CompletedPhase 3

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

Denmark1,293 participantsStarted 2020-05-18

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: * Adult (≥18 years); * Hospital personnel caring for patients with COVID-19. Exclusion Criteria: * Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration * Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species * Previous M. tuberculosis infection * Previous confirmed COVID-19 infection * Fever (\>38 C) within the past 24 hours * Suspicion of active viral or bacterial infection * Pregnancy * Severely immunocompromised subjects (This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies. g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months) * Active solid or non-solid malignancy or lymphoma within the prior two years; * Direct involvement in the design or the execution of the BCG-DENMARK-COVID study * Employed to the hospital \< 22 hours per week * Not in possession of a smartphone/tablet.

What they're measuring

Number of days of unplanned absenteeism for any reason

Timeframe: 6 months

Trial details

NCT IDNCT04373291

SponsorBandim Health Project

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-31