| Methods |
Trial design: randomised, multicentre, double‐blind study
Sample size: 260
Setting: inpatient
Language: Italian, English
Number of centres: 5
Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria
Age = 18 years Informed consent for participation in the study and for data processing Molecular diagnosis with PCR test of Sars‐CoV2 infection Hospitalisation in a specialist ward for COVID‐19 patient care (e.g. Infectious Diseases, Pulmonology or Internal Medicine) Need for supplemental oxygen in any delivery mode with the exception of IMV PaO2/FiO2 between 100 and 300 mmHg Clinical/instrumental diagnosis (high‐resolution chest CT scan or chest X‐ray or lung ultrasound) of interstitial pneumonia for no more than 3 days Serum CRP > 5 mg/dL Interval from onset of SARS‐CoV2 infection symptoms to randomisation > 5 days
Exclusion criteria
IMV Presence of shock or concomitant organ failure that requires admission to the ICU Pregnancy or breastfeeding Severe heart or kidney failure Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception Diabetes not compensated according to the doctor's judgement Other clinical conditions that contraindicate methylprednisolone and cannot be treated or resolved according to the doctor's judgement Steroid bolus therapy in the week prior to enrolment for the study Enrolment in another clinical trial Patient already randomised in this study
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| Interventions |
Details of intervention:
Treatment details of control group (e.g. dose, route of administration): placebo, IV
Concomitant therapy: no information |
| Outcomes |
Primary study outcome: length of hospitalisation, calculated as the interval between randomisation and discharge from the hospital without the need for supplemental oxygen |
| Notes |
Recruitment status: completed
Prospective completion date: 4‐month trial duration planned
Date last update was posted: 25 November 2020
Sponsor/funding: Azienda Ospedaliera Arcispedale Santa Maria Nuova/IRCCS Di Reggio Emilia |
