Publication Hermine O, JAMA Intern Med, 2020 (published paper)
Dates: 2020-03-31 to 2020-04-18
Funding: Public/non profit (This trial was publicly funded (Ministry of Health, Programme Hospitalier de Recherche Clinique, Foundation for Medical Research (FRM), AP-HP Foundation and the Reacting program).)
Conflict of interest: No
Multicenter / France |
Follow-up duration (days): 90
|Inclusion criteria||Confirmed SARS-CoV-2 infection (positive on rRT-PCR and/or typical chest computed tomographic [CT] scan) ; Requiring more than 3L/min of oxygen; OMS/WHO progression scale = 5 No NIV or High flow|
|Exclusion criteria||Known hypersensitivity to Tocilizumab or to any of their excipients, Pregnancy ; Current documented bacterial infection, Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication, Absolute neutrophil count (ANC) ≤ 1.0 x 109/L,Haemoglobin level: no limitation, Platelets (PLT) < 50 G /L ; SGOT or SGPT > 5N|
Tocilizumab (8 mg/kg)
Co-Intervention: Standard care
Duration : 1 day (one mor
Definition of Standard care: Usual care (antibiotic agents, antiviral agents, corticosteroids, vasopressor support, anticoagulants) was provided at the discretion of the clinicians.
131 participants (n1=64 / n2= 67)
|Characteristics of participants|
Mean age : 64.8
Severity : Mild: n=0 / Moderate: n=55/ Severe: n=75 Critical: n=0
|In the register|
|In the report|
The 2 primary outcomes were (1) the proportion of patients dead or needing noninvasive or mechanical ventilation on day 4 (>5 on the WHO-CPS); and (2) survival with no need for noninvasive or mechanical ventilation at day 14.
Yes. In English
|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
In addition to the published article, the trial registry, protocol and supplemental materials and the reply provided by authors were used in data extraction and assessment of risk of bias. There were no major differences between trial registry, protocol and published article in procedures and outcomes, and no changes in treatments.
Immunotherapy co-interventions consisted of Anakinra (1 participant in intervention group, 3 in control) and Eculizumab (1 participant in Control). Remdesivir was given to 1 participant in control group.
On October 23rd 2020, we received additional information from authors on this study.