Clinical trial NCT04847687: 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
Official title: Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Methylprednisolone
Pneumonia
Keywords: COVID-19
Methylprednisolone
Pneumonia
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years of age who presented to our hospital's emergency clinic with a pre-diagnosis of severe covid pneumonia and who were started on methylprednisolone treatment

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: prognosis
timeFrame: died during hospitalisation
measure: hospitalization time
timeFrame: days between hospitalisation and externalization or death
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas EAH
state: Eyalet/Yerleşke
Study officials:
References: