Comparison Between Different Doses of Steroids in COVID-19 Patients (COVID-19)

March 12, 2022 updated by: Amr M Hilal Abdou, Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Medicine, Ain Shams University
      • Cairo, Egypt
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SARS.COV.2. admitted in intensive care unit

Description

Inclusion Criteria:

  • All icu admitted covid 19 patients with positive PCR, diagnosed by CT chest and needing oxygen therapy

Exclusion Criteria:

  • Not requiring oxygen therapy
  • Negative PCR
  • Uncontrolled blood sugar or DKA
  • Patients on long term steroids therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group treated with standard dose methyl prednisolone
patients with positive PCR and requiring oxygen therapy
Other: observation for outcome of methylprednisolone dose
no intervention as it is retrospective study for outcome
group treated with mega dose methyl prednisolone
patients with positive PCR and requiring oxygen therapy
Other: observation for outcome of methylprednisolone dose
no intervention as it is retrospective study for outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 days mortality rate
Time Frame: 1 month
observation for mortality rate in both groups
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mechanical ventilation and icu length of stay
Time Frame: up to 3 months
observation for percentage of mechanically ventilated patients and length of stay
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS41/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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