Reducing health care workers absenteeism in SARS-CoV-2 pandemic by enhanced trained immune responses through Bacillus Calmette-Guérin vaccination, a randomized controlled trial (COVID-19). - BCG-CORONA

niversity Medical Center0 sites1,000 target enrollmentMarch 17, 2020

DrugsBCG vaccine (BCG-Vaccin SSI [Nederlands VaccinStatens Serum Instituut]) Danish strain 1331.

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Medical Center
Enrollment: 1000
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 17, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Medical Center

Eligibility 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

•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
•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)