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

NCT04847687 | Completed FDA Drug

• 1 other identifier: 2011-KAEK-25 2021/03-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Methylprednisolone; Pneumonia

Keywords

COVID-19; Methylprednisolone; Pneumonia

Outcome Measures

Primary Outcomes (2)

• prognosis

  The patient was died.

  died during hospitalisation

• hospitalization time

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

  days between hospitalisation and externalization or death

Study Arms (2)

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

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

Interventions

methylprednisolone DRUG

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.

Also known as: COVID-19

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yüksek İhtisas EAH

Bursa, Eyalet/Yerleşke, 16115, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: March 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be used for 3 months after April 1, 2021.

Locations

TU (1)