A phase 2, open label, multicenter, single arm study of tocilizumabon the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia (TOCIVID-19 trial): Statistical Analysis Plan

Publication date: 12/05/2020 – E&P Code: repo.epiprev.it/1610
Authors: Paolo Chiodini1, Laura Arenare2, Maria Carmela Piccirillo2, Francesco Perrone2, Ciro Gallo1

Abstract: Background. Tocilizumab, an IL-6 receptor antagonist, was suggested as a possible treatment of severe or critical COVID-19 pneumonia in a small Chinese study. The TOCIVID-19 trial evaluates efficacy and tolerability of tocilizumab in the treatment of patients with severe or critical COVID-19 pneumonia.
Methods/design. TOCIVID-19is an academic multicenter, single-arm, open-label, phase 2 study. All the patients are being offered a single shot of 8 mg/kg of Tocilizumab (up to a maximum of 800 mg), with an eventual second administration at the discretion of the Investigator. A companion prospective cohort includes either patients not eligible for phase 2 or subjects eligible for phase 2 but exceeding the planned sample size. 14- and 30-days lethality rates are the two co-primary endpoints in the intention-to-treat (ITT) population. Secondary objectives are to evaluate mortality and clinical improvement in the modified-ITT population of subjects who received the drug. Details of the methodological and statistical approaches are reported here reflecting the amendments impelled by the continuously increasing knowledge on COVID-19 progression and troubles in data collection.
Discussion. This paper provides details of planned statistical analyses for TOCIVID19 trial to reduce the risk of reporting bias and increase credibility of the study findings.
TOCIVID-19 trials registered in the EudraCT database with number 2020-001110-38 and in clinicaltrials.gov with ID NCT04317092.

Cite as: Paolo Chiodini, Laura Arenare, Maria Carmela Piccirillo, Francesco Perrone, Ciro Gallo (2020). A phase 2, open label, multicenter, single arm study of tocilizumabon the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia (TOCIVID-19 trial): Statistical Analysis Plan. E&P Repository https://repo.epiprev.it/1610

Topic: COVID-19

Key words: , , ,

AVVERTENZA. GLI ARTICOLI PRESENTI NEL REPOSITORY NON SONO SOTTOPOSTI A PEER REVIEW.

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Affiliations:
1 MedicalStatistics Unit, University of Campania ‘Luigi Vanvitelli’, Napoli, Italy
2 Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy

Authors’ contributions: PC and CG drafted the statistical analysis plan. CG is the senior statistician and supervises all statistical aspects of the trial. PC and LA are responsible fordata quality assessment. MCP is the study coordinating physician. FP is the senior chief investigator, conceived the project and developed the protocol. All authors provided feedback on drafts of this paper and read and approved the final manuscript.

Competing interests: PC, LA and CG have no competing interests. FP and MCP coordinate three academic clinical trials in oncology, promoted by the Istituto Nazionale Tumori di Napoli, that are supported by Roche (clilnicaltrials.gov id: NCT01706120, NCT01802749, NCT02633189)

Funding disclosure: The trial sponsor is the Istituto Nazionale dei Tumori di Napoli. No specific funding was available. The study drug was provided by the pharmaceutical company (Roche) free of charge. 

Ethics committee approval: This is the statistical analysis plan of a clinical trial and no Ethics committee approval is necessary. The TOCIVID-19 trial has been approved on March 18th 2020 by The Ethical Committee of the National Institute of the Infectious Diseases Lazzaro Spallanzani, as National Ethical Committee for COVID-19 trials according to the Italian Decree nr. 18 of March 17th 2020.

Copyright: Il detentore del copyright è l’autore/finanziatore, che ha concesso a “E&P Repository” una licenza per rendere pubblico questo preprint. The copyright holder for this preprint is the author/funder, who has granted E&P Repository a license to display the preprint in perpetuity.

Terms of distribution: CC BY-NC-ND


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