COVID-19NCT04847687
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
An observational study of COVID-19 and Methylprednisolone, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Methylprednisolone, Pneumonia
- What is being tested?
- methylprednisolone
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas EAH
Bursa, Eyalet/Yerleşke, 16115
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Methylprednisolone, Pneumonia
- Being tested
- methylprednisolone
- Keywords
- COVID-19, Methylprednisolone, Pneumonia
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called COVID-19
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis
The patient was died.
Measured: died during hospitalisation
hospitalization time
Time elapsed after the patient is hospitalized until person is discharged or died.
Measured: days between hospitalisation and externalization or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Mar 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seyhan Dülger,MD, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847687
- Sponsor's protocol ID
- 2011-KAEK-25 2021/03-02
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic data of patients, duration of haspitalization, need for intensive care and prognosis will be shared with all researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital
- ClinicalTrials.gov ID
- NCT04847687
- Acronym / sponsor ID
- 2011-KAEK-25 2021/03-02
- Conditions
- COVID-19, Methylprednisolone, Pneumonia
- Keywords
- COVID-19, Methylprednisolone, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: methylprednisolonePatients 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. |
| Group 2 | – | Drug: methylprednisolonePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisoloneAlso: COVID-19Patients 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. | Drug | Group 1, Group 2 |
Primary outcome
prognosis
Time frame: died during hospitalisation
The patient was died.
hospitalization time
Time frame: days between hospitalisation and externalization or death
Time elapsed after the patient is hospitalized until person is discharged or died.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Yes. Demographic data of patients, duration of haspitalization, need for intensive care and prognosis will be shared with all researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Methylprednisolone, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis (time frame: died during hospitalisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.