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

NCT04988282 | Completed Phase 4

• 1 other identifier: STERCOV-ILD
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• % 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 Outcomes (8)

• Improvement of diffusion capacity of lung for carbon monoxide (DLCO)

  12 weeks

• Improvement of Forced Vital Capacity (FVC)

  12 weeks

• Improvement of arterial oxygen saturation (SaO2)

  12 weeks

• Improvement of Exercise Capacity

  12 weeks

• Improvement of mMRC dyspnea score

  12 weeks

Study Arms (2)

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

Drug: Methylprednisolone Tablet

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)

Drug: Methylprednisolone Tablet

Interventions

Methylprednisolone Tablet DRUG

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

Also known as: Prednol

Steroid; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Turkish Thoracic Society: lead

Study Sites (1)

Ufuk University Medicine Faculty

Ankara, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Lung Diseases, Interstitial

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• METİN AKGÜN

  ATATURK UNIVERSITY FACULTY OF MEDICINE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 3, 2021
• Study Start: May 24, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)