Trial NCT04377750
Publication HMO-0224-20 - HMO-0224-20, Unpublished (2021) (unpublished results)
Dates: 2020-04-08 to 2021-02-03
Funding: Public/non profit (Hadassah Medical Organization)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Israel
Follow-up duration (days): 90
Inclusion criteria
  • Any gender
  • Age 18 and older
  • Informed consent for participation in the study
  • Virological diagnosis of Sars-CoV2 infection (PCR)
  • Acute respiratory failure
  • Radiographic pneumonia, defined as any/ changing new lung infiltrate
  • Patient breathing spontaneously, required more than 50% oxygen and MEWS score > 7
  • If intubated, intubated less than 24 hours with PaO2/Fio2 ratio ≤ 200 and PEEP ≥ 5 cm H2O
Exclusion criteria
  • Known hypersensitivity to tocilizumab or its excipients
  • Patient with a life expectancy of less than 6 months
  • Known active infections or other clinical condition that contra-indicate tocilizumab and cannot be treated or solved according to the judgement of the clinician
  • Neutrophils <500 / mmc
  • Platelets <40.000 / mmc
Interventions
Treatment
Tocilizumab
8mg/kg (max 800mg) IV single dose
Control
Placebo

Participants
Randomized
participants :
Placebo=17
Tocilizumab=37
Characteristics of participants
N= 54
Mean age : NR
37 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=21 Critical: n=33
Number of vaccinated participants: NR
Primary outcome
In the register
Survival [ Time Frame: One-month ]
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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
High
General comment The study is not yet published. Data presented was extracted from study registry and The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group "Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis." JAMA. 2021;326(6):499–518. The authors have been contacted in order to obtain the results.