Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a
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Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan Pradeesh Sivapalan1* , Charlotte Suppli Ulrik2, Therese Sophie Lappere3, Josefin Viktoria Eklöf1, Saher Burhan Shaker1, Uffe Christian Steinholtz Bødtger4, Andrea Browatzki5, Christian Niels Meyer6, Ulla Møller Weinreich7, Christian B. Laursen8, Tor Biering-Sørensen1, Filip Krag Knop1, Jens D. Lundgren9 and Jens-Ulrik Stæhr Jensen1
Abstract Background: There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease. Methods: The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis. Discussion: This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency. Trial registration: ClinicalTrials.gov NCT04322396. Registered on 26 March 2020. Keywords: Detailed statistical analysis plan, Randomized controlled trial, Infectious diseases, Safety, Hydroxychloroquine, Azithromycin, Intervention
* Correspondence: [email protected] This document has been written based on information contained in the study protocol version 1.8, dated 16th of April 2020 1 Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are includ
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