Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow
Overview
- Phase
- Phase 4
- Intervention
- Dexamethasone
- Conditions
- COVID-19 Pandemic
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 28 days in hospital mortality
- Last Updated
- 4 years ago
Overview
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
Investigators
Eman Osama Zayed Mahmoud Rostom
teaching assistant
Cairo University
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
Arms & Interventions
Dexamethasone group
Patients will receive dexamethasone 8 mg q12hours
Intervention: Dexamethasone
methylprednisolone group
Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes
Intervention: Methylprednisolone
Outcomes
Primary Outcomes
28 days in hospital mortality
Time Frame: 28 days
all patients who will die in 28 days from the start of treatment
Secondary Outcomes
- WHO clinical progression scale(10 days)
- Adverse events related to steroids(10 days)
- Duration of ICU stay(10 days)
- Duration of high oxygen supplementation(10 days)