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

Sponsor

Biruni University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05047874

Collaborator

(none)

200

Enrollment

Location

1.3

Anticipated Duration (Months)

152.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Short-term (3 Days) High-dose (1000 mg) Systemic Methylprednisolone	Behavioral: systemic methylprednisolone

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Anticipated Study Start Date :

Sep 20, 2021

Anticipated Primary Completion Date :

Oct 20, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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	Behavioral: systemic methylprednisolone 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	Behavioral: systemic methylprednisolone short-term (3 days) high-dose (1000 mg) systemic methylprednisolone and low-dose long-term (2x 40 mg) systemic methylprednisolone

Arm

Intervention/Treatment

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

Behavioral: systemic methylprednisolone

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

Behavioral: systemic methylprednisolone

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

Outcome Measures

Primary Outcome Measures

C Reaktif Protein [15 DAYS]
level of C Reaktif Protein

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)