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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid | Active Comparator | Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks; followed by a gradual reduction of 25% every 2 weeks. Total Duration:12-16 weeks |
|
| control | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone Tablet | Drug | Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks |
|
| 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 |
| 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) |
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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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| METİN AKGÜN | ATATURK UNIVERSITY FACULTY OF MEDICINE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ufuk University Medicine Faculty | Ankara | 06520 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |