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

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ClinicalTrials.gov Identifier: NCT04499313

Recruitment Status : Recruiting

First Posted : August 5, 2020

Last Update Posted : August 18, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Health Science Center of Xi'an Jiaotong University

Information provided by (Responsible Party):

Chattogram General Hospital

Tracking Information

First Submitted Date ^ICMJE

July 27, 2020

First Posted Date ^ICMJE

August 5, 2020

Last Update Posted Date

August 18, 2020

Actual Study Start Date ^ICMJE

August 2, 2020

Estimated Primary Completion Date

November 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Covid19
ARDS

Intervention ^ICMJE

Drug: Dexamethasone
Injectable solution
Drug: Methylprednisolone
Injectable solution

Study Arms ^ICMJE

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.

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

Intervention: Drug: Methylprednisolone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

November 30, 2020

Estimated Primary Completion Date

November 15, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

20 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD	008801817711079	dr_mohiuddinchy@yahoo.com
Contact: Shubhashis Talukder, MBBS, DO	008801911882232	drshubhashis@gmail.com

Listed Location Countries ^ICMJE

Bangladesh

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04499313

Other Study ID Numbers ^ICMJE

10000753

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Responsible Party

Chattogram General Hospital

Study Sponsor ^ICMJE

Chattogram General Hospital

Collaborators ^ICMJE

Health Science Center of Xi'an Jiaotong University

Investigators ^ICMJE

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

PRS Account

Chattogram General Hospital

Verification Date

August 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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