Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04439045
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Collaborators:
Serum Institute of India Pvt. Ltd.
Max Planck Institute for Infection Biology
Verity Pharmaceuticals
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 19, 2020
Last Update Posted Date June 19, 2020
Estimated Study Start Date  ICMJE June 14, 2020
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Incidence of hospitalization for COVID-19 [ Time Frame: 7 months ]
    To compare the incidence of hospitalization in participants with self-reported positive COVID-19 test, subsequently confirmed by review of medical records.
  • 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 self-reported positive COVID-19 test, subsequently confirmed by review of medical records.
  • Incidence of ARDS [ Time Frame: 7 months ]
    Incidence of acute respiratory distress syndrome (ARDS) in participants with positive COVID-19 test treated with either VPM1002 or placebo.
  • Mechanical ventilation for COVID-19 [ Time Frame: 7 months ]
    Compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo. Confirmed by review of medical records
  • 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.
  • 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.
  • Innate Trained Immunity [ Time Frame: 7 months ]
    To evaluate the ability of the VPM1002 vaccine to prime an innate trained immunity (i.e. inducing Th1 and Th17 responses to unrelated stimuli) compared to participants administered placebo.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 18, 2020)
  • Incidence of COVID-19 in Participants with Past BCG Vaccination [ Time Frame: 7 months ]
    Compare the incidence of COVID-19 in participants who have received BCG vaccination previously.
  • 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.
  • Adverse events following BCG vaccine [ Time Frame: 7 months ]
    Adverse events following administration of VPM1002 when used for prevention of COVID-19.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity
Official Title  ICMJE 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
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 police officers 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 of the police forces in Ontario.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
The clinical trial is designed as a double-blind (observer blind) study. Observer-blind means that during the course of trial, the companions/parents/guardians of the subjects and the study personnel responsible for the evaluation of any study endpoint will be unaware which vaccine was administered.
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2 Infection
Intervention  ICMJE
  • Biological: VPM1002
    VPM1002 is a recombinant BCG (rBCG)
    Other Name: Mycobacterium bovis rBCGΔureC::hly
  • Other: Placebo
    0.9% sodium chloride
    Other Name: sodium chloride
Study Arms  ICMJE
  • Experimental: VPM1002
    A single dose of 0.1 mL of the reconstituted vaccine containing VPM1002 (Mycobacterium bovis rBCGΔureC::hly, live 2-8 × 105 CFU), administered via intradermal injection.
    Intervention: Biological: VPM1002
  • Placebo Comparator: Placebo
    A single dose of 0.1 mL of the 0.9% sodium chloride injection, administered via intradermal injection.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2020)
3626
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eighteen years of age or older
  • Front-line employee of provincial or municipal police force
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood.
  • Previous known history of latent or active tuberculosis
  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cynthia Kuk, MSc 416-586-4800 ext 3910 cynthia.kuk@sinaihealth.ca
Contact: Miran Kenk, PhD miran.kenk@uhn.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04439045
Other Study ID Numbers  ICMJE 20-5413
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE
  • Serum Institute of India Pvt. Ltd.
  • Max Planck Institute for Infection Biology
  • Verity Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Alexandre R Zlotta, MD PhD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP