Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured s
- PDF / 448,325 Bytes
- 3 Pages / 595.276 x 790.866 pts Page_size
- 36 Downloads / 129 Views
LETTER
Open Access
Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark Anne Marie Rosendahl Madsen1* , Frederik Schaltz-Buchholzer1, Thomas Benfield2, Morten Bjerregaard-Andersen3, Lars Skov Dalgaard4, Christine Dam5, Sisse Bolm Ditlev6, Gulia Faizi3, Isik Somuncu Johansen7, Poul-Erik Kofoed8, Gitte Schultz Kristensen9, Ellen Christine Leth Loekkegaard10, Christian Backer Mogensen9, Libin Mohamed8, Anne Ostenfeld10, Emilie Sundhaugen Oedegaard1, Marcus Kjaer Soerensen1, Christian Wejse11, Aksel Karl Georg Jensen12, Sebastian Nielsen1, Tyra Grove Krause13, Mihai G. Netea14,15, Peter Aaby1 and Christine Stabell Benn1
Abstract Objectives: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism. The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic. Hypothesis: BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months. Trial design: Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study. Participants: The trial will recruit 1,500 HCW at Danish hospitals. To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week. A potential subject who meets any of the following criteria will be excluded from participation in this study: (Continued on next page)
* Correspondence: [email protected] 1 Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, 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 otherwi
Data Loading...
