{"id":1610,"date":"2020-05-12T07:46:31","date_gmt":"2020-05-12T07:46:31","guid":{"rendered":"https:\/\/repo.epiprev.it\/?p=1610"},"modified":"2020-05-29T17:32:43","modified_gmt":"2020-05-29T17:32:43","slug":"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-anal","status":"publish","type":"post","link":"https:\/\/repo.epiprev.it\/index.php\/2020\/05\/12\/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-anal\/","title":{"rendered":"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"},"content":{"rendered":"\n<p class=\"has-small-font-size\"><strong>Publication date:<\/strong> 12\/05\/2020 &#8211;  <strong>E&amp;P Code:<\/strong>  <a rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\" href=\"https:\/\/repo.epiprev.it\/1610\" target=\"_blank\">repo.epiprev.it\/1610<\/a>   <br><strong>Authors:<\/strong> Paolo Chiodini<sup>1<\/sup>, Laura Arenare<sup>2<\/sup>, Maria Carmela Piccirillo<sup>2<\/sup>, Francesco Perrone<sup>2<\/sup>, Ciro Gallo<sup>1<\/sup><\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Abstract<\/strong>: <strong><em>Background<\/em><\/strong>. 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.<br><strong><em>Methods\/design<\/em><\/strong>. 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.<br><strong><em>Discussion<\/em><\/strong>. 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.<br>TOCIVID-19 trials registered in the EudraCT database with number <a rel=\"noreferrer noopener\" href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=2020-001110-38\" target=\"_blank\">2020-001110-38<\/a> and in <a rel=\"noreferrer noopener\" href=\"http:\/\/clinicaltrials.gov\" target=\"_blank\">clinicaltrials.gov<\/a> with ID <a rel=\"noreferrer noopener\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04317092\" target=\"_blank\">NCT04317092<\/a>.<\/p>\n\n\n\n<!--more-->\n\n\n\n<p class=\"has-small-font-size\"><strong>Cite as<\/strong>: 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 <a href='https:\/\/repo.epiprev.it\/1610'>https:\/\/repo.epiprev.it\/1610<\/a><button title=\"Copia citazione\" id=\"copyTextCite\"><span class=\"far fa-copy\"><\/span><\/button><\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Topic<\/strong>: <a href='\/index.php\/category\/COVID-19'>COVID-19<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Key words<\/strong>: <a href=\"https:\/\/repo.epiprev.it\/index.php\/tag\/covid-19\/\" rel=\"tag\">COVID-19<\/a>, <a href=\"https:\/\/repo.epiprev.it\/index.php\/tag\/studio-di-fase-due\/\" rel=\"tag\">studio di fase due<\/a>, <a href=\"https:\/\/repo.epiprev.it\/index.php\/tag\/tocilizumab\/\" rel=\"tag\">tocilizumab<\/a>, <\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>AVVERTENZA. GLI ARTICOLI PRESENTI NEL REPOSITORY NON SONO SOTTOPOSTI A PEER REVIEW.<\/strong><\/p>\n\n\n\n<div class='w3eden'><!-- WPDM Link Template: Default Template -->\n\n\n<div class=\"link-template-default card mb-2\">\n    <div class=\"card-body\">\n        <div class=\"media stack-xs\">\n            <div class=\"media-body\">\n                <div class=\"media\">\n                    <div class=\"mr-3 img-48\"><img decoding=\"async\" class=\"wpdm_icon\" alt=\"Icona\" src=\"https:\/\/repo.epiprev.it\/wp-content\/plugins\/download-manager\/assets\/file-type-icons\/pdf.svg\" onError='this.src=\"https:\/\/repo.epiprev.it\/wp-content\/plugins\/download-manager\/assets\/file-type-icons\/unknown.svg\";' \/><\/div>\n                    <div class=\"media-body\">\n                        <h3 class=\"package-title\"><a href='https:\/\/repo.epiprev.it\/index.php\/download\/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\/'>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<\/a><\/h3>\n                        <div class=\"text-muted text-small\"><i class=\"fas fa-file-download\"><\/i> 53 Download <i class=\"fas fa-hdd ml-3\"><\/i> 778.25 KB<\/div>\n                    <\/div>\n                <\/div>\n            <\/div>\n            <div class=\"ml-3 wpdmdl-btn\">\n                <a class='wpdm-download-link btn btn-primary ' rel='nofollow' href='#' onclick=\"location.href='https:\/\/repo.epiprev.it\/index.php\/download\/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\/?wpdmdl=1616&refresh=69d2b32280fdd1775416098';return false;\">Download<\/a>\n            <\/div>\n        <\/div>\n\t\t\n    <\/div>\n<\/div>\n\n\n<\/div>\n\n\n\n<h4 class=\"wp-block-heading\">Info<\/h4>\n\n\n\n<p class=\"has-small-font-size\"><strong>Affiliations<\/strong>: <br><sup>1 <\/sup>MedicalStatistics Unit, University of Campania \u2018Luigi Vanvitelli\u2019, Napoli, Italy<br><sup>2<\/sup> Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy<\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Authors&#8217; contributions: <\/strong>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.