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RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow

Primary Purpose

COVID-19 Pandemic

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Dexamethasone

Methylprednisolone

About this trial

This is an interventional treatment trial for COVID-19 Pandemic focused on measuring steroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult (≥18 years of age) at time of enrolment
Present COVID-19 (infection confirmed by RT-PCR or antigen testing)
Postive pressure ventilation (non-invasive or invasive) or need supplemental oxygen with non-rebreather mask
Admission to ICU in the last 24 hours

Exclusion Criteria:

1- Underlying disease requiring chronic corticosteroids 2- Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrollment 3- Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock) 4-Any contraindication for corticosteroid administration 5-Cardiac arrest before ICU admission 6-Pregnancy or breast feeding 7- Immunocompromised patients as cancer (active) patients, patients on chemotherapy or radiotherapy, HIV, and transplant patients

Sites / Locations

Eman OsamaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dexamethasone group

methylprednisolone group

Arm Description

Patients will receive dexamethasone 8 mg q12hours

Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Outcomes

Primary Outcome Measures

28 days in hospital mortality

all patients who will die in 28 days from the start of treatment

Secondary Outcome Measures

WHO clinical progression scale

Adverse events related to steroids

incidence of infection or hyperglycemia

Duration of ICU stay

Duration of high oxygen supplementation

Full Information

NCT ID

NCT05062681

First Posted

September 24, 2021

Last Updated

September 28, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05062681

Brief Title

RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow

Official Title

Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

December 15, 2021 (Anticipated)

Study Completion Date

March 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to evaluate the therapeutic activity and side effects of 16 mg/day dexamethasone in comparison to equivalent dose of MP (1mg/kg/day)for the management of COVID-19 infected patients.Moreover, and according to the importance of the IL-6/STAT-3 in triggering the inflammatory cascade and as the miRNAs are considered as prognostic markers, hence, the study aims also to study the impact of the used regimens on these biomarkers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Pandemic

Keywords

steroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

RANDOMIZED CONT

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone group

Arm Type

Active Comparator

Arm Description

Patients will receive dexamethasone 8 mg q12hours

Arm Title

methylprednisolone group

Arm Type

Experimental

Arm Description

Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Patients will receive dexamethasone 8 mg q12hours

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Primary Outcome Measure Information:

Title

28 days in hospital mortality

Description

all patients who will die in 28 days from the start of treatment

Time Frame

28 days

Secondary Outcome Measure Information:

Title

WHO clinical progression scale

Description

WHO clinical progression scale

Time Frame

10 days

Title

Adverse events related to steroids

Description

incidence of infection or hyperglycemia

Time Frame

10 days

Title

Duration of ICU stay

Description

Duration of ICU stay

Time Frame

10 days

Title

Duration of high oxygen supplementation

Description

Duration of high oxygen supplementation

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult (≥18 years of age) at time of enrolment Present COVID-19 (infection confirmed by RT-PCR or antigen testing) Postive pressure ventilation (non-invasive or invasive) or need supplemental oxygen with non-rebreather mask Admission to ICU in the last 24 hours Exclusion Criteria: 1- Underlying disease requiring chronic corticosteroids 2- Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrollment 3- Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock) 4-Any contraindication for corticosteroid administration 5-Cardiac arrest before ICU admission 6-Pregnancy or breast feeding 7- Immunocompromised patients as cancer (active) patients, patients on chemotherapy or radiotherapy, HIV, and transplant patients

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eman Rostom, BSc

Phone

01111303366

eman.osama@std.pharma.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Dalaal Moustafa Abdallah, Professor

Phone

01222327743

dalaal.abdallah@pharma.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed EL-Ayashy, Ass. Professor

Organizational Affiliation

Ass. Professor of Anesthesia and Intensive Care

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamed Farouk Abdelsalam, Consultant

Organizational Affiliation

Consultant of Clinical Pharmacy and Clinical Nutrition Al-Galaa Military Medical Complex (GMMC)

Official's Role

Study Chair

Facility Information:

Facility Name

Eman Osama

City

Cairo

ZIP/Postal Code

11757

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eman Osama

Phone

01111303366

eman.osama@std.pharma.cu.edu.eg

12. IPD Sharing Statement

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RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow

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