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

August 17, 2020 updated by: Chattogram General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bangladesh
      • Chittagong, Bangladesh, 4000
        • Recruiting
        • Chattogram General Hospital
        • Contact:
        • Principal Investigator:
          • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
        • Sub-Investigator:
          • Shubhashis Talukder, MBBS, DO
      • Dinajpur, Bangladesh
        • Recruiting
        • M. Abdur Rahim Medical College Hospital
        • Principal Investigator:
          • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
        • Contact:
        • Sub-Investigator:
          • Akter Kamal, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Dexamethasone
Injectable solution
Active Comparator: Group B: Methylprednisolone
Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)
Drug: Methylprednisolone
Injectable solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate (In hospital)
Time Frame: Following randomization 30 days.
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.
Following randomization 30 days.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chattogram General Hospital

Collaborators

Health Science Center of Xi'an Jiaotong University

Investigators

  • Study Director: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, First Affiliated Hospital Xi'an Jiaotong University
  • Principal Investigator: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2020

Primary Completion (Anticipated)

November 15, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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