- ICH GCP
- US Clinical Trials Registry
- 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
Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Eyalet/Yerleşke
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Bursa, Eyalet/Yerleşke, Turkey, 16115
- Bursa yüksek ihtisas EAH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
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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:
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prognosis
Time Frame: died during hospitalisation
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The patient was died.
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died during hospitalisation
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hospitalization time
Time Frame: days between hospitalisation and externalization or death
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Time elapsed after the patient is hospitalized until person is discharged or died.
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days between hospitalisation and externalization or death
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Lung Diseases
- COVID-19
- Pneumonia
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- 2011-KAEK-25 2021/03-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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