NCT05279482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

March 10, 2022

Last Update Submit

March 12, 2022

Conditions

Critical IllnessPneumonia, Viral

Outcome Measures

Primary Outcomes (1)

  • 28 days mortality rate

    observation for mortality rate in both groups

    1 month

Secondary Outcomes (1)

  • mechanical ventilation and icu length of stay

    up to 3 months

Study Arms (2)

group treated with standard dose methyl prednisolone

patients with positive PCR and requiring oxygen therapy

Other: observation for outcome of methylprednisolone dose

group treated with mega dose methyl prednisolone

patients with positive PCR and requiring oxygen therapy

Other: observation for outcome of methylprednisolone dose

Interventions

observation for outcome of methylprednisolone doseOTHER

no intervention as it is retrospective study for outcome

group treated with mega dose methyl prednisolonegroup treated with standard dose methyl prednisolone

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

SARS.COV.2. admitted in intensive care unit

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain shams university hospitals

Cairo, Egypt

Location

Faculty of medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Critical IllnessPneumonia, Viral

Interventions

Observation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 15, 2022

Study Start

January 19, 2022

Primary Completion

March 1, 2022

Study Completion

March 9, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

EG(2)