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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

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.

Condition or disease Intervention/treatment Phase
Covid19 ARDS Drug: Dexamethasone Drug: Methylprednisolone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19
Actual Study Start Date : August 2, 2020
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : November 30, 2020


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




Primary Outcome Measures :
  1. Mortality rate (In hospital) [ Time Frame: Following randomization 30 days. ]
  2. 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 Outcome Measures :
  1. Ventilator free days [ Time Frame: Following randomization 30 days. ]
  2. Changes in Oxygen level [ Time Frame: Following randomization 30 days. ]
    Oxygen saturation in the peripheral blood determined by pulse oximetry.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499313


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

Locations
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Bangladesh
Chattogram General Hospital Recruiting
Chittagong, Bangladesh, 4000
Contact: Shubhashis Talukder    008801911882232    drshubhashis@gmail.com   
Principal Investigator: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD         
Sub-Investigator: Shubhashis Talukder, MBBS, DO         
M. Abdur Rahim Medical College Hospital Recruiting
Dinajpur, Bangladesh
Contact: Akter Kamal, MBBS, MD, PhD    008801817233991    kamalaktar@yahoo.com   
Principal Investigator: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD         
Sub-Investigator: Akter Kamal, MD, PhD         
Sponsors and Collaborators
Chattogram General Hospital
Health Science Center of Xi'an Jiaotong University
Investigators
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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
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Responsible Party: Chattogram General Hospital
ClinicalTrials.gov Identifier: NCT04499313    
Other Study ID Numbers: 10000753
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Chattogram General Hospital:
COVID 19
Dexamethasone
Methylprednisolone
ARDS
Additional relevant MeSH terms:
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Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents