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

NCT ID: NCT04499313

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-02

Study Completion Date

2020-11-30

Brief Summary

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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

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Conditions

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Covid19 ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Dexamethasone

Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Injectable solution

Group B: Methylprednisolone

Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

Injectable solution

Interventions

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Dexamethasone

Injectable solution

Intervention Type DRUG

Methylprednisolone

Injectable solution

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Chattogram General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Role: STUDY_DIRECTOR

First Affiliated Hospital Xi'an Jiaotong University

Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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Chattogram General Hospital

Chittagong, , Bangladesh

Site Status RECRUITING

M. Abdur Rahim Medical College Hospital

Dinajpur, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Role: CONTACT

008801817711079

Shubhashis Talukder, MBBS, DO

Role: CONTACT

008801911882232

Facility Contacts

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Shubhashis Talukder

Role: primary

008801911882232

Akter Kamal, MBBS, MD, PhD

Role: primary

008801817233991

Other Identifiers

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10000753

Identifier Type: -

Identifier Source: org_study_id

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