Short-term (3 Days) High-dose (1000 mg) Systemic MethylprednisoloneNCT05047874
High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19
An observational study of Short-term (3 Days) High-dose (1000 mg) Systemic Methylprednisolone, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to compare, retrospectively, the 15-day continuous hemodynamic, laboratory and clinical course of COVID 19 patients to whom we administered short-term (3 days) high-dose (1000 mg) systemic methylprednisolone with those to whom low-dose long-term (2x 40 mg) systemic methylprednisolone was… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Short-term (3 Days) High-dose (1000 mg) Systemic Methylprednisolone
- What is being tested?
- systemic methylprednisolone
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2021to 30 Oct 2021
- Phase
- Observational
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: File records of patients over the age of 18 who were admitted to the General intensive care unit of Biruni University Medical Faculty Hospital between 1 June 2020 and 1 February 2021 with the diagnosis of COVID 19
Who may be able to join
- Between June 1, 2020 and February 1, 2021, hospitalized in the General intensive care unit of Biruni University Medical Faculty Hospital with the diagnosis of COVID 19;
- patients over 18 years of age; (for the diagnosis of COVID 19; Identification of SARS-CoV-2 by reverse transcription-polymerase chain reaction (RT-PCR) in nasopharyngeal swab or sputum samples and Abnormal lung computed tomography finding (CT) scan finding with <90% oxygen saturation at rest (bilateral, subpleural, peripheral ground glass opacities)
Who cannot join
- Patients with a diagnosis of steroid allergy or developing during treatment;
- pregnant or lactating women;
- Patients with active malignancy;
- Patients taking any immunosuppressive agent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ilke Kupeli
Istanbul, 24100
ilke kupeli, 05555485632, ilkeser2004@gmail.com
About this study
Official title: Comparison of High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19 - Retrospective Cross-sectional Study
In this study, we aimed to compare, retrospectively, the 15-day continuous hemodynamic, laboratory and clinical course of COVID 19 patients to whom we administered short-term (3 days) high-dose (1000 mg) systemic methylprednisolone with those to whom low-dose long-term (2x 40 mg) systemic methylprednisolone was administered.
- Being tested
- systemic methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic methylprednisoloneBehavioural
short-term (3 days) high-dose (1000 mg) systemic methylprednisolone and low-dose long-term (2x 40 mg) systemic methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| short-term (3 days) high-dose (1000 mg) systemic methylprednisolone | retrospectively, the 15-day continuous hemodynamic, laboratory and clinical course of COVID 19 patients to whom we administered short-term (3 days) high-dose (1000 mg) systemic methylprednisolone Receives: Behavioral: systemic methylprednisolone | |
| low-dose long-term (2x 40 mg) systemic methylprednisolone | retrospectively, the 15-day continuous hemodynamic, laboratory and clinical course of COVID 19 patients to whom low-dose long-term (2x 40 mg) systemic methylprednisolone Receives: Behavioral: systemic methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Reaktif Protein
level of C Reaktif Protein
Measured: 15 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion20 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Short-term (3 Days) High-dose (1000 mg) Systemic MethylprednisoloneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IKUPELI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047874
- Sponsor's protocol ID
- BIRUNI 1
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PubMed 32192578Buttgereit F, Straub RH, Wehling M, Burmester GR. Glucocorticoids in the treatment of rheumatic diseases: an update on the mechanisms of action. Arthritis Rheum. 2004 Nov;50(11):3408-17. doi: 10.1002/art.20583. No abstract available.
PubMed 15529366Rodriguez-Molinero A, Perez-Lopez C, Galvez-Barron C, Minarro A, Rodriguez Gullello EA, Collado Perez I, Mila Rafols N, Monaco EE, Hidalgo Garcia A, Ananos Carrasco G, Chamero Pastilla A; group of researchers for COVID-19 of the Consorci Sanitari de l'Alt Penedes i Garraf (CSAPG). Association between high-dose steroid therapy, respiratory function, and time to discharge in patients with COVID-19: Cohort study. Med Clin (Engl Ed). 2021 Jan 10;156(1):7-12. doi: 10.1016/j.medcle.2020.08.001. Epub 2020 Nov 27.
PubMed 33263084Edalatifard M, Akhtari M, Salehi M, Naderi Z, Jamshidi A, Mostafaei S, Najafizadeh SR, Farhadi E, Jalili N, Esfahani M, Rahimi B, Kazemzadeh H, Mahmoodi Aliabadi M, Ghazanfari T, Sattarian M, Ebrahimi Louyeh H, Raeeskarami SR, Jamalimoghadamsiahkali S, Khajavirad N, Mahmoudi M, Rostamian A. Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial. Eur Respir J. 2020 Dec 24;56(6):2002808. doi: 10.1183/13993003.02808-2020. Print 2020 Dec.
PubMed 32943404Li J, Liao X, Zhou Y, Wang L, Yang H, Zhang W, Zhang Z, Kang Y. Comparison of Associations Between Glucocorticoids Treatment and Mortality in COVID-19 Patients and SARS Patients: A Systematic Review and Meta-Analysis. Shock. 2021 Aug 1;56(2):215-228. doi: 10.1097/SHK.0000000000001738.
PubMed 33555845
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19 - Retrospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05047874
- Acronym / sponsor ID
- BIRUNI 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 20 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 17 Sep 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.
In this study, we aimed to compare, retrospectively, the 15-day continuous hemodynamic, laboratory and clinical course of COVID 19 patients to whom we administered short-term (3 days) high-dose (1000 mg) systemic methylprednisolone with those to whom low-dose long-term (2x 40 mg) systemic methylprednisolone was administered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-term (3 days) high-dose (1000 mg) systemic methylprednisolone | – | Behavioral: systemic methylprednisoloneretrospectively, the 15-day continuous hemodynamic, laboratory and clinical course of COVID 19 patients to whom we administered short-term (3 days) high-dose (1000 mg) systemic methylprednisolone |
| low-dose long-term (2x 40 mg) systemic methylprednisolone | – | Behavioral: systemic methylprednisoloneretrospectively, the 15-day continuous hemodynamic, laboratory and clinical course of COVID 19 patients to whom low-dose long-term (2x 40 mg) systemic methylprednisolone |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- File records of patients over the age of 18 who were admitted to the General intensive care unit of Biruni University Medical Faculty Hospital between 1 June 2020 and 1 February 2021 with the diagnosis of COVID 19
Key inclusion criteria (2 listed)
- Between June 1, 2020 and February 1, 2021, hospitalized in the General intensive care unit of Biruni University Medical Faculty Hospital with the diagnosis of COVID 19;
- patients over 18 years of age; (for the diagnosis of COVID 19; Identification of SARS-CoV-2 by reverse transcription-polymerase chain reaction (RT-PCR) in nasopharyngeal swab or sputum samples and Abnormal lung computed tomography finding (CT) scan finding with <90% oxygen saturation at rest (bilateral, subpleural, peripheral ground glass opacities)
Key exclusion criteria (4 listed)
- Patients with a diagnosis of steroid allergy or developing during treatment;
- pregnant or lactating women;
- Patients with active malignancy;
- Patients taking any immunosuppressive agent.
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 |
|---|---|---|
| systemic methylprednisoloneshort-term (3 days) high-dose (1000 mg) systemic methylprednisolone and low-dose long-term (2x 40 mg) systemic methylprednisolone | Behavioural | low-dose long-term (2x 40 mg) systemic methylprednisolone, short-term (3 days) high-dose (1000 mg) systemic methylprednisolone |
Primary outcome
C Reaktif Protein
Time frame: 15 DAYS
level of C Reaktif Protein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 32192578Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
- Background: PubMed 15529366Buttgereit F, Straub RH, Wehling M, Burmester GR. Glucocorticoids in the treatment of rheumatic diseases: an update on the mechanisms of action. Arthritis Rheum. 2004 Nov;50(11):3408-17. doi: 10.1002/art.20583. No abstract available.
- Results publication: PubMed 33263084Rodriguez-Molinero A, Perez-Lopez C, Galvez-Barron C, Minarro A, Rodriguez Gullello EA, Collado Perez I, Mila Rafols N, Monaco EE, Hidalgo Garcia A, Ananos Carrasco G, Chamero Pastilla A; group of researchers for COVID-19 of the Consorci Sanitari de l'Alt Penedes i Garraf (CSAPG). Association between high-dose steroid therapy, respiratory function, and time to discharge in patients with COVID-19: Cohort study. Med Clin (Engl Ed). 2021 Jan 10;156(1):7-12. doi: 10.1016/j.medcle.2020.08.001. Epub 2020 Nov 27.
- Results publication: PubMed 32943404Edalatifard M, Akhtari M, Salehi M, Naderi Z, Jamshidi A, Mostafaei S, Najafizadeh SR, Farhadi E, Jalili N, Esfahani M, Rahimi B, Kazemzadeh H, Mahmoodi Aliabadi M, Ghazanfari T, Sattarian M, Ebrahimi Louyeh H, Raeeskarami SR, Jamalimoghadamsiahkali S, Khajavirad N, Mahmoudi M, Rostamian A. Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial. Eur Respir J. 2020 Dec 24;56(6):2002808. doi: 10.1183/13993003.02808-2020. Print 2020 Dec.
- Results publication: PubMed 33555845Li J, Liao X, Zhou Y, Wang L, Yang H, Zhang W, Zhang Z, Kang Y. Comparison of Associations Between Glucocorticoids Treatment and Mortality in COVID-19 Patients and SARS Patients: A Systematic Review and Meta-Analysis. Shock. 2021 Aug 1;56(2):215-228. doi: 10.1097/SHK.0000000000001738.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short-term (3 Days) High-dose (1000 mg) Systemic Methylprednisolone, run by Biruni University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke kupeli (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C Reaktif Protein (time frame: 15 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047874, which also lists 5 linked publications.
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 17 Sep 2021.