NCT04417335

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,014

participants targeted

Target at P75+ for phase_4 covid19

Timeline
Completed

Started Apr 2020

Typical duration for phase_4 covid19

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 25, 2020

Last Update Submit

June 3, 2020

Conditions

COVID-19

Keywords

BCGBacille Calmette-GuérinCOVID-19SARS-CoV-2trained immunityoff-target effects

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 related hospital admission

    Maximum of 1 year

Secondary Outcomes (6)

  • the duration of hospital admission due to documented COVID-19

    Maximum of 1 year

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

    Maximum of 1 year

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

    Maximum of 1 year

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

    1 year

  • the cumulative incidence of hospital admission for any reason

    Maximum of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

BCG vaccine (Danish strain 1331, SSI, Denmark)

Biological: BCG vaccine

Placebo

PLACEBO COMPARATOR

0.9% NaCl

Biological: Placebo

Interventions

BCG vaccineBIOLOGICAL

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

Treatment
PlaceboBIOLOGICAL

0.9% NaCl

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥ 60 years)

You may not qualify if:

  • 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
  • Active solid or non-solid malignancy or lymphoma within the prior two years
  • Active participation in another research study that involves BCG administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 36875134DERIVED

  • 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.

    PMID: 35247264DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: placebo-controlled adaptive multi-centre randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 4, 2020

Study Start

April 16, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)