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

Contemp Clin Trials. 2020 Nov;98:106165. doi: 10.1016/j.cct.2020.106165. Epub 2020 Oct 6.

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.

Keywords: COVID-19 pneumonia; Phase 2 study; Tocilizumab.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Administration, Intravenous
  • Adult
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • COVID-19* / complications
  • COVID-19* / immunology
  • COVID-19* / physiopathology
  • COVID-19* / therapy
  • Clinical Trials, Phase II as Topic
  • Cytokine Release Syndrome* / drug therapy
  • Cytokine Release Syndrome* / etiology
  • Cytokine Release Syndrome* / immunology
  • Drug Administration Schedule
  • Drug Monitoring
  • Female
  • Humans
  • Immunologic Factors / administration & dosage
  • Immunologic Factors / adverse effects
  • Male
  • Multicenter Studies as Topic
  • Pneumonia, Viral* / drug therapy
  • Pneumonia, Viral* / etiology
  • Receptors, Interleukin-6 / antagonists & inhibitors*
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Immunologic Factors
  • Receptors, Interleukin-6
  • tocilizumab

Associated data

  • ClinicalTrials.gov/NCT04317092