A comparative study of the effectiveness between pulse regimen methylprednisolone versus high dose dexamethasone as the initial treatment of moderate Covid-19 pneumonia: An open-label randomized controlled trial

Phase 3

• Conditions: Moderate Covid-19 pneumonia; Moderate Covid 19, Moderate pneumonia, Covid 19 pneumonia, Methylprednisolone, Dexamethasone

• Registration Number: TCTR20211017001
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-17
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age over 18 years old
2. Visited within 48 hours
3. Respiratory sample was confirmed Covid-19 by RT-PCR
4. Evidence of pneumonia by chest imaging
5. Resting oxygen saturation between 90-94%
6. Voluntary consent

Exclusion Criteria

1. Recieved high flow nasal cannula, non-invasive mechanical ventilation or invasive mechanical ventilation
2. High risk for cortiosteroid such as current active infection or poor glycemic control
3. Immunocompromised host such as end stage liver disease, end stage renal disease without renal replacement therapy, HIV CD4 less than 200 or cancer with on going chemotherapy
4. Pregnant women
5. Psychiatric problems
6. Current use of corticosteroid (more than 20 mg of prednisolone equivalent dose and consecutively more than 14 day)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean of WHO clinical progression scale at day 5 day 5 WHO clinical progression scale

Secondary Outcome Measures

Name	Time	Method
Mean of WHO clinical progression scale at day 10 Day 10 WHO clinical progression scale,Improvement of oxygenation Day 5 and 10 SaO2/FiO2, PaO2/FiO2,Alive and ventilator free Day 14 and 28 Review,Alive and hospital free Day 14 and 28 Review,Alive and SaO2 more than 95% Day 14 and 28 Review,Length of stay Day form admision until discharge Review,length of ICU stay Date form transfer ICU until transfer out review,Ventilator day Date form intubation until extubation Review,Respiratory failure Within hospitalization Review,28-day mortality Within 28 days after enrollment Review,90-day mortality Within 90 days after enrollment Review