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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05062681

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pandemic	Drug: Dexamethasone Drug: Methylprednisolone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RANDOMIZED CONTRANDOMIZED CONT

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2021

Anticipated Primary Completion Date :

Dec 15, 2021

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexamethasone group Patients will receive dexamethasone 8 mg q12hours	Drug: Dexamethasone Patients will receive dexamethasone 8 mg q12hours
Experimental: methylprednisolone group Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes	Drug: Methylprednisolone Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes

Arm

Intervention/Treatment

Active Comparator: Dexamethasone group

Patients will receive dexamethasone 8 mg q12hours

Drug: Dexamethasone

Patients will receive dexamethasone 8 mg q12hours

Experimental: methylprednisolone group

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

Drug: Methylprednisolone

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

Outcome Measures

Primary Outcome Measures

28 days in hospital mortality [28 days]
all patients who will die in 28 days from the start of treatment

Secondary Outcome Measures

WHO clinical progression scale [10 days]
WHO clinical progression scale
Adverse events related to steroids [10 days]
incidence of infection or hyperglycemia
Duration of ICU stay [10 days]
Duration of ICU stay
Duration of high oxygen supplementation [10 days]
Duration of high oxygen supplementation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eman Osama	Cairo		Egypt	11757

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Mohamed EL-Ayashy, Ass. Professor, Ass. Professor of Anesthesia and Intensive Care
Study Chair: Mohamed Farouk Abdelsalam, Consultant, Consultant of Clinical Pharmacy and Clinical Nutrition Al-Galaa Military Medical Complex (GMMC)