SARS-CoV-2 infection MedDRA version: 20.0 Level: HLT Classification code 10047490 Term: Virus identification and serology System Organ Class: 100000004848
Conditions
Sponsors
University Medical Center
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) • Male or female • Hospital personnel (expected to) taking care for patients with SARS-CoV-2 infection 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 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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 |
|---|---|
| Main Objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of SARS-CoV-2.;Secondary Objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of SARS-CoV-2.;Primary end point(s): Number of days of unplanned absenteeism for any reason ;Timepoint(s) of evaluation of this end point: Between day 0 up to day 180 after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • the cumulative incidence of documented SARS-CoV-2 infection • 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 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 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 for any reason • the cumulative incidence of Hospital Admission due to documented SARS-CoV-2 infection • the incidence and magnitude of SARS-CoV-2 antibodies at the end of the study period;Timepoint(s) of evaluation of this end point: Between day 0 up to day 180 after inclusion | — |
Countries
Netherlands
Contacts
Public ContactMarc J. M. Bonten
University Medical Center Utrecht
Outcome results
None listed