Critical IllnessCOVID-19NCT05279482
Comparison Between Different Doses of Steroids in COVID-19 Patients
An observational study of Critical Illness and Pneumonia, Viral, run by Ain Shams University at 2 sites in Egypt.
Trial summary
aim of this study is to compare between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate, percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Pneumonia, Viral
- What is being tested?
- observation for outcome of methylprednisolone dose
- How many people
- 104 participants
- Where
- 2 sitesEgypt
- Study dates
- 19 Jan 2022to 9 Mar 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: SARS.COV.2. admitted in intensive care unit
Who may be able to join
- All icu admitted covid 19 patients with positive PCR, diagnosed by CT chest and needing oxygen therapy
Who cannot join
- Not requiring oxygen therapy
- Negative PCR
- Uncontrolled blood sugar or DKA
- Patients on long term steroids therapy
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain shams university hospitals
Cairo
Faculty of medicine, Ain Shams University
Cairo
About this study
Official title: Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study
aim of this study is to compare between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate, percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit.
Read the detailed description
Retrospective study for comparison between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate ,percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit.
Previous studies suggested that cytokine release syndrome could be involved in the pathophysiology of critical SARS.COV.2 resulting in death so early suppression of cytokine storm may be lifesaving in critical patients.
- Conditions
- Critical Illness, Pneumonia, Viral
- Being tested
- observation for outcome of methylprednisolone dose
- Medical subject headings
- Critical Illness, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation for outcome of methylprednisolone doseOther
no intervention as it is retrospective study for outcome
| Study group | Role | What they receive |
|---|---|---|
| group treated with standard dose methyl prednisolone | patients with positive PCR and requiring oxygen therapy Receives: Other: observation for outcome of methylprednisolone dose | |
| group treated with mega dose methyl prednisolone | patients with positive PCR and requiring oxygen therapy Receives: Other: observation for outcome of methylprednisolone dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days mortality rate
observation for mortality rate in both groups
Measured: 1 month
Secondary outcomes (1)
mechanical ventilation and icu length of stay
observation for percentage of mechanically ventilated patients and length of stay
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start19 Jan 2022
- Primary completion1 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr M Hilal Abdou, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279482
- Sponsor's protocol ID
- MS41/2022
- Acronym
- COVID-19
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study
- ClinicalTrials.gov ID
- NCT05279482
- Acronym / sponsor ID
- COVID-19 / MS41/2022
- Conditions
- Critical Illness, Pneumonia, Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 15 Mar 2022 (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 of this study is to compare between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate, percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit.
Detailed description
Retrospective study for comparison between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate ,percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit.
Previous studies suggested that cytokine release syndrome could be involved in the pathophysiology of critical SARS.COV.2 resulting in death so early suppression of cytokine storm may be lifesaving in critical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group treated with standard dose methyl prednisolone | – | Other: observation for outcome of methylprednisolone dosepatients with positive PCR and requiring oxygen therapy |
| group treated with mega dose methyl prednisolone | – | Other: observation for outcome of methylprednisolone dosepatients with positive PCR and requiring oxygen therapy |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- SARS.COV.2. admitted in intensive care unit
Key inclusion criteria (1 listed)
- All icu admitted covid 19 patients with positive PCR, diagnosed by CT chest and needing oxygen therapy
Key exclusion criteria (4 listed)
- Not requiring oxygen therapy
- Negative PCR
- Uncontrolled blood sugar or DKA
- Patients on long term steroids therapy
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 |
|---|---|---|
| observation for outcome of methylprednisolone doseno intervention as it is retrospective study for outcome | Other | group treated with mega dose methyl prednisolone, group treated with standard dose methyl prednisolone |
Primary outcome
28 days mortality rate
Time frame: 1 month
observation for mortality rate in both groups
1 secondary outcome
mechanical ventilation and icu length of stay
Time frame: up to 3 months
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 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Pneumonia, Viral, run by Ain Shams University at 2 sites in Egypt.
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 1 inclusion and 4 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 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
28 days mortality rate (time frame: 1 month). 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 15 Mar 2022.