Trial N/A
Publication Somers EC, Clin Infect Dis, 2020
Dates: 3/9/2020 to 4/20/2020
| Methods | |
| Non-randomized study | |
| Location :
Single center / USA Follow-up duration (days): 47 | |
| Inclusion criteria | Patients were eligible for inclusion in this analysis if they were admitted to Michigan Medicine from March 9-April 20, 2020 for severe COVID-19 pneumonia, had a reverse-transcriptase polymerase chain reaction positive SARS-CoV-2 test, and required invasive mechanical ventilation. |
| Exclusion criteria | Patients were excluded if they were younger than 16 years, were intubated for conditions unrelated to COVID-19, or were enrolled into a randomized controlled trial (RCT) for sarilumab. Untreated patients who died prior to the opportunity to receive tocilizumab treatment per institutional criteria (within 48 hours of intubation) were excluded to minimize immortal time bias. |
| Type of analysis | Propensity score inverse probability weighting |
| Interventions | |
| Treatment
Tocilizumab (8 mg/kg) Co-Intervention: Standard care |
|
| Control
Standard care (8 mg/kg (max 800mg)) Definition of Standard care: Based on available evidence and lack of enrolling clinical trials at local onset of the pandemic, hydroxychloroquine 600 mg every twelve hours x2 doses, then 200 mg every 8 hours was recommended as standard management at the beginning of the study period. Once remdesivir studies were activated, hydroxychloroquine was formally removed from our guidelines on March 26, 2020, and treatment with hydroxychloroquine was rare after these changes. Adjunctive corticosteroid use was generall | |
| Participants | |
| N analyzed 154 participants (n1=78 / n2= 76) | |
| Characteristics of participants N=154 Mean age : 57,5 102 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report survival probability after intubation | |
| 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 | This is a quasi-experimental study. The pre-print article with it's supplementary appendix was used in the extraction and risk of bias assessment. The baseline data are extracted from Table 1. They concern the unadjusted sample. The mortality, time to death HR and clinical improvement OR extracted concern the IPTW adjusted sample after multiple imputation for missing baseline data (n=154; no baseline data were reported for this population). No registration or protocol were available. The extraction and risk of bias assessment for this study was updated with the published report and supplementary appendix on 17/07/2020. |