Researchers Marc Bonten And Mihai Netea About The BRACE Trial.

What Is BRACE?

Healthcare professionals and others in close contact with COVID-19 patients, have an increased risk of infection with COVID-19, which is caused by the SARS-CoV-2 virus. There is currently no vaccine or proven preventative treatment available for COVID-19, so protection against infection depends purely on the use of personal protective equipment such as mouth masks to protect healthcare workers. If employees become ill in large numbers and cannot work, the healthcare system will come under greater pressure.

The Bacillus Calmette-Guérin (BCG) vaccine is designed to protect against tuberculosis (TB), but this vaccine may also provide wider protection against other infections. The results of this study may indicate whether BCG vaccination could be used as an early intervention to protect healthcare professionals and other risk groups in future viral outbreaks.

In the BRACE study, 10.000 healthcare professionals are enrolled in Europe and Australia. The institution / hospital where you work will not be informed of your participation in this study. There are no costs for participation and there is no reimbursement for participation. All medications, tests, and medical care needed as part of the study are provided free of charge.

This project is a collaboration between Murdoch Children's Research Institute in Melbourne Australia, Radboud University Nijmegen, and University Medical Centre Utrecht.

Frequently Asked Questions

Can I have a COVID-19 vaccine if I am part of the BRACE trial?
YES. When a COVID-19 vaccine is approved and becomes available, you can continue to participate in the BRACE trial and receive the COVID-19 vaccine. If you do receive a COVID-19-specific vaccine, we will ask you to record the name of the vaccine and the date you received it in the next 3-monthly questionnaire.

Can I participate in a trial assessing a COVID-19 vaccine if I am part of the BRACE trial?
Since the BRACE trial is investigating whether BCG vaccination protects against COVID-19, you should not participate in any other COVID-19 vaccine trial because this will make it difficult to interpret the results of both trials. It is likely that you will not be eligible for another vaccine trial if you are participating in the BRACE trial.

Will the recent results of the BCG-PRIME study affect my participation in the BRACE study?
On 18 January, the first results of another Dutch study with BCG (the BCG-PRIME study) were announced. This study looked at the effect of BCG in frail elderly people.

In the BCG-PRIME study, 6,132 people aged 60 years or older with a chronic illness or recent hospitalization were vaccinated with either BCG or placebo. The results indicate that in this group of vulnerable people over 60, BCG did not prevent COVID-19 disease.
The BCG-PRIME study is still continuing in order to determine whether BCG can reduce the severity of corona infections, or whether it can prevent other serious respiratory infections, in the elderly population.
While the initial results of the BCG PRIME study may seem disheartening, the results of the BRACE study are not yet known. Data collection is still ongoing, and your continued participation is very important. The BCG Prime study differs from the BRACE trial in the following aspects:

• Different population: the population is vulnerable people over 60y (in contrast to well HCW).
• Different primary outcome: in BCG PRIME is symptomatic COVID-19 (in contrast to severe COVID-19 in BRACE).
• Different setting: BRACE is an international study involving countries in 3 continents so additional variables are explored.
• Both BCG PRIME and BRACE have other important non-COVID-19 outcomes still being measured.

We are asking you to please continue with the study visits and surveys as planned. We assure you that we will update you as soon as any BRACE results become available.

When do you expect to see results?
Healthcare workers in the BRACE trial will record their health and any symptoms using a dedicated custom-made smartphone app. Results cannot be expected until sufficient participants have been exposed to the SARS-CoV-2 virus.
Individual results will not become available until the end of the study, when all participants have reached the 12 months endpoint.

Similar trials are underway in many countries. Are these independent researches or are you cooperating with the specialists from other countries?
We are actively collaborating with researchers around the world and will be sharing our results to find a definitive answer as fast as possible.

Participating Hospitals And Registration

UMC Utrecht coordinates a multicentre randomized clinical trial within Europe of the BCG vaccine against COVID-19.
Below you can see which hospitals are participating in the study. 

Participating hospitals	Contact	Phonennumber	Website
Radboudumc, Nijmegen Registration for participation is no longer possible	BRACEstudie.aig@radboudumc.nl		website Radboudumc
Rijnstate, Arnhem Registration for participation is no longer possible	BRACE@rijnstate.nl
Amphia, Breda Registration for participation is no longer possible	BRACE@amphia.nl	076-59 52 061
Noordwest Ziekenhuis, Alkmaar Registration for participation is no longer possible	researchlongziekten@nwz.nl	072-54 84 142
St. Antonius, Nieuwegein Registration for participation is no longer possible	Bracestudie@antoniusziekenhuis.nl
UMCUtrecht, Utrecht Registration for participation is no longer possible	braceumcu@umcutrecht.nl	06-501 77 450

Contact

UMC Utrecht
Heidelberglaan 100
3584 CX Utrecht
BRACE@umcutrecht.nl