Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease

Study Overview
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Brief Summary
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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.

Official Title
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Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease

Conditions
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Covid19, COVID-19 Pneumonia, Interstitial Lung Disease

Intervention / Treatment
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* Drug: Methylprednisolone Tablet


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid<br>Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks; followed by a gradual reduction of 25% every 2 weeks. Total Duration:12-16 weeks | Drug: Methylprednisolone Tablet<br>* Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks<br>* Other names: Prednol;|
| Other: control<br>standard symptom-relief therapy (since there is no current standard therapy for post-COVID Interstitial Lung Disease, patients in this arm will be commenced symptom-relief therapies including bronchodilators, inhaled corticosteroids, non-steroid anti-inflammatories, cough relievers, and long-term oxygen if the patient has respiratory failure) | Drug: Methylprednisolone Tablet<br>* Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks<br>* Other names: Prednol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with clinical improvement | Clinical improvement is identified as grade 0 modified Medical Research Council (mMRC) dyspnea score with no respiratory complaints. | 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% | 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.) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of diffusion capacity of lung for carbon monoxide (DLCO) | Percentage of increase in diffusion capacity of lung for carbon monoxide | 12 weeks | 
| Improvement of Forced Vital Capacity (FVC) | Change in Forced Vital Capacity | 12 weeks | 
| Improvement of arterial oxygen saturation (SaO2) | Change in Oxygen Saturation at room air | 12 weeks | 
| Improvement of Exercise Capacity | Change in 6 minute walking test duration | 12 weeks | 
| Improvement of mMRC dyspnea score | Change in mMRC dyspnea score | 12 weeks | 
| Respiratory-cause emergency visit and hospitalisation | Number of patients who had respiratory-cause emergency visit and hospitalization during study period. | 12 weeks | 
| Mortality rate | Mortality rate | 12 weeks | 
| Advers events | Systemic corticosteroid related advers events | 12 weeks |