Trial *
Publication Mikulska, M, medRxiv, 2020
Dates: 2020-03-01 to 2020-04-30
| Methods | |
| Non-randomized study | |
| Location :
Single center / Italy Follow-up duration (days): 53 | |
| Inclusion criteria | Patients admitted for COVID-19 pneumonia were included as cases if treated with tocilizumab and/or methylprednisolone, not intubated, not treated with remdesivir and not pregnant. |
| Exclusion criteria | NR |
| Type of analysis | Propensity score stratification/adjustment |
| Interventions | |
| Treatment
Tocilizumab and/or Methylprednisolone (8 mg/kg (maximum 800 mg)/1mg/kg for 5 days intravenously, then 0.5mg/kg for 5 days) Co-Intervention: Standard care Duration : 5 days |
|
| Control
Standard care Definition of Standard care: Patients received treatment with oral hydroxychloroquine 400mg bid, unless glucose-6-phosphate dehydrogenase deficient. Until March 24th, darunavir/ritonavir 800/100 qd was also administered. Thereafter, the protocol was amended and darunavir/ritonavir was withdrawn. Short-term antibiotic coverage was prescribed at admission. Low-molecularweight heparin prophylaxis was administered unless contraindicated. These treatments were defined as SOC. Patients received treatment with oral hydroxychloroquine 400mg bid, unless glucose-6-phosphate dehydrogenase deficient. Until March 24th, darunavir/ritonavir 800/100 qd was also administered [17]. Thereafter, the protocol was amended and darunavir/ritonavir was withdrawn [18]. Short-term antibiotic coverage was prescribed at admission. Low-molecularweight heparin prophylaxis was administered unless contraindicated.These treatments were defined as SOC. Patients received treatment with oral hydroxychloroquine 400mg bid, unless glucose-6-phosphate dehydrogenase deficient. Until March 24th, darunavir/ritonavir 800/100 qd was also administered [17]. Thereafter, the protocol was amended and darunavir/ritonavir was withdrawn [18]. Short-term antibiotic coverage was prescribed at admission. Low-molecularweight heparin prophylaxis was administered unless contraindicated.These treatments were defined as SOC. | |
| Participants | |
| N analyzed 196 participants (n1=130 / n2= 66) | |
| Characteristics of participants N=* Mean age : 67.5 132 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report The primary end point was time to failure, defined as intubation and mechanical ventilation or death, whichever occurred first, within 30 days from the hospital admission | |
| Documents avalaible |
Protocol NR Statistical plan NR 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 |