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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211017001
Enrollment
120
Registered
2021-10-17
Start date
2021-10-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Covid-19 pneumonia Moderate Covid 19, Moderate pneumonia, Covid 19 pneumonia, Methylprednisolone, Dexamethasone

Interventions

Intravenous methylprednisolone 250 mg per day for 3 days, then intravenous or oral dexamethasone 20 mg per day for 2 days, then intravenous or oral dexamethasone 10 mg per day for 5 days ,Intravenous
Experimental Drug,Active Comparator Drug
Pulse methyprednisolone,High dose dexamethasone

Sponsors

Faculty of Medicine Ramathibodi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Mean of WHO clinical progression scale at day 5 day 5 WHO clinical progression scale

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactJakkrit Laikitmongkhon

Mahidol university

tontenbreak@gmail.com0834509982

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026