Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination
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|ClinicalTrials.gov Identifier: NCT04417335|
Recruitment Status : Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: BCG vaccine Biological: Placebo||Phase 4|
On March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. The number of confirmed cases continues to rise, leading to significant morbidity and mortality worldwide. Although individuals of any age can acquire SARS-CoV-2, adults of middle age and older are most commonly affected. Moreover, recent reports demonstrate that mortality rates rise significantly among patients 60 years and older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences in elderly are desperately needed. 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 may reduce hospital admission and improve the clinical course of symptoms of elderly people during the SARS-CoV-2 outbreak. Primary objective: To reduce hospital admission of community dwelling older persons during the pandemic of SARS-CoV-2. Secondary objective: To reduce disease severity, the duration of hospital admission, ICU admission, or death in elderly during the pandemic of SARS-CoV-2.
Study design: A placebo-controlled adaptive multi-centre randomized controlled trial.
Study population: Elderly people (≥ 60 years of age). Intervention: Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2014 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||placebo-controlled adaptive multi-centre randomized controlled 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|
|Actual Study Start Date :||April 16, 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
BCG vaccine (Danish strain 1331, SSI, Denmark)
Biological: BCG vaccine
Bacille Calmette-Guérin is a live attenuated strain of Mycobacterium bovis developed in 1921 to prevent tuberculosis and other mycobacterial related infections.
Placebo Comparator: Placebo
- SARS-CoV-2 related hospital admission [ Time Frame: Maximum of 1 year ]
- the duration of hospital admission due to documented COVID-19 [ Time Frame: Maximum of 1 year ]
- the cumulative incidence of documented SARS-CoV-2 infection [ Time Frame: Maximum of 1 year ]
- the cumulative incidence of self-reported acute respiratory symptoms or fever [ Time Frame: Maximum of 1 year ]
- the cumulative incidence of death due to documented SARS-CoV-2 infection [ Time Frame: 1 year ]
- the cumulative incidence of hospital admission for any reason [ Time Frame: Maximum of 1 year ]
- the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection [ Time Frame: Maximum of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417335
|Nijmegen, Gelderland, Netherlands, 6525 GA|
|Utrecht, Netherlands, 3584 CX|