SARS-CoV-2, COVID19
Conditions
Interventions
Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio
Sponsors
University Medical Centre Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: - Adult (=18 years); - Male or female; - Hospital personnel (expected to) taking care for patients with SARS-CoV-2 infection
Exclusion criteria
Exclusion criteria: - Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration; - Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection; - Fever (>38 C) within the past 24 hours - Pregnancy; - Suspicion of active viral or bacterial infection; - Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination - Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks; - Active solid or non-solid malignancy or lymphoma within the prior two years; - Direct involvement in the design or the execution of the BCG-CORONA study; - Expected absence from work of =4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc); - Employed to the hospital < 22 hours per week; - Not in possession of a smartphone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days of unplanned absenteeism for any reason | — |
Secondary
| Measure | Time frame |
|---|---|
| -Secondary endpoints will be: • the cumulative incidence of documented COVID-19 infection • the cumulative incidence of Hospital Admission due to documented COVID-19 infection • the number of days of unplanned absenteeism, because of documented COVID-19 infection • the cumulative incidence of self-reported acute respiratory symptoms or fever • the cumulative incidence of death due to documented COVID-19 infection • the cumulative incidence of Intensive Care Admission due to documented COVID-19 infection Exploratory endpoints will be: • the number of days of absenteeism, because of imposed quarantine as a result of exposure to SARS-CoV-2 infection • the number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented SARS-CoV-2 infection • the number of days of unplanned absenteeism because of self-reported acute respiratory symptoms • the number of days of self-reported fever (=38 gr C) • the cumulative incidence of self-reported fever (=38 gr C) • the number of days of self-reported acute respiratory symptoms • the cumulative incidence of self-reported acute respiratory symptoms • the cumulative incidence of death for any reason • the cumulative incidence of Intensive Care Admission for any reason • the cumulative incidence of Hospital Admission for any reason • the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period • the cumulative incidence and magnitude of total and/or SARS-COV-2-specific mucosal antibodies at 12 weeks after vaccination and at the end of the study period | — |
Contacts
Public ContactThomas van der Vaart
UMC Utrecht
Outcome results
None listed