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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 : Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2014 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo-controlled adaptive multi-centre randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
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
0.9% NaCl
Biological: Placebo
0.9% NaCl




Primary Outcome Measures :
  1. SARS-CoV-2 related hospital admission [ Time Frame: Maximum of 1 year ]

Secondary Outcome Measures :
  1. the duration of hospital admission due to documented COVID-19 [ Time Frame: Maximum of 1 year ]
  2. the cumulative incidence of documented SARS-CoV-2 infection [ Time Frame: Maximum of 1 year ]
  3. the cumulative incidence of self-reported acute respiratory symptoms or fever [ Time Frame: Maximum of 1 year ]
  4. the cumulative incidence of death due to documented SARS-CoV-2 infection [ Time Frame: 1 year ]
  5. the cumulative incidence of hospital admission for any reason [ Time Frame: Maximum of 1 year ]
  6. the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection [ Time Frame: Maximum of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Netherlands
Radboud University
Nijmegen, Gelderland, Netherlands, 6525 GA
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04417335    
Other Study ID Numbers: NL73430.091.20
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

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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
Keywords provided by Radboud University:
BCG
Bacille Calmette-Guérin
COVID-19
SARS-CoV-2
trained immunity
off-target effects
Additional relevant MeSH terms:
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BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs