Comparison Between Different Doses of Steroids in COVID-19 Patients

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05279482
• Collaborator: (none)
• Enrollment: 104
• Locations: 2
• Actual Duration (Months): 1.6
• Patients Per Site: 52
• Patients Per Site Per Month: 32.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness; Pneumonia, Viral	Other: observation for outcome of methylprednisolone dose

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

• Study Type: Observational
• Actual Enrollment: 104 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Jan 19, 2022
• Actual Primary Completion Date: Mar 1, 2022
• Actual Study Completion Date: Mar 9, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 28 days mortality rate [1 month]

   observation for mortality rate in both groups

Secondary Outcome Measures

1. mechanical ventilation and icu length of stay [up to 3 months]

   observation for percentage of mechanically ventilated patients and length of stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain shams university hospitals	Cairo		Egypt
2	Faculty of medicine, Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr M Hilal Abdou, Assistant Professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05279482
• Other Study ID Numbers: MS41/2022
• First Posted: Mar 15, 2022
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia, Viral; Critical Illness; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

No Results Posted as of Mar 15, 2022