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

Covid19 Clinical Trial

Official title:

The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499313
• Other study ID #: 10000753
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2020
• Source: Chattogram General Hospital
• Contact: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
• Phone: 008801817711079
• Email: dr_mohiuddinchy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• Covid19

Intervention

Drug:
• Dexamethasone
Injectable solution
• Methylprednisolone
Injectable solution

Locations

Country	Name	City	State
Bangladesh	Chattogram General Hospital	Chittagong
Bangladesh	M. Abdur Rahim Medical College Hospital	Dinajpur

Sponsors (2)

Lead Sponsor	Collaborator
Chattogram General Hospital	Health Science Center of Xi'an Jiaotong University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate (In hospital)		Following randomization 30 days.
Primary	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	Ventilator free days		Following randomization 30 days.
Secondary	Changes in Oxygen level	Oxygen saturation in the peripheral blood determined by pulse oximetry.	Following randomization 30 days.