To determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerablel older adults.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The trial has an adaptive primary endpoint. Based on accrual of the two
endpoints , the primary endpoint will be either a) clinically relevant
respiratory tract infections requiring medical intervention, potentially
including COVID-19, or b) laboratory-confirmed and/or physician-diagnosed
COVID-19.The other will be declared secondary endpoint
Secondary outcome
SARS-CoV-2 infection (including asymptomatic infections), influenza infection,
Acute Respiratory Infection, ARI-related hospital admission, COVID-19 related
hospital admission, pneumonia, mental, physical and social functioning, serious
adverse events and adverse events.
Background summary
On March 11 2020 the World Health Organization (WHO) declared the coronavirus
(SARS-CoV-2) outbreak a pandemic. Worldwide, the number of confirmed cases
continues to rise, leading to significant morbidity and mortality. In the
Netherlands, although the incidence is currently low due to social distancing
measures, some experts anticipate a new epidemic peak. Although individuals of
any age can acquire SARS-CoV-2, adults of middle and older age are at highest
risk for developing severe COVID-19 disease. Moreover, recent reports
demonstrate that mortality rates rise significantly among patients 60 years and
older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its
clinical consequences in vulnerable populations are urgently needed. Bacille
Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has
also been shown to induce protection against various respiratory infections,
including those with a viral aetiology. We hypothesize that BCG vaccination may
reduce clinically relevant respiratory tract infections requiring medical
intervention, including COVID-19, in older adults discharged from the
hospital.
Study objective
To determine the impact of BCG vaccination on the incidence of clinically
relevant respiratory infections or COVID-19 in vulnerablel older adults.
Study design
A multi-centre double-blind randomized placebo-controlled trial
Intervention
Participants will be randomized between intracutaneous administration of BCG
vaccine (Danish strain 1331) or placebo (0.1ml 0.9% NaCl) in a 1:1 ratio
Study burden and risks
Burden: Vaccination could cause local pain, suppuration and scarring at the
site of injection. The local reaction after BCG vaccination is usually mild and
self-limiting
Risks: . Less common are fever and headache after vaccination and, if they
occur, they are typically mild. Enlargement of the axillary lymph nodes may
occasionally occur after vaccination but will usually regress spontaneously
after a few months
Heidelberglaan 100
Utrecht 3508 AB
NL
Heidelberglaan 100
Utrecht 3508 AB
NL
Listed location countries
Age
Inclusion criteria
criteria:
* Age *60 years
* Meeting at least one of the following criteria:
a) Having a chronic somatic disease*
b) Having undergone major surgery**
c) Planned to be discharged from the hospital or discharged from the hospital
less than 6 weeks ago; a hospital admission is defined as an overnight stay.
Departments of interest are those that in the opinion of the principle
investigator admit mostly vulnerable elderly and include but are not limited
to: cardiology, pulmonology, internal medicine, neurology.
d) Attending the thrombosis care service
* Written informed consent
Exclusion criteria
* Fever (>38 ºC) within the past 24 hours
* Suspicion of current active viral or bacterial infection; the requirement to
finish an antibiotic course upon discharge is not an exclusion criterion when
the infection is controlled in the opinion of the attending physician
* Vaccination with live vaccine in the past four weeks or planned vaccination
with live vaccine during the next four weeks
* Severely immunocompromised participants
* Known history of a positive Mantoux or active TB enHistory of documented
COVID-19
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-003470-47-NL |
| CCMO | NL74730.041.20 |