Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19
Primary Purpose
Covid19, ARDS
Status
Unknown status
Phase
Phase 3
Locations
Bangladesh
Study Type
Interventional
Intervention
Dexamethasone
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID 19, Dexamethasone, Methylprednisolone, ARDS
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.
Sites / Locations
- Chattogram General HospitalRecruiting
- M. Abdur Rahim Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: Dexamethasone
Group B: Methylprednisolone
Arm Description
Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition.
Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)
Outcomes
Primary Outcome Measures
Mortality rate (In hospital)
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.
Secondary Outcome Measures
Ventilator free days
Changes in Oxygen level
Oxygen saturation in the peripheral blood determined by pulse oximetry.
Full Information
NCT ID
NCT04499313
First Posted
July 27, 2020
Last Updated
August 17, 2020
Sponsor
Chattogram General Hospital
Collaborators
Health Science Center of Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT04499313
Brief Title
Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19
Official Title
The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chattogram General Hospital
Collaborators
Health Science Center of Xi'an Jiaotong University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, ARDS
Keywords
COVID 19, Dexamethasone, Methylprednisolone, ARDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition.
Arm Title
Group B: Methylprednisolone
Arm Type
Active Comparator
Arm Description
Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Injectable solution
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Injectable solution
Primary Outcome Measure Information:
Title
Mortality rate (In hospital)
Time Frame
Following randomization 30 days.
Title
Clinical improvement
Description
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.
Time Frame
Following randomization 30 days.
Secondary Outcome Measure Information:
Title
Ventilator free days
Time Frame
Following randomization 30 days.
Title
Changes in Oxygen level
Description
Oxygen saturation in the peripheral blood determined by pulse oximetry.
Time Frame
Following randomization 30 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
Phone
008801817711079
Email
dr_mohiuddinchy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shubhashis Talukder, MBBS, DO
Phone
008801911882232
Email
drshubhashis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chattogram General Hospital
City
Chittagong
ZIP/Postal Code
4000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shubhashis Talukder
Phone
008801911882232
Email
drshubhashis@gmail.com
First Name & Middle Initial & Last Name & Degree
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
First Name & Middle Initial & Last Name & Degree
Shubhashis Talukder, MBBS, DO
Facility Name
M. Abdur Rahim Medical College Hospital
City
Dinajpur
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akter Kamal, MBBS, MD, PhD
Phone
008801817233991
Email
kamalaktar@yahoo.com
First Name & Middle Initial & Last Name & Degree
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
First Name & Middle Initial & Last Name & Degree
Akter Kamal, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19
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