Covid19Phase 4STERCOV-ILDNCT04988282
Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease
A Phase 4 study testing Methylprednisolone Tablet in people with Covid19 and COVID-19 Pneumonia, run by Turkish Thoracic Society at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, COVID-19 Pneumonia, Interstitial Lung Disease
- What is being tested?
- Methylprednisolone Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2021to 31 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Younger than 18 years old
- Pregnant women
- Breastfeeding women
- Those who do not give written consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ufuk University Medicine Faculty
Ankara, 06520
About this study
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
- Being tested
- Methylprednisolone Tablet
- Medical subject headings
- COVID-19, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone TabletDrug
Also called Prednol
Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Methylprednisolone Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with clinical improvement
Clinical improvement is identified as grade 0 modified Medical Research Council (mMRC) dyspnea score with no respiratory complaints.
Measured: 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%
Measured: 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.)
Measured: 12 weeks
Secondary outcomes (8)
Improvement of diffusion capacity of lung for carbon monoxide (DLCO)
Percentage of increase in diffusion capacity of lung for carbon monoxide
Measured: 12 weeks
Improvement of Forced Vital Capacity (FVC)
Change in Forced Vital Capacity
Measured: 12 weeks
Improvement of arterial oxygen saturation (SaO2)
Change in Oxygen Saturation at room air
Measured: 12 weeks
Improvement of Exercise Capacity
Change in 6 minute walking test duration
Measured: 12 weeks
Improvement of mMRC dyspnea score
Change in mMRC dyspnea score
Measured: 12 weeks
Respiratory-cause emergency visit and hospitalisation
Number of patients who had respiratory-cause emergency visit and hospitalization during study period.
Measured: 12 weeks
Mortality rate
Mortality rate
Measured: 12 weeks
Advers events
Systemic corticosteroid related advers events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start24 May 2021
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Thoracic Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metin Akgun, Turkish Thoracic Society
- Investigators
- METİN AKGÜN, Study director, ATATURK UNIVERSITY FACULTY OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988282
- Sponsor's protocol ID
- STERCOV-ILD
- Acronym
- STERCOV-ILD
- Status last verified
- Oct 2023
- First submitted
- 22 Jul 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04988282
- Acronym / sponsor ID
- STERCOV-ILD / STERCOV-ILD
- Conditions
- Covid19, COVID-19 Pneumonia, Interstitial Lung Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Turkish Thoracic SocietyUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid | Active comparator | Drug: Methylprednisolone TabletMethylprednisolone, oral, 0.5 mg/kg/day, 4 weeks; followed by a gradual reduction of 25% every 2 weeks. Total Duration:12-16 weeks |
| control | Other | Drug: Methylprednisolone Tabletstandard 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone TabletAlso: PrednolMethylprednisolone, oral, 0.5 mg/kg/day, 4 weeks | Drug | Steroid, control |
Primary outcome
% 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.
% 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%
% 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.)
8 secondary outcomes
Improvement of diffusion capacity of lung for carbon monoxide (DLCO)
Time frame: 12 weeks
Improvement of Forced Vital Capacity (FVC)
Time frame: 12 weeks
Improvement of arterial oxygen saturation (SaO2)
Time frame: 12 weeks
Improvement of Exercise Capacity
Time frame: 12 weeks
Improvement of mMRC dyspnea score
Time frame: 12 weeks
Respiratory-cause emergency visit and hospitalisation
Time frame: 12 weeks
Mortality rate
Time frame: 12 weeks
Advers events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
METİN AKGÜN study director
ATATURK UNIVERSITY FACULTY OF MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone Tablet in people with Covid19 and COVID-19 Pneumonia, run by Turkish Thoracic Society at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with clinical improvement (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.