Trial NCT04331808
Publication CORIMUNO-TOCI 1 - 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

Methods
RCT
Blinding: Unblinded
Location : Multicenter / France
Follow-up duration (days): 60
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
Interventions
Treatment
Tocilizumab
8 mg/kg IV single dose. An additional dose of 400 mg IV could be administered 2 days later. Additional dose at physician’s discretion
Control
Standard care

Participants
Randomized
participants :
Tocilizumab=64
Standard care=67
Characteristics of participants
N= 131
Mean age : NR
88 males
Severity : Mild: n=0 / Moderate: n=55 / Severe: n=75 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Survival without needs of ventilator utilization at day 14 ; WHO progression scale <=5 at day 4.
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.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

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
Some concerns
General comment 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.
This study was updated on October 23rd 2020, with data received after contact with authors.