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Trial - NCT04988282


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

Not reported

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"}]