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Methylprednisolone versus dexamethasone in patients with COVID-19

Evaluation of the effectiveness of methylprednisolone versus dexamethasone in patients with COVID-19

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44151777
Enrollment
400
Registered
2022-01-24
Start date
2021-08-15
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

The study presents two groups. The “Rocio Group” is the intervention group, while the “Recovery Group” is the control group. The intervention group received daily intravenous methylpre
Monitoring by the ICU Diarist Physician
monitoring, adjustment of conducts and care of intercurrences by the ICU on-duty Physician (for patients in ICU)
continuous hemodynamic and ventilatory monitoring
monitoring of vital data following the ICU routine (for patients in ICU)
motor and respiratory physiotherapy
ventilatory support measures, invasive or not
hemodynamic support measures, with or without vasopressors, as medically indicated (for patients in ICU)
hydro-electrolyte and acid-base control
medical and general procedures, such as central venous access puncture, closed chest drainage, tracheostomy, among others
use of antimicrobials (antibiotics, antivirals, antifungals, bacteriostatics, etc). according to medical advice
any treatment used adjunct that does not interfere with the evaluation
laboratory routine according to the unit routine and/or medical indication. Follow-up included laboratory data on the third day, on the seventh day, on tenth day of randomization and o

Sponsors

Hospital do Rocio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years. 2. Confirmed or suspected infection for COVID-19. 3. Need for hospitalization, infirmary or intensive care unit (ICU). 4. Chest tomography with image compatible with COVID-19.

Exclusion criteria

Exclusion criteria: 1. Known history of allergy to metrilprednisolone. 2. Use of corticosteroids for another condition. 3. Patient's refusal to participate in the study. 4. Pregnant or breastfeeding women. 5. Contraindication to the use of corticosteroids.

Design outcomes

Secondary

MeasureTime frame
Measured using patient records: 1. Length of hospital stay 2. Need or not for referral to the ICU 3. Length of ICU stay between randomization and day 28 4. Time of mechanical ventilation between randomization and day 28 5. Changes in laboratory standards after 72 hours, 7 days and 10 days of randomization

Primary

MeasureTime frame
All-cause mortality rates at 28 days after randomization measured using patient records

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026