Trials / Completed
CompletedNCT04327206
BCG Vaccination to Protect Healthcare Workers Against COVID-19
BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6,828 (actual)
- Sponsor
- Murdoch Childrens Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.
Detailed description
Healthcare workers are at the frontline of the coronavirus disease (COVID-19) pandemic. They will be randomised to receive a single dose of BCG vaccine or 0.9% NaCl placebo. Participants will be followed-up for 12 months with notification from a Smartphone application or phone calls (up to daily when ill) and surveys to identify and detail COVID-19 infection. Additional information on severe disease will be obtained from hospital medical records and/or government databases. Blood samples will be collected prior to randomisation and at 3, 6, 9 and 12 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection. The trial includes a pre-planned meta-analysis with data from 2834 participants recruited in the Stage 1 of this study, where participants were randomised to receive BCG or no BCG vaccine at the time of receiving influenza vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCG Vaccine | Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331. Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection |
| DRUG | 0.9%NaCl | 0.9% Sodium Chloride Injection |
Timeline
- Start date
- 2020-03-30
- Primary completion
- 2021-11-10
- Completion
- 2022-05-27
- First posted
- 2020-03-31
- Last updated
- 2024-09-19
Locations
36 sites across 5 countries: Australia, Brazil, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04327206. Inclusion in this directory is not an endorsement.