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

Chattogram General Hospital

Status and phase: Unknown; Phase 3

Conditions: Covid19; ARDS

Treatments: Drug: Dexamethasone; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT04499313

10000753

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A: Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Group B: Methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: Methylprednisolone