{"id":1604,"date":"2020-05-12T07:30:32","date_gmt":"2020-05-12T07:30:32","guid":{"rendered":"https:\/\/repo.epiprev.it\/?p=1604"},"modified":"2020-05-29T17:32:02","modified_gmt":"2020-05-29T17:32:02","slug":"multicenter-study-on-the-efficacy-and-tolerability-of-tocilizumab-in-the-treatment-of-patients-with-covid-19-pneumonia","status":"publish","type":"post","link":"https:\/\/repo.epiprev.it\/index.php\/2020\/05\/12\/multicenter-study-on-the-efficacy-and-tolerability-of-tocilizumab-in-the-treatment-of-patients-with-covid-19-pneumonia\/","title":{"rendered":"Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia"},"content":{"rendered":"\n

Publication date:<\/strong> 12\/05\/2020 – E&P Code:<\/strong> repo.epiprev.it\/1604<\/a>
Authors:<\/strong> Maria Carmela Piccirillo1<\/sup>, Paolo Ascierto1<\/sup>, Luigi Atripaldi2<\/sup>, Marco Cascella1<\/sup>, Massimo Costantini3<\/sup>, Giovanni Dolci3-4<\/sup>, Nicola Facciolongo3<\/sup>, Fiorentino Fragranza2<\/sup>, AnnaMaria Marata5<\/sup>, Marco Massari3<\/sup>, Vincenzo Montesarchio2<\/sup>, Cristina Mussini4<\/sup>, Emanuele Alberto Negri3<\/sup>, Roberto Parrella2<\/sup>, Patrizia Popoli6<\/sup>, Gerardo Botti1<\/sup>, Laura Arenare1<\/sup>, Paolo Chiodini7<\/sup>, Ciro Gallo7<\/sup>, Carlo Salvarani3-4<\/sup>, Francesco Perrone1<\/sup><\/p>\n\n\n\n

Abstract<\/strong>: Background<\/em><\/strong>: Pneumonia is the most frequent and serious complication of COVID-19, due to an excessive and aberrant host immune response that is associated with an acute respiratory distress syndrome, with typical radiological findings and, in most critical patients, with a “cytokine storm”. IL-6 might play a key role in the cytokine storm induced bySARS-CoV-2 and interfering of IL-6 might be a potentially therapeutic strategy for severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor.<\/p>\n\n\n\n\n\n\n\n

Methods<\/em><\/strong>: This multicentre study project includes a single-arm, single-stage, phase 2 study and a further parallel cohort, enrolling hospitalized patients with COVID-19 pneumonia and oxygen saturation at rest in ambient air \u226493% or requiring respiratory support. All the patients are treated with tocilizumab 8 mg\/kg (up to a maximum of 800 mg) as one intravenous administration. A second administration (same dose) can be given after 12 hours if respiratory function has not recovered. Two-week and one-month lethality rates are the co-primary endpoints. The sample size planned for the phase 2 study is 330 patients. The parallel cohort will include patients who cannot enter the phase 2 study because being intubated from more than 24 hours, or having already received tocilizumab, or the phase 2 study has been closed due to reached sample size. Primary analysis will include patients enrolled in the phase 2 study. Results of the primary analysis will be validated in the prospective cohort of patients consecutively registered after phase 2 closure from March 20 to March 24, who were potentially eligible for the phase 2 study.
Discussion<\/strong><\/em>: This trial aims to verify the safety and efficacy of tocilizumab in the Italian population with COVID-19 pneumonia and respiratory impairment. Study design and conduct has been affected by the health emergency due to coronavirus pandemia in Italy in a time while the number of people who get infected or was hospitalized for respiratory impairment was dramatically increasing.
Trial registration<\/em><\/strong>: EudraCT Number: 2020-001110-38<\/a> registered on Mar 19th<\/sup> 2020 – clinicaltrials.gov<\/a> ID NCT04317092<\/a> registered on Mar 19th<\/sup> 2020<\/p>\n\n\n\n

Cite as<\/strong>: Maria Carmela Piccirillo, Paolo Ascierto, Luigi Atripaldi, et. al. (2020). Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. E&P Repository https:\/\/repo.epiprev.it\/1604<\/a>