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Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity

A Randomized, Double-blind, Placebo-controlled Phase 3 Study: Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 Infection Rate and COVID-19 Severity

NCT04439045•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Eighteen years of age or older
•Employee/member of: municipal or provincial police service, emergency medical services, fire services, public transport service, health service, food manufacturing facility

Exclusion Criteria

•Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood.
•Previous known history of latent or active tuberculosis
•Known kidney, liver or blood disorders which impairs organ and marrow function
•Chronic administration of steroids (\>10 mg prednisone) at the time of randomization
•Current or planned concomitant biologic therapy in the next 7 months.
•Known hypersensitivity or allergy to components of VPM1002
•Pregnant or planning to become pregnant in the future 7 months.
•Breastfeeding.
•Current suspected viral or bacterial infection.
•Body temperature \> 38° C
+8 more criteria

Locations (1)

University Health Network

Toronto, Ontario, Canada

Key Dates

Start Date

June 24, 2020

Primary Completion Date

September 9, 2021

Completion Date

September 9, 2021

Last Updated

April 15, 2022

Enrollment

122

ACTUAL participants

Conditions

SARS-CoV-2 Infection

Interventions

VPM1002

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity

Inclusion Criteria

Exclusion Criteria

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