Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease (STERCOV-ILD)

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Interstitial Lung Disease; COVID-19 Pneumonia
• Intervention / Treatment: Drug: Methylprednisolone Tablet

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06520
    • Ufuk University Medicine Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	Drug: Methylprednisolone Tablet; Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks; Other Names: Prednol
Active Comparator: 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	Drug: Methylprednisolone Tablet; Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks; Other Names: Prednol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Turkish Thoracic Society
• Investigators: Study Director: METİN AKGÜN, Atatürk University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; COVID-19; Lung Diseases; Lung Diseases, Interstitial; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: STERCOV-ILD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No