REDUCING HOSPITAL ADMISSION OF ELDERLY IN SARS-CoV-2 PANDEMIC VIA THE INDUCTION OF TRAINED IMMUNITY BY BACILLUS CALMETTE-GUÉRIN VACCINATION, A RANDOMIZED CONTROLLED TRIA
- Conditions
- COVID-19
- Registration Number
- NL-OMON19909
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1600
•Adult (= 60 years)
•Fever (>38 ºC) within the past 24 hours
•Suspicion of current active viral or bacterial infection
•Expected vaccination during the first three months of the study period
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •SARS-CoV-2 related hospital admission
- Secondary Outcome Measures
Name Time Method •the duration of hospital admission<br>•the cumulative incidence of documented SARS-CoV-2 infection <br>•the number of days of self-reported fever (=38 ºC)<br>•the number of days of self-reported acute respiratory symptoms <br>•the cumulative incidence of self-reported acute respiratory symptoms<br>•the cumulative incidence of delirium due to SARS-CoV-2<br>•the cumulative incidence of pneumonia, skin infection, urinary tract infection, flu and gastro-intestinal infection<br>•the cumulative incidence of death for any reason<br>•the cumulative incidence of death due to documented SARS-CoV-2 infection<br>•the cumulative incidence of hospital or Intensive Care Admission for any reason<br>•the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection<br>