Publication Salama C, medRxiv, 2020 (preprint)
Dates: 2020-05-14 to 2020-08-18
Funding: Private (Genentech, Inc.)
Conflict of interest: Yes
Blinding: double blinding
Multicenter / Multinational |
Follow-up duration (days): 60
|Inclusion criteria||1) Patients ≥18 years of age (with no upper age limit)
2) Hospitalized with Covid-19 pneumonia confirmed by a positive polymerase chain reaction test and radiographic imaging
3) Blood oxygen saturation <94% on ambient air
|Exclusion criteria||1) If they required continuous positive airway pressure, bilevel positive airway pressure, or mechanical ventilation.
2) If progression to death was imminent and inevitable within 24 hours as determined by the treating physician
3) Active tuberculosis or suspected active bacterial, fungal, or viral infection (other than SARS-CoV-2 or well-controlled HIV).
4) Patients with comorbidities were not excluded unless the investigator determined it would preclude safe patient participation.
Tocilizumab (8 mg/kg, maximum 800mg.)
Co-Intervention: Standard care
Duration : 1 - 2 days
Duration : 1 - 2 days
388 participants (n1=259 / n2= 129)
|Characteristics of participants|
Mean age : 55.9
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=388 Critical: n=0
|In the register|
|In the report|
Cumulative proportion of patients requiring mechanical ventilation (mechanical invasive ventilation or extracorporeal membrane oxygen) or who had died by Day 28.
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. Study protocol and statistical analysis plan were not available at time of data extraction. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome (cumulative proportion of mechanical ventilation) does not reflect the reported primary outcome (cumulative proportion of mechanical ventilation or death). Some secondary outcomes reported in the registry were not reported in the manuscript. Risk of bias was assessed as high overall due to some concern in 4 of 5 domains for some outcomes and some concern in all domains for other outcomes.|