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

Covid19 Clinical Trial

— STERCOV-ILD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988282
• Other study ID #: STERCOV-ILD
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: October 2023
• Source: Turkish Thoracic Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Covid19
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Methylprednisolone Tablet
Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks

Locations

Country	Name	City	State
Turkey	Ufuk University Medicine Faculty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Thoracic Society

Country where clinical trial is conducted

Turkey, 

Outcome

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