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.

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. - BCG-CORONA-ELDERLY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49238

Enrollment

2000

Registered

2020-04-06

Start date

2020-04-16

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronavirus SARS-CoV-2/COVID-19

Interventions

Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: • Adult (>= 60 years) • Written informed consent

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Primary endpoint: clinically relevant respiratory tract infections (including COVID-19 hospitalisation)	—

Secondary

Measure	Time frame
Secondary endpoints will be: • the duration of hospital admission • the cumulative incidence of documented SARS-CoV-2 infection • the number of days of self-reported fever (>=38 ºC) • 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 due to documented SARS-CoV-2 infection	—

Measure

Time frame

Secondary endpoints will be: • the duration of hospital admission • the cumulative incidence of documented SARS-CoV-2 infection • the number of days of self-reported fever (>=38 ºC) • 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 due to documented SARS-CoV-2 infection

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)