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.
ID
Bron
Verkorte titel
Aandoening
COVID-19
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• SARS-CoV-2 related hospital admission
Achtergrond van het onderzoek
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 and older age 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 respiratory infections, including those 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.
Objective: Primary objective: to reduce SARS-CoV-2-related hospital admission of community dwelling older persons (≥ 60 years of age). Secondary objective: to reduce the incidence of health symptoms, the duration of hospital admission, hospital or ICU admission for any reason, or death in community dwelling older persons during the SARS-CoV-2 outbreak.
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.
Main study parameters/endpoints: Primary endpoint: SARS-CoV-2 related hospital admission. Secondary endpoints: incidence of symptoms of infectious disease, hospital admission for any reason, duration of hospital admission, SARS-CoV-2 infection, Intensive Care admission, and death.
Doel van het onderzoek
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.
Onderzoeksopzet
6 months
Onderzoeksproduct en/of interventie
BCG-vaccine
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Adult (≥ 60 years)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8547 |
| CCMO | NL73430.091.20 |
| OMON | NL-OMON49238 |