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Competing interests: <\/strong>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 (<a rel=\"noreferrer noopener\" href=\"http:\/\/clilnicaltrials.gov\" target=\"_blank\">clilnicaltrials.gov<\/a> id: <a rel=\"noreferrer noopener\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01706120\" target=\"_blank\">NCT01706120<\/a>, <a rel=\"noreferrer noopener\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01802749\" target=\"_blank\">NCT01802749<\/a>, <a rel=\"noreferrer noopener\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02633189\" target=\"_blank\">NCT02633189<\/a>)<\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Funding disclosure:<\/strong> 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.\u2003<\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Ethics committee approval: <\/strong>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 18<sup>th<\/sup> 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 17<sup>th<\/sup> 2020.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Copyright<\/strong>:  Il detentore del copyright \u00e8 l\u2019autore\/finanziatore, che ha concesso a \u201cE&amp;P Repository\u201d una licenza per rendere pubblico questo preprint. The copyright holder for this preprint is the author\/funder, who has granted E&amp;P Repository a license to display the preprint in perpetuity.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Terms of distribution<\/strong>: <a rel=\"noreferrer noopener\" href=\"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/deed.it\" target=\"_blank\">CC BY-NC-ND<\/a> <\/p>\n\n\n\n<hr \/><img src='https:\/\/repo.epiprev.it\/wp-content\/uploads\/2020\/05\/data-3938447_12801.jpg' alt=\"data-3938447_1280[1]\" class='attachment-post-thumbnail size-post-thumbnail wp-post-image' \/><p class='has-small-font-size'>Immagine redazionale con funzione decorativa, non facente parte del pre-print. Fonte: https:\/\/pixabay.com (3938447 mohamed_hassan)<\/p><hr \/>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-background has-small-font-size has-light-gray-background-color\"><strong>References &amp; Citations<\/strong><br><a rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\" href=\"https:\/\/scholar.google.com\/scholar?q=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\" target=\"_blank\">Google Scholar<\/a><\/p>\n\n\n\n<p><a href=\"http:\/\/www.facebook.com\/sharer.php?u=https:\/\/www.repo.epiprev.it\/1610\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"Condividi su Facebook\"><img decoding=\"async\" src=\"\/wp-content\/uploads\/2020\/04\/icon_facebook.png\"><\/a><a href=\"https:\/\/twitter.com\/intent\/tweet?url=https:\/\/www.repo.epiprev.it\/1610\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"Condividi su Twitter\"><img decoding=\"async\" src=\"\/wp-content\/uploads\/2020\/04\/icon_twitter.png\"><\/a><a class=\"icon_whatsapp\" href=\"https:\/\/api.whatsapp.com\/send?text=https%3A%2F%2Frepo.epiprev.it\/1610&amp;attribution=AMPhtml&amp;url=https%3A%2F%2Frepo.epiprev.it\/1610\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"Invia con WhatsApp\"><img decoding=\"async\" src=\"\/wp-content\/uploads\/2020\/04\/icon_whatsapp.png\"><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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<\/p>\n","protected":false},"author":1,"featured_media":1689,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[16,95,94],"class_list":["post-1610","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-covid-19","tag-covid-19","tag-studio-di-fase-due","tag-tocilizumab"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - 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