Clinical trial NCT04988282: Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease
Official title: Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
COVID-19 Pneumonia
Interstitial Lung Disease
Lead sponsor: Turkish Thoracic Society
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: % of patients with clinical improvement
timeFrame: 12 weeks
measure: % of patients with functional improvement
timeFrame: 12 weeks
measure: % of patients with radiological improvement
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement of diffusion capacity of lung for carbon monoxide (DLCO)
timeFrame: 12 weeks
measure: Improvement of Forced Vital Capacity (FVC)
timeFrame: 12 weeks
measure: Improvement of arterial oxygen saturation (SaO2)
timeFrame: 12 weeks
measure: Improvement of Exercise Capacity
timeFrame: 12 weeks
measure: Improvement of mMRC dyspnea score
timeFrame: 12 weeks
measure: Respiratory-cause emergency visit and hospitalisation
timeFrame: 12 weeks
measure: Mortality rate
timeFrame: 12 weeks
measure: Advers events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Medicine Faculty
Study officials:
affiliation: ATATURK UNIVERSITY FACULTY OF MEDICINE
name: METİN AKGÜN
role: STUDY_DIRECTOR
References: