High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19

NCT ID: NCT05047874

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-20

Study Completion Date

2021-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Short-term (3 Days) High-dose (1000 mg) Systemic Methylprednisolone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

systemic methylprednisolone

Intervention Type BEHAVIORAL

short-term (3 days) high-dose (1000 mg) systemic methylprednisolone and low-dose long-term (2x 40 mg) 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

systemic methylprednisolone

Intervention Type BEHAVIORAL

short-term (3 days) high-dose (1000 mg) systemic methylprednisolone and low-dose long-term (2x 40 mg) systemic methylprednisolone

Interventions

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systemic methylprednisolone

short-term (3 days) high-dose (1000 mg) systemic methylprednisolone and low-dose long-term (2x 40 mg) systemic methylprednisolone

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Patients with a diagnosis of steroid allergy or developing during treatment;
* pregnant or lactating women;
* Patients with active malignancy;
* Patients taking any immunosuppressive agent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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IKUPELI

investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ilke Kupeli

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ilke kupeli

Role: CONTACT

+905555485632

Facility Contacts

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ilke kupeli

Role: primary

05555485632

References

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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.

Reference Type BACKGROUND
PMID: 32192578 (View on PubMed)

Buttgereit 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.

Reference Type BACKGROUND
PMID: 15529366 (View on PubMed)

Rodriguez-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.

Reference Type RESULT
PMID: 33263084 (View on PubMed)

Edalatifard 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.

Reference Type RESULT
PMID: 32943404 (View on PubMed)

Li 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.

Reference Type RESULT
PMID: 33555845 (View on PubMed)

Other Identifiers

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BIRUNI 1

Identifier Type: -

Identifier Source: org_study_id

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