key: cord-0776602-8b9ra7ws
authors: Di Giambenedetto, Simona; Ciccullo, Arturo; Borghetti, Alberto; Gambassi, Giovanni; Landi, Francesco; Visconti, Elena; Zileri Dal Verme, Lorenzo; Bernabei, Roberto; Tamburrini, Enrica; Cauda, Roberto; Gasbarrini, Antonio
title: Off‐label Use of Tocilizumab in Patients with SARS‐CoV‐2 Infection
date: 2020-04-16
journal: J Med Virol
DOI: 10.1002/jmv.25897
sha: 7f581e6a125701e4d7a34c38d98e14a4e5bf26ca
doc_id: 776602
cord_uid: 8b9ra7ws

The spread of the novel‐Coronavirus infection worldwide represents a challenge for physicians. Particularly, no approved therapy has demonstrated to have an impact in treating patients who develop severe respiratory insufficiency so far. The use of humanized anti‐human inteleukine‐6 receptor antibody tocilizumab seems a promising strategy for these patients. This article is protected by copyright. All rights reserved.

we read with interest the work by Pan et al. 1 , who described the use of tociluzumab in 15 patients with moderate-to-critical novel coronavirus infection (COVID-19) caused by SARS-CoV-2.

The emergence of COVID-19 in the Hubei province of China in early 2020 and its rapid global spread, poses a great challenge for healthcare systems worldwide 2 . No specific treatment for COVID-19 is currently available 3 , with lopinavir/ritonavir failing to demonstrate superior efficacy compared with standard care 4 and clinical trials evaluating the efficacy of remdesivir 5 and chloroquine 6 currently underway. Recently, much interest has been aroused by the possibility of using tocilizumab, a humanized anti-human inteleukine-6 receptor antibody of the IgG1 subclass, with the rationale of preventing or treating the cytokine storm that has been observed in patients progressing to cardiovascular collapse, multiple organ dysfunction and death 7 .

Data on the use of this molecule in the treatment of SARS-CoV-2 infection are still preliminary but the promising results have prompted the Chinese Health Commission to update its national guidelines to include tocilizumab for the treatment of severe COVID-19 8 . Italian guidelines 9 also support the use of tocilizumab (at the dosage of 8 mg/kg, with a second dose 12 hours after the first and a possible third dose after further 24-36 hours, according to clinical response), in case of rapid clinical and/or radiological worsening, after excluding contraindications to its use (transaminases levels> 5 times the upper limit of normal, neutrophils count<500 cells/µL, platelets count< 50,000 cells/µL, presence of documented sepsis, complicated diverticulitis/intestinal perforation, cutaneous infection, immunesuppressive anti-rejection therapy).

We hereby describe the outcomes of 3 patients hospitalized in a III level Italian Hospital following the diagnosis of COVID-19 by real-time PCR on oropharyngeal and nasopharyngeal swabs, and developing rapid respiratory insufficiency. They were prescribed tocilizumab after verbal consent to drug administration, and they also agreed to clinical data collection for study purposes. Despite the lack of IL-6 levels determination for selecting the best candidates to tocilizumab therapy at the time of our case series, our work gives further evidence that tocilizumab may represent an effective and safe option in the treatment of SARS-CoV-2infected patients with severe pneumonia. Randomized trials are urgently needed to confirm our findings.

This study was performed as part of our routine work.

The Authors have no financial or non-financial interest in the subject matter or materials discussed in this manuscript.

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Gilead Sciences Statement on the Company's Ongoing Response to the 2019 Novel Coronavirus

A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19

Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study