Trial NCT04377750
Publication HMO-0224-20, Unpublished, 2021 ( )
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
Placebo * |
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Control
Tocilizumab ( / ) | |
Participants | |
Randomized 54 participants (n1=17 / n2= 37) | |
Characteristics of participants N=54 Mean age : NR 37 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=21 Critical: n=33 | |
Primary outcome | |
In the register Survival [ Time Frame: One-month ] | |
In the report NR | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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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. |