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

NCT ID: NCT04988282

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2022-01-31

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.

Conditions

Covid19; COVID-19 Pneumonia; Interstitial Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Steroid

Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks; followed by a gradual reduction of 25% every 2 weeks.

Total Duration:12-16 weeks

Group Type: ACTIVE_COMPARATOR

Methylprednisolone Tablet

Intervention Type: DRUG

Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks

control

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)

Group Type: OTHER

Methylprednisolone Tablet

Intervention Type: DRUG

Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks

Interventions

Methylprednisolone Tablet

Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks

Intervention Type: DRUG

Other Intervention Names

Prednol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkish Thoracic Society

OTHER

Sponsor Role: lead

Responsible Party

Metin Akgun

MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

METİN AKGÜN

Role: STUDY_DIRECTOR

ATATURK UNIVERSITY FACULTY OF MEDICINE

Locations

Ufuk University Medicine Faculty

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

STERCOV-ILD

Identifier Type: -

Identifier Source: org_study_id