PMC:7195088 / 64212-65750 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7195088","sourcedb":"PMC","sourceid":"7195088","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7195088","text":"Question 6 statement\nOwing to the lack of high-level evidence, administration of tocilizumab in patients with COVID-19 should preferentially occur within the framework of RCT. Off-label use according to local protocols and consent procedures may be considered only in those COVID-19 patients excluded from RCT (or hospitalized where RCT are not available or still to be implemented) and who are worsening while receiving standard supportive care (in the absence of concomitant/superimposed infections). In our opinion, this could be a reasonable off-label use of tocilizumab in these early phases of the COVID-19 pandemic, although patients and physicians should be fully aware that currently there is only a non–peer-reviewed, noncomparative, observational experience (very low evidence from an unreviewed cases series), and that it only supports a potential favourable effect on inflammatory signs and symptoms, while there is no information on any possible effect on survival.\nIn the absence of clinical studies, we suggest that also other immunosuppressive and/or immunomodulatory therapies (e.g. anakinra, Janus kinase family enzyme inhibitors) should be preferentially administered within RCT. This also applies to modifications of the immune response through high-dose intravenous immunoglobulins or plasma from convalescent patients, which, although promising in very small case series, both deserve dedicated RCT investigation to clearly understand their tolerability as well as the role they play in affecting COVID-19 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