Clinical trial NCT04439045: Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Serum Institute of India Pvt. Ltd.
name: Max Planck Institute for Infection Biology
name: Verity Pharmaceuticals Inc.
First posted: 2020-06-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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 criteria: 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
* 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.

Primary outcomes:
measure: COVID-19 infection
timeFrame: 7 months
Secondary outcomes:
measure: Incidence of hospitalization for COVID-19
timeFrame: 7 months
measure: Incidence of ICU admission for COVID-19
timeFrame: 7 months
measure: Incidence of ARDS
timeFrame: 7 months
measure: Mechanical ventilation for COVID-19
timeFrame: 7 months
measure: Secondary infection in COVID-19
timeFrame: 7 months
measure: COVID-19-related Mortality
timeFrame: 7 months
measure: Incidence of DVT
timeFrame: 7 months
Other outcomes:
measure: Incidence of COVID-19 in Participants with Past BCG Vaccination
timeFrame: 7 months
measure: Measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin as biomarkers of COVID-19
timeFrame: 7 months
measure: Adverse events following BCG vaccine
timeFrame: 7 months
measure: Innate Trained Immunity
timeFrame: 7 months
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Alexandre R Zlotta, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: