AzTrials
AzTrials

COVID-19Phase 4NCT04417335

Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination

A Phase 4 study testing BCG vaccine in people with COVID-19, run by Radboud University Medical Center at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
BCG vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,014 participants
Where
2 sitesNetherlands
Study dates
16 Apr 2020to May 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult (≥ 60 years)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Radboud University

    Nijmegen, Gelderland, 6525 GA

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

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

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).

Read the 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.

Conditions
COVID-19
Being tested
BCG vaccine, Placebo
Keywords
BCG, Bacille Calmette-Guérin, COVID-19, SARS-CoV-2, trained immunity, off-target effects
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCG vaccineBiological

    Bacille Calmette-Guérin is a live attenuated strain of Mycobacterium bovis developed in 1921 to prevent tuberculosis and other mycobacterial related infections.

  • PlaceboBiological

    0.9% NaCl

Study groups in NCT04417335
Study groupRoleWhat they receive
TreatmentExperimentalBCG vaccine (Danish strain 1331, SSI, Denmark)
Receives: Biological: BCG vaccine
PlaceboPlacebo comparator0.9% NaCl
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SARS-CoV-2 related hospital admission

    Measured: Maximum of 1 year

Secondary outcomes (6)

  1. the duration of hospital admission due to documented COVID-19

    Measured: Maximum of 1 year

  2. the cumulative incidence of documented SARS-CoV-2 infection

    Measured: Maximum of 1 year

  3. the cumulative incidence of self-reported acute respiratory symptoms or fever

    Measured: Maximum of 1 year

  4. the cumulative incidence of death due to documented SARS-CoV-2 infection

    Measured: 1 year

  5. the cumulative incidence of hospital admission for any reason

    Measured: Maximum of 1 year

  6. the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection

    Measured: Maximum of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start16 Apr 2020
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
placebo-controlled adaptive multi-centre randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
2,014 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417335
Sponsor's protocol ID
NL73430.091.20
Other IDs
2020-001591-15
Status last verified
May 2020
First submitted
25 May 2020
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fohse K, Taks EJM, Moorlag SJCFM, Bonten MJM, van Crevel R, Ten Oever J, van Werkhoven CH, Netea MG, van de Maat JS, Hoogerwerf JJ. The impact of circadian rhythm on Bacillus Calmette-Guerin vaccination effects on SARS-CoV-2 infections. Front Immunol. 2023 Feb 16;14:980711. doi: 10.3389/fimmu.2023.980711. eCollection 2023.

    PubMed 36875134

  • Moorlag SJCFM, Taks E, Ten Doesschate T, van der Vaart TW, Janssen AB, Muller L, Ostermann P, Dijkstra H, Lemmers H, Simonetti E, Mazur M, Schaal H, Ter Heine R, van de Veerdonk FL, Bleeker-Rovers CP, van Crevel R, Ten Oever J, de Jonge MI, Bonten MJ, van Werkhoven CH, Netea MG. Efficacy of BCG Vaccination Against Respiratory Tract Infections in Older Adults During the Coronavirus Disease 2019 Pandemic. Clin Infect Dis. 2022 Aug 24;75(1):e938-e946. doi: 10.1093/cid/ciac182.

    PubMed 35247264

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BCG vaccine in people with COVID-19, run by Radboud University Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 related hospital admission (time frame: Maximum of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417335, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in