COVID-19 Clinical Trial
Official title:
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
Verified date | May 2020 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also
been shown to induce protection against various infections with a viral aetiology, leading to
significant reductions in morbidity and mortality. We hypothesize that BCG vaccination might
be a potent preventive measure against SARS-CoV-2 infection and/or may reduce disease
severity in elderly people, who are known to be at increased risk of illness and death from
SARS-CoV-2 infection.
Therefore, we will in this placebo-controlled adaptive multi-centre randomized controlled
trial evaluate the ability of BCG to reduce hospital admission and its efficacy to improve
the clinical course of SARS-CoV-2 infection in elderly people((≥ 60 years of age).
Status | Active, not recruiting |
Enrollment | 2014 |
Est. completion date | May 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Adult (= 60 years) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University | Nijmegen | Gelderland |
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SARS-CoV-2 related hospital admission | Maximum of 1 year | ||
Secondary | the duration of hospital admission due to documented COVID-19 | Maximum of 1 year | ||
Secondary | the cumulative incidence of documented SARS-CoV-2 infection | Maximum of 1 year | ||
Secondary | the cumulative incidence of self-reported acute respiratory symptoms or fever | Maximum of 1 year | ||
Secondary | the cumulative incidence of death due to documented SARS-CoV-2 infection | 1 year | ||
Secondary | the cumulative incidence of hospital admission for any reason | Maximum of 1 year | ||
Secondary | the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection | Maximum of 1 year |
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