Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.
The use of high-dose bolus glucocorticoids in the treatment of patients with COVID-19 infection will increase the anti-inflammatory effect without increasing side effects. This will allow a better patient outcome, reducing the number of deaths and the need for intubation or admission to the Intensive Care Unit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
6 mg/24h - 10 days
250 mg/ 24h - 3 days
Complejo Asistencial Universitario de León
León, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Río Hortega
Valladolid, Spain
Mortality Rate
Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
Time frame: 28 days
Admission in Intensive Unit Care (ICU)
Number of patients who have been admitted to the ICU.
Time frame: 28 days
Evaluation of Respiratory Support Requirements
* Proportion of patients (number of cases with respiratory support requirement / total number of patients) with non-invasive mechanical ventilation and/or high-flow oxygen requirements. * Proportion of patients (number of cases with respiratory support requirement / total number of patients) with invasive mechanical ventilation or intubation requirements.
Time frame: 28 days
Days in Hospital
Number of days in hospital from the star of the treatment until discharge
Time frame: 28 days
Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.
Occurrence of infections, hyperglycaemia, psychotic states or other adverse effects, if applicable
Time frame: 28 days
Evaluation of Other Immunosuppressors Requirements.
Occurrence of use of other immunosuppressors, if applicable
Time frame: 28 days
Status According to the World Health Organization (WHO) 10-category Scale.
Clinical evaluation of patient status according to the WHO 10-category scale. Minimum value: 1 and maximum value: 10, higher scores mean a worse outcome.
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Time frame: 90 days