Investigation of Hospitalisation Times and Mortality According to Drug Dose in Patients Given Systemic Methylprednisolone With a Pre-diagnosis of Covid-19 Pneumonia; Retrospective Study

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04847687
Collaborator
(none)
300
1
1
294.6

Study Details

Study Description

Brief Summary

Aim:There is still not enough data to determine methylprednisolone treatment timing, dosage, duration of use and indication in Covid 19 pneumonia. The aim of this study is to examine the relationship between drug dose and hospitalisation time and mortality rates in patients with pre-diagnosis of severe covid pneumonia and systemic methylprednisolone.

Materials and Methods: The demographic data, symptom durations, thorax CT findings, methylprednisolone dose and duration of treatment, hospitalisation times, intensive care hospitalizations of the patients who were initiated and hospitalized in the emergency department will be retrospectively recorded. Finally, the fate of the patients (such as discharge, referral, death) will be recorded.Statistical analysis will be conducted using the Statistical Package for Social Sciences (SPSS) (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) program.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Covid 19 infection can progress with widespread inflammation and cytokine storm. Induced excessive cytokine release is associated with tissue damage in the lung. Severe inflammatory / oxidative stress response and severe lung injury secondary to ARDS may develop. Therefore, suppressing the proinflammatory response has a very important place in treatment. Methylprednisolone is classically an immune response suppressor, powerful anti-inflammatory drug and is used in the treatment of covid 19 severe infection. However, there is still not enough data to determine the treatment timing, dosage, duration of use and indication.

The aim of this study is to examine the relationship between drug dose and hospitalisation time and mortality rates in patients with pre-diagnosis of severe covid pneumonia and systemic methylprednisolone.

Materials and Methods: The demographic data, symptom durations, thorax CT findings, methylprednisolone dose and duration of treatment, hospitalisation times, intensive care hospitalisations of the patients who were initiated and hospitalized in the emergency department will be retrospectively recorded. Finally, the fate of the patients (such as discharge, referral, death) will be recorded.

In the treatment of severe Covid 19 pneumonia, methylprednisolone treatment is used in addition to antiviral treatment. However, there are insufficient data on the time to start this treatment, drug dose and duration of use in daily routine. With the results of our study, we hope that we can contribute to the dose, duration and timing of methylprednisolone use in the treatment of Covid 19 pneumonia.

Study Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Group 1

Patients who are started on 1 mg/kg/day methylprednisolone. Demographic data of the patients, length of hospital stay, follow-up in intensive care unit and prognosis will be recorded.

Drug: methylprednisolone
Patients who are hospitalized with a pre-diagnosis of severe COVID-19 pneumonia and who are started on methylprednisolone will be divided into two groups according to the drug dose. Groups will be compared in terms of length of hospital stay, intensive care needs and prognosis.
Other Names:
  • COVID-19
  • Group 2

    Patients who are started on 250 mg/day methylprednisolone. Demographic data of the patients, length of hospital stay, follow-up in intensive care unit and prognosis will be recorded.

    Drug: methylprednisolone
    Patients who are hospitalized with a pre-diagnosis of severe COVID-19 pneumonia and who are started on methylprednisolone will be divided into two groups according to the drug dose. Groups will be compared in terms of length of hospital stay, intensive care needs and prognosis.
    Other Names:
  • COVID-19
  • Outcome Measures

    Primary Outcome Measures

    1. prognosis [died during hospitalisation]

      The patient was died.

    2. hospitalization time [days between hospitalisation and externalization or death]

      Time elapsed after the patient is hospitalized until person is discharged or died.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients older than 18 years of age who presented to our hospital's emergency clinic

    • Patients with pre-diagnosis of severe covid pneumonia

    • Patients starting methylprednisolone therapy.

    Exclusion Criteria:
    • <18 years

    • Patients with a pre-diagnosis of mild or moderate Covid 19 pneumonia

    • Patients not hospitalized in our hospital

    • Pregnant patients with Covid 19 pneumonia

    • Patients whose 5-methylprednisolone treatment was started in the emergency and discontinued in less than 3 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bursa Yüksek İhtisas EAH Bursa Eyalet/Yerleşke Turkey 16115

    Sponsors and Collaborators

    • Bursa Yüksek İhtisas Education and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seyhan Dülger,MD, Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital, Bursa Yüksek İhtisas Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04847687
    Other Study ID Numbers:
    • 2011-KAEK-25 2021/03-02
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Seyhan Dülger,MD, Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital, Bursa Yüksek İhtisas Education and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2021