Trial NCT04323592
Publication Salton F, medRxiv, 2020
Dates: 2/27/2020 to 4/24/2020
| Methods | |
| Non-randomized study | |
| Location :
Multicenter / Italy Follow-up duration (days): 28 | |
| Inclusion criteria | Inclusion criteria were the followings: 1) SARS-CoV-2 positive (on swab or bronchial wash); 2) age >18 years and <80 years; 3) PaO2:FiO2 <250 mmHg; 4) bilateral infiltrates; 5) CRP >100 mg/L; and/or 6) diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin definition as an alternative to criteria 4) and 5). |
| Exclusion criteria | Exclusion criteria were: heart failure as main cause of ARF, decompensated liver cirrhosis, immunosuppression (i.e. cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy), dialysis-dependence, on long-term oxygen or home mechanical ventilation, idiopathic pulmonary fibrosis, neuromuscular disorders, dementia or a decompensated psychiatric disorder, severe neurodegenerative conditions, on chronic steroid therapy, pregnancy, a do-not-resuscitate order, and use of Tocilizumab or other experimental treatment. Patients in both study groups received standard of care, comprising noninvasive respiratory support, antibiotics, antivirals, vasopressors, and renal replacement therapy as deemed suitable by the healthcare team. |
| Type of analysis | Multivariable logistic regression |
| Interventions | |
| Treatment
Methylprednisolone (a loading dose of 80 mg iv at study entry (ba) Co-Intervention: Standard care |
|
| Control
Standard care Definition of Standard care: | |
| Participants | |
| N analyzed 173 participants (n1=83 / n2= 90) | |
| Characteristics of participants N=173 Mean age : 65.8 120 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 [ Time Frame: 28 days ] | |
| In the report The composite primary endpoint included admission to ICU, need for invasive MV, or all-cause death by day 28 | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated 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 |
Serious |
| Notes | This is a non-randomized trial. The baseline data are extracted from Table 1. They concern the unadjusted sample (n=173). The time to death HR is adjusted using multivariate logistic regression. In addition to all available versions of the pre-print article, the study registry, a protocol and SAP were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. |