Aim: To investigate the efficacy of systemic corticosteroids in treatment for Post-COVID-19 Interstitial Lung Disease. Method: Method: In this multi-centre, prospective, randomised controlled open label clinical trial, patients are divided into two arms: standard treatment arm and standard plus systemic corticosteroid arm. After twelve weeks; clinical, functional, and radiological improvement will being assessed as primary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
262
Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks
Ufuk University Medicine Faculty
Ankara, Turkey (Türkiye)
% of patients with clinical improvement
Clinical improvement is identified as grade 0 modified Medical Research Council (mMRC) dyspnea score with no respiratory complaints.
Time frame: 12 weeks
% of patients with functional improvement
A combination of following features: Sp02 is greater than 95% at rest; No desaturation during 6MWT; FVC is greater than 80%; DLCO is greater than 80%
Time frame: 12 weeks
% of patients with radiological improvement
At least 50% regression in extension of interstitial lesions on thorax CT. (Thorax CT images will be assessed by a radiologist and a pulmonologist who is expertised in thoracic CT.)
Time frame: 12 weeks
Improvement of diffusion capacity of lung for carbon monoxide (DLCO)
Percentage of increase in diffusion capacity of lung for carbon monoxide
Time frame: 12 weeks
Improvement of Forced Vital Capacity (FVC)
Change in Forced Vital Capacity
Time frame: 12 weeks
Improvement of arterial oxygen saturation (SaO2)
Change in Oxygen Saturation at room air
Time frame: 12 weeks
Improvement of Exercise Capacity
Change in 6 minute walking test duration
Time frame: 12 weeks
Improvement of mMRC dyspnea score
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Change in mMRC dyspnea score
Time frame: 12 weeks
Respiratory-cause emergency visit and hospitalisation
Number of patients who had respiratory-cause emergency visit and hospitalization during study period.
Time frame: 12 weeks
Mortality rate
Mortality rate
Time frame: 12 weeks
Advers events
Systemic corticosteroid related advers events
Time frame: 12 weeks