TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol

Maria Carmela Piccirillo, Paolo Ascierto, Luigi Atripaldi, Marco Cascella, Massimo Costantini, Giovanni Dolci, Nicola Facciolongo, Fiorentino Fraganza, Anna Maria Marata, Marco Massari, Vincenzo Montesarchio, Cristina Mussini, Emanuele Alberto Negri, Roberto Parrella, Patrizia Popoli, Gerardo Botti, Laura Arenare, Paolo Chiodini, Ciro Gallo, Carlo SalvaraniFrancesco Perrone

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Pneumonia is the most frequent complication of COVID-19, due to an aberrant host immune response that is associated with an acute respiratory distress syndrome, and, in most critical patients, with a “cytokine storm”. IL-6 might play a key role in the cytokine storm and might be a potential target to treat severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor. Methods: This multicentre study project includes a single-arm phase 2 study and a further parallel cohort, enrolling hospitalized patients with COVID-19 pneumonia and oxygen saturation at rest in ambient air ≤93% or requiring respiratory support. Patients receive tocilizumab 8 mg/kg (up to 800 mg) as one intravenous administration. A second administration (same dose) after 12 h is optional. Two-week and one-month lethality rates are the co-primary endpoints. 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 h, or having already received tocilizumab, or the phase 2 study has 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. Conclusion: This trial aims to verify the safety and efficacy of tocilizumab in the Italian population with COVID-19 pneumonia and respiratory impairment. EudraCT Number: 2020–001110-38; Clinicaltrials.gov ID NCT04317092

Original languageEnglish
Article number106165
JournalContemporary Clinical Trials
Volume98
DOIs
Publication statusPublished - Nov 2020

Keywords

  • COVID-19 pneumonia
  • Phase 2 study
  • Tocilizumab

ASJC Scopus subject areas

  • Pharmacology (medical)

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