Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04417335|
Recruitment Status : Unknown
Verified May 2020 by Radboud University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||60 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
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|
|Responsible Party:||Radboud University Medical Center|
|Other Study ID Numbers:||
2020-001591-15 ( EudraCT Number )
|First Posted:||June 4, 2020 Key Record Dates|
|Last Update Posted:||June 4, 2020|
|Last Verified:||May 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Physiological Effects of Drugs