https://www.socictopen.socict.org/index.php/items/show/3860
title: Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials
subject: elderly, healthcare workers, Randomised controlled trial, protocol, BCG vaccine, COVID-19
description: Abstract Objectives The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination. Trial design Two separate multi-centre placebo-controlled parallel group randomized trials Participants (1) Health care personnel working in the hospital or ambulance service where they will take care of patients with the COVID-19 infection and (2) elderly ≥60 years. The HCW trial is being undertaken in 9 hospitals. The elderly trial is being undertaken in locations in the community in Nijmegen, Utrecht, and Veghel, in the Netherlands, using senior citizen organisations to facilitate recruitment. Intervention and comparator For both trials the intervention group will be randomized to vaccination with 0.1 ml of the licensed BCG vaccine (Danish strain 1331, SSI, Denmark, equivalent to 0.075 mg attenuated M. bovis). The placebo group consists of 0.1 ml 0.9% NaCl, which is the same amount, and has the same colour and appearance as the suspended BCG vaccine. Main outcomes (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. Randomisation Participants will be randomized to BCG vaccine or placebo (1;1) centrally using a computer- based system, stratified by study centre. Blinding (masking) Subjects, investigators, physicians and outcome assessors are blinded for the intervention. Only the pharmacist assistant that prepares- and research personnel that administers- study medicines are unblinded. Numbers to be randomised (sample size) (1) The sample size for the first trial is N=1500 HCWs randomised 1:1 to either BCG vaccine (n=750) and placebo (n=750) and (2) The sample size for the second trial is N=1600 elderly persons randomised to BCG vaccine (n=800) and the placebo group (n=800). Trial…
creator: Mihai G. Netea, Reinout Van Crevel, Janneke van de Wijgert, Chantal P. Bleeker-Rovers, Cornelis H van Werkhoven, Jaap Ten Oever, Marc J Bonten, Thomas W. van der Vaart, Patricia Bruijning-Verhagen, Thijs ten Doesschate, Simone J.C.F.M. Moorlag, Arief Lalmohamed, Rob ter Heine, Axel B. Janssen, Esther Taks, Priya Debisarun, on behalf of the BCG-CORONA study team#
source: Trials
publisher: BMC
date: 2020
identifier: DOI: 10.1186/s13063-020-04389-w
coverage: Medicine (General)