Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A
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Open Access
Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial Pradeesh Sivapalan1,2, Charlotte Suppli Ulrik3, Rasmus Dahlin Bojesen4, Therese Sophie Lapperre5, Josefin Viktoria Eklöf1, Kjell Erik Julius Håkansson3, Andrea Browatzki6, Casper Tidemansen3, Jon Torgny Wilcke1, Julie Janner3, Vibeke Gottlieb1, Howraman Meteran1, Celeste Porsbjerg5, Birgitte Lindegaard Madsen6, Mia Moberg3, Lars Pedersen5, Thomas Lars Benfield7, Jens Dilling Lundgren8, Filip Krag Knop9, Tor Biering-Sørensen10, Muzhda Ghanizada5, Tine Peick Sonne1, Uffe Christian Steinholtz Bødtger2,11,12, Sidse Graff Jensen1, Daniel Bech Rasmussen11, Eva Brøndum3, Oliver Djurhuus Tupper3, Susanne Wiemann Sørensen3, Gitte Alstrup11, Christian Borbjerg Laursen13, Ulla Weinrich Møller14, Asger Sverrild5 and Jens-Ulrik Stæhr Jensen1*
Abstract Objectives: The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death. Trial design: This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study. Participants: 226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals. Inclusion criteria: • Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years (Continued on next page)
* Correspondence: [email protected] 1 Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, 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 included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.o
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