Covid-19 Living Data

Trial NCT04673162 ; EudraCT 2020-004323-16
Publication Salvarani C, Eur Respir J (2022) (published paper)
Dates: 2020-12-21 to 2021-03-10
Funding: No specific funding (This research received no external funding. The coordinator centre and all participating centres are using local resources to conduct the trial.)
Conflict of interest: No

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / Italy Follow-up duration (days): 30
Inclusion criteria	Patients hospitalized for recent-onset COVID-19 pneumonia documented by radiological imaging confirmed by polymerase chain reaction method with nasopharyngeal swab more than five days since initial symptoms of infection requiring supplemental oxygen in any delivery mode, except invasive mechanical ventilation PaO2/FiO2 between 100 and 300 a C-reactive protein (CRP) greater than 5 mg/dL.
Exclusion criteria	Required invasive mechanical ventilation shock or concomitant organ failure requiring an Intensive Care Unit (ICU) admittance pregnancy or breastfeeding severe cardiac or renal failure diabetes not in good metabolic control based on physician’s clinical judgment other clinical conditions which contraindicate methylprednisolone and which cannot be treated or resolved based on physician’s clinical judgment therapy with steroid high dose pulses in the week preceding the enrolment in the study enrolment in another clinical trial.
Interventions
	Treatment Methylprednisolone 1 g/day intravenously in 100 ml once a day for 3 days
	Control Placebo
Participants
	Randomized participants : Methylprednisolone=152 Placebo=152
	Characteristics of participants N= 304 Mean age : NR 217 males Severity : Mild: n=0 / Moderate: n=205 / Severe: n=96 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Length of hospitalization [Time Frame: 30 days since randomisation] the interval between randomization and discharge from the hospital without the need for supplemental oxygen
	In the report The duration of the patient hospitalisation, calculated as the interval of time between the randomisation and the hospital discharge without the need of supplementary oxygen during the first 30 days following randomisation.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Low
General comment	In addition to the published article, the prospective registries and supplementary appendices were used in data extraction and assessment of risk of bias. The protocol and statistical analysis plan referred to as supplementary appendices in the early view article were not accessible at time of extraction. The primary outcome in the article reflects that in the registry. The trial (n = 304) achieved its target sample size (n = 260).