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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a retrospective, single center analysis of 74 patients consecutively admitted to hospital in Milan (Italy), with a diagnosis of COVID-19 and who started tocilizumab treatment from 13 March 2020 to 3 April 2020, a patient [age and sex not stated] was described, who developed septic shock following off-label use of tocilizumab for COVID-19 infection.
The patient, who was diagnosed with COVID-19 infection and was admitted to the ICU, received off-label treatment with tocilizumab infused at 8 mg/kg over 60 min (with a maximum dose of 800 mg) and a second dose administered after 12 h. Subsequently, the patient developed septic shock [duration of treatment to reaction onset not stated] and died due to it after ICU discharge.
Reference
- Rossotti R, et al. Safety and efficacy of anti-il6-receptor tocilizumab use in severe and critical patients affected by coronavirus disease 2019: A comparative analysis. Journal of Infection 81: e11-e17, No. 4, Oct 2020. Available from: URL: 10.1016/j.jinf.2020.07.008 [DOI] [PMC free article] [PubMed]