Bacille Calmette-Guerin (BCG) is a live attenuated vaccine administered for prevention of tuberculosis. Recently, several groups have hypothesized that BCG may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for COVID-19. Trials are currently being conducted in Australia, Netherlands, Germany and the United Kingdom to evaluate its effectiveness. Front line workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. They are at high risk of infection from COVID-19, with potentially high infection rate. The investigators propose an interventional trial to evaluate the effectiveness of BCG vaccination to prevent COVID-19 infection and reduce its severity in front-line employees in Ontario.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
122
VPM1002 is a recombinant BCG (rBCG)
0.9% sodium chloride
University Health Network
Toronto, Ontario, Canada
COVID-19 infection
To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.
Time frame: 7 months
Incidence of hospitalization for COVID-19
To compare the incidence of hospitalization in participants with positive COVID-19 test treated with either VPM1002 or placebo
Time frame: 7 months
Incidence of ICU admission for COVID-19
To compare the incidence of hospitalization requiring intensive care (ICU admission) in participants with positive COVID-19 test treated with either VPM1002 or placebo
Time frame: 7 months
Incidence of ARDS
To compare the incidence of acute respiratory distress syndrome (ARDS) in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Time frame: 7 months
Mechanical ventilation for COVID-19
To compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Time frame: 7 months
Secondary infection in COVID-19
To compare the incidence of secondary infection in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Time frame: 7 months
COVID-19-related Mortality
To compare the mortality in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Time frame: 7 months
Incidence of DVT
To compare the incidence of deep vein thrombosis, pulmonary embolism, or stroke in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Time frame: 7 months
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