Reducing hospital admission of elderly in SARS-CoV-2 pandemic via the induction of trained immunity by bacillus Calmette-Guérin vaccination, a randomized controlled trial.
- Conditions
- coronavirusSARS-CoV-2/COVID-1910047438
- Registration Number
- NL-OMON49238
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2000
In order to be eligible to participate in this study, a subject must meet the
following criteria:
• Adult (>= 60 years)
• Written informed consent
• Fever (>38 ºC) within the past 24 hours
• Suspicion of current active viral or bacterial infection
- Vaccination within 3 months of start studyperiod
• 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 <p>Primary endpoint: clinically relevant respiratory tract infections (including<br /><br>COVID-19 hospitalisation)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be:<br /><br><br /><br>• the duration of hospital admission<br /><br>• the cumulative incidence of documented SARS-CoV-2 infection<br /><br>• the number of days of self-reported fever (>=38 ºC)<br /><br>• the number of days of self-reported acute respiratory symptoms<br /><br>• the cumulative incidence of self-reported acute respiratory symptoms<br /><br>• the cumulative incidence of death for any reason<br /><br>• the cumulative incidence of death due to documented SARS-CoV-2 infection<br /><br>• the cumulative incidence of Intensive Care Admission for any reason<br /><br>• the cumulative incidence of Intensive Care Admission due to documented<br /><br>SARS-CoV-2 infection<br /><br>• the cumulative incidence of hospital admission due to documented SARS-CoV-2<br /><br>infection</p><br>