Healthy volunteers, health care workers. Immune system activation after BCG vaccination. Work absenteeism and COVID-19 will be monitored. MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Sponsors
University of Southern Denmark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult (=18 years); Hospital personnel working at one of the participating hospitals. 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 1400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration; Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species; Previous M. tuberculosis infection; Previous confirmed COVID-19 infection; Fever (>38 C) within the past 24 hours; Suspicion of active viral or bacterial infection; Pregnancy; Breastfeeding; Vaccination with other live attenuated vaccine within the last 4 weeks; Severely immunocompromised subjects. This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies. g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months; Active solid or non-solid malignancy or lymphoma within the prior two years; Direct involvement in the design or the execution of the BCG-DENMARK-COVID study; Employed to the hospital < 22 hours per week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reduce absenteeism among health care workers with direct patient contacts during the COVID-19 pandemic. ;Secondary Objective: To reduce the number of health care workers that are infected with SARS-CoV-2 during the COVID-19 pandemic and to reduce the number of hospital admissions amongst health care workers with direct patient contacts during the COVID-19 pandemic.;Primary end point(s): Number of days of unplanned absenteeism for any reason.;Timepoint(s) of evaluation of this end point: End of study as well as weekly interim analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The cumulative incidence of documented COVID-19. - The cumulative incidence of hospital admission for any reason. Furthermore, the following endpoints will be assessed: The number of days of unplanned absenteeism, because of documented SARS- CoV-2 infection; The number of days of absenteeism, because of imposed quarantine as a result of exposure to SARS-CoV-2; 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 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 death due to documented SARS- CoV-2 infection; The cumulative incidence of Intensive Care Admission for any reason; The cumulative incidence of Intensive Care Admission due to documented SARS- CoV-2 infection; The cumulative incidence of Hospital Admission due to documented SARS-CoV-2 infection. ;Timepoint(s) of evaluation of this end point: End of study as well as monthly interim analysis. | — |
Countries
Denmark
Contacts
Public ContactClinical Institute, OPEN
University of Southern Denmark
Outcome results
None listed