Clinical trial NCT05047874: High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Short-term (3 Days) High-dose (1000 mg) Systemic Methylprednisolone
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 administered.


Eligibility criteria: 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.

Primary outcomes:
measure: C Reaktif Protein
timeFrame: 15 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ilke Kupeli
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.