presence of uncontrolled psychiatric disease, etc.) decompensated heart failure contraindications for pulmonary function tests and those who cannot cooperate with the test younger than 18 years old pregnant women breastfeeding women those who do not give written consent |
Number of arms
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Turkish Thoracic Society |
Inclusion age min
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Turkey |
Type of patients
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
Severity scale
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : Oct. 27, 2022, 8 a.m. Source : ClinicalTrials.gov |
262 |
primary outcome
Last imported at : Oct. 12, 2023, 4 a.m. Source : ClinicalTrials.gov |
% of patients with clinical improvement;% of patients with functional improvement;% of patients with radiological improvement |
Notes
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Phase 4 |
Arms
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |