NCT04373291

Using BCG Vaccine to Protect Health Care Workers in the COVID-19 Pandemic

Completed Phase 3 Last updated 8 October 2021

What this trial tests

Phase 3 trial testing BCG-Denmark in COVID-19 in 1,293 participants. Completed in 1 October 2021.

Timeline

18 May 2020

Primary endpoint
31 July 2021

1 October 2021

Quick facts

Lead sponsor	Bandim Health Project
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,293
Start date	18 May 2020
Primary completion	31 July 2021
Estimated completion	1 October 2021
Sites	1 location across Denmark

Drugs / interventions tested

• BCG-Denmark — full drug profile →
• Saline

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Non-specific Effects of Vaccines — all drugs for Non-specific Effects of Vaccines →
• Morbidity — all drugs for Morbidity →
• Absenteeism — all drugs for Absenteeism →

Sponsor

Bandim Health Project — full company profile →

Who can join

Adults 18 to 100, any sex, with COVID-19 or Non-specific Effects of Vaccines. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The COVID-19 pandemic challenges the available hospital capacity, and this will be augmented by absenteeism of healthcare workers (HCW). HCW are at high risk, currently HCW constitute 20% of all the COVID-19 cases in Denmark. Strategies to prevent absenteeism of HCW are urgently needed.

Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other infections; significant reductions in morbidity and mortality have been reported, and a plausible immunological mechanism has been identified.

We hypothesize that BCG vaccination can reduce HCW absenteeism during the COVID-19 pandemic.

Primary objective: To reduce absenteeism among HCW with direct patient contacts during the COVID-19 epidemic. Secondary objective: To reduce the number of HCW that are infected with SARS-CoV-2 during the COVID-19 epidemic and to reduce the number of hospital admissions amongst HCW with direct patient contacts during the COVID-19 epidemic.

Study design: A multi-center randomized placebo controlled trial. Study population: 1500 HCW with direct patient contacts; defined as nurses, physicians and other medical staff working at emergency rooms and wards where COVID-infected patients are treated.

Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline).

Main study parameters/endpoints: Primary endpoint: Number of days of (unplanned) absenteeism for any reason. Secondary endpoints: Number of days of (unplanned) absenteeism because of documented COVID infection. Cumulative incidence of hospital admissions.

Risk for participants and impact: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The objective of this trial is to evaluate the potential beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of COVID infection.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Coronavirus vaccine development: from SARS and MERS to COVID-19.
   Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2
2. The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies.
   Frederiksen LSF, Zhang Y, Foged C, Thakur A. · · 2020 · cited 164× · PMID 32793245 · DOI 10.3389/fimmu.2020.01817
3. 100 years of Bacillus Calmette-Guérin immunotherapy: from cattle to COVID-19.
   Lobo N, Brooks NA, Zlotta AR, Cirillo JD, et al · · 2021 · cited 114× · PMID 34131332 · DOI 10.1038/s41585-021-00481-1
4. Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines.
   Flanagan KL, Best E, Crawford NW, Giles M, et al · · 2020 · cited 64× · PMID 33123165 · DOI 10.3389/fimmu.2020.579250
5. Immunobiology and immunotherapy of COVID-19: A clinically updated overview.
   Esmaeilzadeh A, Elahi R. · · 2021 · cited 59× · PMID 33022076 · DOI 10.1002/jcp.30076
6. Protection against SARS-CoV-2 by BCG vaccination is not supported by epidemiological analyses.
   Hensel J, McAndrews KM, McGrail DJ, Dowlatshahi DP, et al · · 2020 · cited 57× · PMID 33110184 · DOI 10.1038/s41598-020-75491-x
7. The BCG Vaccine for COVID-19: First Verdict and Future Directions.
   Gonzalez-Perez M, Sanchez-Tarjuelo R, Shor B, Nistal-Villan E, et al · · 2021 · cited 50× · PMID 33763077 · DOI 10.3389/fimmu.2021.632478
8. The 2020 Pandemic: Current SARS-CoV-2 Vaccine Development.
   Alturki SO, Alturki SO, Connors J, Cusimano G, et al · · 2020 · cited 49× · PMID 32973779 · DOI 10.3389/fimmu.2020.01880