Status:
COMPLETED
Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Serum Institute of India Pvt. Ltd.
Max Planck Institute for Infection Biology
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- Participation in another interventional study with potentially conflicting medication within 30 days before screening.
- The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-TNF therapy, methotrexate, azathioprine, antimalarials).
- Active malignancy requiring treatment.
- Known positive HIV serology.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.
- Previous positive COVID-19 confirmed infection.
- Uncontrolled intercurrent illness.
- Psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04439045
Start Date
June 24 2020
End Date
September 9 2021
Last Update
April 15 2022
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2M9