Methylprednisolone vs. Dexamethasone in COVID-19 Pneumonia (MEDEAS RCT) (MEDEAS)
Covid19, Viral Pneumonia Human Coronavirus, Severe Acute Respiratory Syndrome
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Methylprednisolone, Dexamethasone, COVID-19, Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Able to understand and sign the informed consent
- SARS-CoV-2 positive on at least one upper respiratory swab or bronchoalveolar lavage
- PaO2 <= 60 mmHg or SpO2 <= 90% or on oxygen therapy (any), CPAP or NPPV at randomization
- Age >= 18 years old at randomization
Exclusion Criteria:
- On invasive mechanical ventilation (either intubated or tracheostomized)
- Heart failure as the main cause of acute respiratory failure
- On long-term oxygen or home mechanical ventilation
- Decompensated liver cirrhosis
- Immunosuppression (i.e., cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)
- On chronic steroid therapy or other immunomodulant therapy (e.g., azathioprine, methotrexate, mycophenolate, convalescent/hyperimmune plasma)
- Chronic renal failure with dialysis dependence
- Progressive neuro-muscular disorders
- Cognitively impaired, dementia or decompensated psychiatric disorder
- Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
- Do-not-resuscitate order
- Participating in other clinical trial including experimental compound with proved or expected activity against SARS-CoV-2 infection
- Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with protocol intervention
- Refuse to participate in the study or absence of signed informed consent form.
Sites / Locations
- Marco Confalonieri
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Methylprednisolone
Dexamethasone
A. On day 1, loading dose of methylprednisolone (MP) 80 mg IV in 30 minutes, promptly followed by continuous infusion of MP 80 mg/day in 240 mL of normal saline at 10 mL/h. B. From day 2 to day 8: infusion of MP 80 mg/day in 240 mL of normal saline at 10 mL/h. C. From day 9 and beyond: If not intubated patient and PaO2/FiO2 > 200, taper to MP 20 mg IV in 30 minutes three times a day for 3 days, then MP 20 mg IV twice daily for 3 days, then MP 20 mg IV once daily for 2 days, then switch to MP 16 mg/day PO for 2 days, then MP 8mg/day PO for 2 days, then MP 4mg/day PO for 2 days; If intubated patient or PaO2/FiO2 <= 200 with at least 5 cmH2O CPAP, continue infusion of MP 80 mg/day in 240 mL of normal saline at 10 mL/h until PaO2/FiO2 > 200 then taper as in a)
A. Dexamethasone (DM) 6 mg IV in 30 minutes or PO from day 1 to day 10 or until hospital discharge (if sooner). B. After day 10 study treatment is interrupted.