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OpenTrials
Completed

NCT Number: NCT04439045

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

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.

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VPM1002

Biological

VPM1002 is a recombinant BCG (rBCG)

Other names: Mycobacterium bovis rBCGΔureC::hly

Placebo

Other

0.9% sodium chloride

Other names: sodium chloride

Primary outcomes

  1. COVID-19 infection

    Time frame: 7 months

    To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.

Secondary outcomes

  1. Incidence of hospitalization for COVID-19

    Time frame: 7 months

    To compare the incidence of hospitalization in participants with positive COVID-19 test treated with either VPM1002 or placebo

  2. Incidence of ICU admission for COVID-19

    Time frame: 7 months

    To compare the incidence of hospitalization requiring intensive care (ICU admission) in participants with positive COVID-19 test treated with either VPM1002 or placebo

  3. Incidence of ARDS

    Time frame: 7 months

    To compare the incidence of acute respiratory distress syndrome (ARDS) in participants with positive COVID-19 test treated with either VPM1002 or placebo.

  4. Mechanical ventilation for COVID-19

    Time frame: 7 months

    To compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo.

  5. Secondary infection in COVID-19

    Time frame: 7 months

    To compare the incidence of secondary infection in participants with positive COVID-19 test treated with either VPM1002 or placebo.

  6. COVID-19-related Mortality

    Time frame: 7 months

    To compare the mortality in participants with positive COVID-19 test treated with either VPM1002 or placebo.

  7. Incidence of DVT

    Time frame: 7 months

    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.

Other outcomes

  1. Incidence of COVID-19 in Participants with Past BCG Vaccination

    Time frame: 7 months

    To compare the incidence of COVID-19 in participants who have received BCG vaccination previously vs those not previously vaccinated

  2. 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

    Time frame: 7 months

    To measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin identified as potential biomarkers of COVID-19 infection using blood samples collected prior to the vaccination and at the end of the 7-month follow-up.

  3. Adverse events following BCG vaccine

    Time frame: 7 months

    To compare adverse event profile in participants following administration of VPM1002 or placebo when used for prevention of COVID-19.

  4. Innate Trained Immunity

    Time frame: 7 months

    Compare the priming of the innate trained immunity (i.e. induction of Th1 and Th17 responses to unrelated stimuli) in participants following administration of VPM1002 or placebo when used for prevention of COVID-19.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Max Planck Institute for Infection Biology
  • Serum Institute of India Pvt. Ltd.
  • Verity Pharmaceuticals Inc.

Registry information

Official study 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

Acronym: COBRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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