Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19

Study Overview
=================
Brief Summary
-----------------
A randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.

Official Title
-----------------
The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19

Conditions
-----------------
Covid19, ARDS

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case. Exclusion Criteria: Participants with uncontrolled clinical status who were hospitalized from the before. Contraindication / possible drug interaction. Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, pregnancy, Corpulmonale, etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Dexamethasone<br>Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition. | Drug: Dexamethasone<br>* Injectable solution<br>|
| Active Comparator: Group B: Methylprednisolone<br>Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution) | Drug: Methylprednisolone<br>* Injectable solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate (In hospital) |  | Following randomization 30 days. | 
| Clinical improvement | The number of participants with Clinical improvement determined by the improvement of individual presenting symptoms of the COVID19; changes in radiological and laboratory values.Patient admitted in general bed requiring High Dependency Unit (HDU), and an HDU patient requiring Ventilator or Intensive care support. | Following randomization 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days |  | Following randomization 30 days. | 
| Changes in Oxygen level | Oxygen saturation in the peripheral blood determined by pulse oximetry. | Following randomization 30 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID 19, Dexamethasone, Methylprednisolone, ARDS