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

Overview

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.

Full Title of Study: “The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 15, 2020

Interventions

  • Drug: Dexamethasone
    • Injectable solution
  • Drug: Methylprednisolone
    • Injectable solution

Arms, Groups and Cohorts

  • Active Comparator: Group A: Dexamethasone
    • Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient’s condition.
  • Active Comparator: Group B: Methylprednisolone
    • Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)

Clinical Trial Outcome Measures

Primary Measures

  • Mortality rate (In hospital)
    • Time Frame: Following randomization 30 days.
  • Clinical improvement
    • Time Frame: Following randomization 30 days.
    • 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.

Secondary Measures

  • Ventilator free days
    • Time Frame: Following randomization 30 days.
  • Changes in Oxygen level
    • Time Frame: Following randomization 30 days.
    • Oxygen saturation in the peripheral blood determined by pulse oximetry.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chattogram General Hospital
  • Collaborator
    • Health Science Center of Xi’an Jiaotong University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, Study Director, First Affiliated Hospital Xi’an Jiaotong University
    • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, Principal Investigator, First Affiliated Hospital Xi’an Jiaotong University
  • Overall Contact(s)
    • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, 008801817711079, dr_mohiuddinchy@yahoo.com

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