Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04847687 |
Other study ID # |
2011-KAEK-25 2021/03-02 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2021 |
Est. completion date |
April 1, 2021 |
Study information
Verified date |
April 2021 |
Source |
Bursa Yüksek Ihtisas Education and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.