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

Study Overview
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Brief Summary
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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

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

Conditions
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COVID-19 Pandemic

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMIZED CONT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone group<br>Patients will receive dexamethasone 8 mg q12hours | Drug: Dexamethasone<br>* Patients will receive dexamethasone 8 mg q12hours<br>|
| Experimental: methylprednisolone group<br>Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes | Drug: Methylprednisolone<br>* Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days in hospital mortality | all patients who will die in 28 days from the start of treatment | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO clinical progression scale | WHO clinical progression scale | 10 days | 
| Adverse events related to steroids | incidence of infection or hyperglycemia | 10 days | 
| Duration of ICU stay | Duration of ICU stay | 10 days | 
| Duration of high oxygen supplementation | Duration of high oxygen supplementation | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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steroids