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

Phase 4

Completed

• Conditions: Covid19; COVID-19 Pneumonia; Interstitial Lung Disease
• Interventions: Drug: Methylprednisolone Tablet

• Registration Number: NCT04988282
• Lead Sponsor: Turkish Thoracic Society

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-24
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-31
• Study First Posted: 2021-08-03
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid	Methylprednisolone Tablet	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	Methylprednisolone Tablet	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)

Primary Outcome Measures

Name	Time	Method
% of patients with radiological improvement	12 weeks	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.)
% of patients with functional improvement	12 weeks	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%
% of patients with clinical improvement	12 weeks	Clinical improvement is identified as grade 0 modified Medical Research Council (mMRC) dyspnea score with no respiratory complaints.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ufuk University Medicine Faculty; 🇹🇷 Ankara, Turkey