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

Phase 3

• Conditions: Covid19; ARDS
• Interventions: Drug: Dexamethasone; Drug: Methylprednisolone

• Registration Number: NCT04499313
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-27
• Status Verified: 2020-08
• Study Start: 2020-08-02
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-18
• Primary Completion: 2020-11-15
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Dexamethasone	Dexamethasone	Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition.
Group B: Methylprednisolone	Methylprednisolone	Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)

Primary Outcome Measures

Name	Time	Method
Mortality rate (In hospital)	Following randomization 30 days.
Clinical improvement	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

Name	Time	Method
Changes in Oxygen level	Following randomization 30 days.	Oxygen saturation in the peripheral blood determined by pulse oximetry.
Ventilator free days	Following randomization 30 days.

Trial Locations

Locations (2)

Chattogram General Hospital; 🇧🇩 Chittagong, Bangladesh

M. Abdur Rahim Medical College Hospital; 🇧🇩 Dinajpur, Bangladesh