SARS-CoV-2 infection MedDRA version: 20.0 Level: HLT Classification code 10047490 Term: Virus identification and serology System Organ Class: 100000004848
Conditions
Interventions
Trade Name: BCG Vaccin SSI (Netherlands Vaccin Statens Serum Institute) Danish strain 1331
Pharmaceutical Form: Concentrate and solvent for solution for injection
Pharmaceutical form of the placebo: C
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Over 18 years of age • Healthcare worker • Provide a signed and dated informed consent form • Pre-randomisation blood collected Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine if BCG vaccination (Intervention) compared with placebo (Comparator) reduces the incidence of COVID-19 disease (Outcome) measured over the 6 months following randomisation (Time) in healthcare workers exposed to SARS-CoV-2 (Participants). 2. To determine if BCG vaccination (Intervention) compared with placebo (Comparator) reduces the incidence of severe COVID-19 disease (with COVID 19 related death, hospitalisation, or non-hospitalised severe disease (defined as Non-ambulant1 for = 3 consecutive days OR Unable to work2 for = 3 consecutive days) (Outcome) measured over the 6 months following randomisation (Time) in healthcare workers exposed to SARS-CoV-2 (Participants). ;Secondary Objective: 3. To determine if BCG vaccination compared with placebo reduces the incidence of COVID-19 disease measured over the 12 months 4. To determine if BCG vaccination compared with placebo reduces the incidence of severe COVID-19 disease measured over the 12 months 5. To determine if BCG vaccination compared with placebo prolongs the time to first SARS-CoV-2-proven respiratory illness measured over 6 and 12 months 6. To determine if BCG vaccination compared with placebo reduces the severity of COVID-19 disease measured over 6 and 12 months 7. To determine if BCG vaccination compared with placebo reduces the rate and severity of illness measured over 6 and 12 months 8. To determine if BCG vaccination compared with placebo reduces absenteeism in healthcare workers 9. To evaluate the safety of BCG vaccination in adult healthcare workers. ;Primary end point(s): Number of participants with COVID-19 disease Number or participants with severe of COVID-19 disease ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of participants with COVID-19 disease Number or participants with severe of COVID-19 disease Time to first symptom of COVID-19 in a participant Number of episodes of COVID-19 disease Number of participants with asymptomatic SARS-CoV-2 infection Number of days unable to work due to COVID-19 disease Number of days confined to bed due to COVID-19 disease Number of days with symptoms in any episode of illness for COVID-19 disease Number of pneumonia cases (abnormal chest X-ray) associated with a positive SARS-CoV-2 test Need for oxygen therapy associated with a positive SARS-CoV-2 test Number of admission to critical care and duration of stay associated with a positive SARS-CoV-2 test Need of mechanical ventilation and duration and a positive SARS-CoV-2 test Duration of hospitalisation due to COVID-19 Number of deaths associated with a positive SARS-CoV-2 test Number of participants with fever or respiratory illnessNumber of episodes of fever or respiratory illness Number of days unable to work due to fever or respiratory illness Number of days confined to bed due to fever or respiratory illness Number of days with symptoms in any episode of illness Number of pneumonia cases (abnormal chest X-ray) Need for oxygen therapy Number of admission to critical care Need of mechanical ventilation Number of deaths Duration of hospitalisation due to fever or respiratory illness Number of days of unplanned absenteeism for any reason Hospital-related health costs associated with participant hospitalisation Type and severity of local and systemic adverse event over the 3 months ;Timepoint(s) of evaluation of this end point: 3, 6, 9 and 12 months | — |
Countries
Australia, Brazil, Netherlands, Spain, United Kingdom
Contacts
Public Contactsponsor-Europe
UMC Utrecht
Outcome results
None listed