BCG vaccination to Reduce the impact of COVID-19 in healthcare workers (BRACE) Trial
- Conditions
- coronavirusSARS-CoV210047438
- Registration Number
- NL-OMON55140
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 545
• Over 18 years of age
• Healthcare worker. This is defined as anyone who works in a healthcare
setting or has face to face contact with patients.
• Provide a signed and dated informed consent form
• Pre-randomisation blood collected
1 Has any BCG vaccine contraindication
o Fever or generalised skin infection (where feasible, randomisation can be
delayed until cleared)
o Weakened resistance toward infections due to a disease in/of the immune
system
o People with any serious underlying illness (such as malignancy)
o Known or suspected HIV infection,11 even if they are asymptomatic or have
normal immune function.
o People with active skin disease such as eczema, dermatitis or psoriasis at or
near the site of vaccination
o Pregnant
o Another live vaccine administered in the month prior to randomisation
o Require another live vaccine to be administered within the month following
BCG randomisation
o Known anaphylactic reaction to any of the ingredient present in the BCG
vaccine
o Previous active TB disease
o Currently receiving long term (more than 1 month) treatment with isoniazid,
rifampicin or quinolone as these antibiotics have activity against
Mycobacterium bovis
2 Previous adverse reaction to BCG vaccine (significant local reaction
(abscess) or suppurative lymphadenitis)
3 BCG vaccine given within the last year
4 Have previously had a SARS-CoV-2 positive test result (positive PCR on a
respiratory sample or a positive SARS-CoV-2 diagnostic antigen test approved by
the local jurisdiction's public health policy)
5 Already part of this trial, recruited at a different hospital.
6 Participation in another COVID-19 prevention trial
7 Have previously received a COVID-19 specific vaccine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Number of participants with COVID-19 disease defined as fever or at least<br /><br>one sign or symptom of respiratory disease including cough, shortness of<br /><br>breath, respiratory distress/failure (using self-reported questionnaire), plus<br /><br>a positive SARS-Cov-2 test (PCR or serology) over the 6 months following<br /><br>randomisation.<br /><br>2. Number of participants with COVID-19 positive test PLUS<br /><br><br /><br>1. Dead (as a consequence of COVID-19 disease)<br /><br>OR<br /><br>2. Hospitalised (including mechanical ventilation and death)<br /><br>OR<br /><br>3. Non-hospitalised severe disease, defined as<br /><br>Non-ambulant for >= 3 consecutive days OR Unable to work for >= 3 consecutive<br /><br>days</p><br>
- Secondary Outcome Measures
Name Time Method