Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome

CompletedOBSERVATIONAL
Enrollment

173

Participants

Timeline

Start Date

March 23, 2020

Primary Completion Date

May 10, 2020

Study Completion Date

May 10, 2020

Conditions
Severe Acute Respiratory Syndrome (SARS) PneumoniaCoronavirus InfectionsARDS, Human
Interventions
DRUG

Methylprednisolone

Usual standard of care plus Methylprednisolone (MP) 80 mg/kg IV bolus, followed by MP infusion of 80 mg/day in 240 mL normal saline at 10 mL/h. The infusion is continued for at least eight days and until achieving either a PaO2:FiO2 \> 350 mmHg or a CRP \< 20 mg/L. Treatment is then switched to oral administration of Methylprednisolone 16 mg or 20 mg IV twice daily until CRP returns to \< 20% of normal range and/or PaO2:FiO2 \> 400 or SatHbO2 ≥ 95%. The decision to apply the protocol to Covid-19 is left to the discretion of the treating team for each individual patient.

OTHER

standard care

"usual standard of care:~* oxygen therapy (regular or high-flow) and monitoring~* empiric antibiotic therapy~* mechanical ventilation (invasive or noninvasive)~* ECMO when needed and available~* pronation when possible~* other treatment which can be used are: antivirals, chloroquine, vitamins"

Trial Locations (1)

34149

Marco Confalonieri, Trieste

All Listed Sponsors
lead

University of Trieste

OTHER

NCT04323592 - Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome | Biotech Hunter | Biotech Hunter