healthy volunteers working in the healthcare treating patients with new type of coronavirus (SARS-CoV-2) infection
Conditions
Interventions
Trade Name: SSI BCG powder and solvent for suspension for injection
Product Name: BCG vaccine (Danish strain 1331, SSI, Denmark)
Product Code: OGYI-T-9001/02
Pharmaceutical Form: Suspension for inject
Sponsors
National Korányi Institute of Pulmonology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: • Adult (>18 years) • Healthcare worker with direct contact with COVID-19 positive patients • Written informed consent 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 950 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Fever (>37,5 ºC) within the past 24 hours • Suspicion of current active viral or bacterial infection • Expected vaccination during the study period, independently 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 immunosuppressant drugs such as anti-cytokine therapies, and 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 • Active participation in another research study that involves BCG administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reduce absenteeism among healthcare workers with direct COVID-19 positive patient contacts during the epidemic phase of COVID-19. ;Secondary Objective: Secondary objectives: To reduce COVID-19 infection, hospital admission, ICU admission, or death in healthcare workers with direct COVID-19 positive patient contacts during the epidemic phase of COVID-19;Primary end point(s): Primary End Point (repeat as necessary) Number of days of unplanned absenteeism because of documented COVID-19 infection ;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): E.5.2 Secondary End Point (repeat as necessary) Secondary endpoints will be: the duration of hospital admission; the cumulative incidence of documented COVID-19 infection; the number of days of self-reported fever (=38 ºC); the cumulative incidence of self-reported acute respiratory symptoms; the number of days of self-reported acute respiratory symptoms; the number of days of self-reported diarrhoea due to COVID-19 infection; the cumulative incidence of diarrhoea due to COVID-19 infection; the cumulative incidence of death for any reason; the cumulative incidence of death due to documented COVID-19 infection; the cumulative incidence of hospital or Intensive Care Admission for any reason; the cumulative incidence of Intensive Care Admission due to documented COVID-19 infection.;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Hungary
Contacts
Public ContactDirectorate
National Korányi Institute of Pulmonology
Outcome results
None listed