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

September 16, 2021 updated by: IKUPELI, Biruni University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 24100
        • Recruiting
        • Ilke Kupeli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C Reaktif Protein
Time Frame: 15 DAYS
level of C Reaktif Protein
15 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 20, 2021

Primary Completion (Anticipated)

October 20, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIRUNI 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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