NCT04499313

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

August 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

July 27, 2020

Last Update Submit

August 17, 2020

Conditions

Covid19ARDS

Keywords

COVID 19DexamethasoneMethylprednisoloneARDS

Outcome Measures

Primary Outcomes (2)

  • Mortality rate (In hospital)

    Following randomization 30 days.

  • 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.

    Following randomization 30 days.

Secondary Outcomes (2)

  • Ventilator free days

    Following randomization 30 days.

  • Changes in Oxygen level

    Following randomization 30 days.

Study Arms (2)

Group A: Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Group B: Methylprednisolone

ACTIVE COMPARATOR

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

Drug: Methylprednisolone

Interventions

DexamethasoneDRUG

Injectable solution

Group A: Dexamethasone
MethylprednisoloneDRUG

Injectable solution

Group B: Methylprednisolone

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chattogram General Hospital

Chittagong, 4000, Bangladesh

RECRUITING

M. Abdur Rahim Medical College Hospital

Dinajpur, Bangladesh

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

DexamethasoneMethylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPrednisolone

Study Officials

  • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY DIRECTOR

  • Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

CONTACT

008801817711079dr_mohiuddinchy@yahoo.com

Shubhashis Talukder, MBBS, DO

CONTACT

008801911882232drshubhashis@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 5, 2020

Study Start

August 2, 2020

Primary Completion

November 15, 2020

Study Completion

November 30, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

BA(2)