Tocilizumab is an IL-6 receptor-blocking agent proposed for the treatment of severe COVID-19. The aim of this systematic review was to describe the rationale for the use of tocilizumab for the treatment of COVID-19 and to summarize the available evidence regarding its efficacy and safety.
Methods
MEDLINE, PubMed, EMBASE, pre-print repositories (bioRxiv and medRxiv) and two trial Registries were searched for studies on the use of tocilizumab in COVID-19 or SARS-CoV-2 infection, viral pneumonia, and/or sepsis until 20th June 2020.
Results
We identified 3 indirect pre-clinical studies and 28 clinical studies including 5776 patients with COVID-19 (13 with a comparison group, 15 single-arm). To date, no randomized trials have been published. We retrieved no studies at low risk of bias. Forty-five ongoing studies were retrieved from trial registries.
Conclusions
There is insufficient evidence regarding the clinical efficacy and safety of tocilizumab in patients with COVID-19. Its use should be considered experimental, requiring ethical approval and clinical trial oversight.
Abbreviations
AIFA
Agenzia Italiana del Farmaco
ARDS
Acute respiratory distress syndrome
COVID-19
Coronavirus disease 2019
CPAP
Continuous positive airway pressure
CRS
CAR-T cell-induced cytokine release syndrome
GCA
Giant cell arteritis
ICTRP
International Clinical Trials Registry Platform
IDSA
Infectious Diseases Society of America
IMV
Invasive mechanical ventilation
NIH
U.S. National Institutes of Health
NIV
Noninvasive mechanical ventilation
pJIA
Pediatric juvenile idiopathic arthritis
RA
Rheumatoid arthritis
SIMIT
Italian Society of Infectious and Tropical disease
