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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04499313
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 18, 2020
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
 (submitted: August 4, 2020)
  • 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
 (submitted: August 4, 2020)
  • 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
 (submitted: August 4, 2020)
60
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 No
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: No
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