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OpenTrials
Completed

NCT Number: NCT04988282

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ufuk University Medicine Faculty

Ankara, 06520, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone Tablet

Drug

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

Other names: Prednol

Primary outcomes

  1. % of patients with clinical improvement

    Time frame: 12 weeks

    Clinical improvement is identified as grade 0 modified Medical Research Council (mMRC) dyspnea score with no respiratory complaints.

  2. % of patients with functional improvement

    Time frame: 12 weeks

    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%

  3. % of patients with radiological improvement

    Time frame: 12 weeks

    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.)

Secondary outcomes

  1. Improvement of diffusion capacity of lung for carbon monoxide (DLCO)

    Time frame: 12 weeks

    Percentage of increase in diffusion capacity of lung for carbon monoxide

  2. Improvement of Forced Vital Capacity (FVC)

    Time frame: 12 weeks

    Change in Forced Vital Capacity

  3. Improvement of arterial oxygen saturation (SaO2)

    Time frame: 12 weeks

    Change in Oxygen Saturation at room air

  4. Improvement of Exercise Capacity

    Time frame: 12 weeks

    Change in 6 minute walking test duration

  5. Improvement of mMRC dyspnea score

    Time frame: 12 weeks

    Change in mMRC dyspnea score

  6. Respiratory-cause emergency visit and hospitalisation

    Time frame: 12 weeks

    Number of patients who had respiratory-cause emergency visit and hospitalization during study period.

  7. Mortality rate

    Time frame: 12 weeks

    Mortality rate

  8. Advers events

    Time frame: 12 weeks

    Systemic corticosteroid related advers events

Sponsors and collaborators

Lead sponsor

Turkish Thoracic Society

Other

Registry information

Acronym: STERCOV-ILD

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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