SARS-CoV-2 InfectionPhase 3COBRANCT04439045
Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity
A Phase 3 study testing VPM1002 in people with SARS-CoV-2 Infection, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- VPM1002
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2020to 9 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- VPM1002, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPM1002Biological
Also called Mycobacterium bovis rBCGΔureC::hly
VPM1002 is a recombinant BCG (rBCG)
PlaceboOther
Also called sodium chloride
0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| VPM1002 | Experimental | 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. Receives: Biological: VPM1002 |
| Placebo | Placebo comparator | A single dose of 0.1 mL of the 0.9% sodium chloride injection, administered via intradermal injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 infection
To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.
Measured: 7 months
Secondary outcomes (7)
Incidence of hospitalization for COVID-19
To compare the incidence of hospitalization in participants with positive COVID-19 test treated with either VPM1002 or placebo
Measured: 7 months
Incidence of ICU admission for COVID-19
To compare the incidence of hospitalization requiring intensive care (ICU admission) in participants with positive COVID-19 test treated with either VPM1002 or placebo
Measured: 7 months
Incidence of ARDS
To compare the incidence of acute respiratory distress syndrome (ARDS) in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measured: 7 months
Mechanical ventilation for COVID-19
To compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measured: 7 months
Secondary infection in COVID-19
To compare the incidence of secondary infection in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measured: 7 months
COVID-19-related Mortality
To compare the mortality in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measured: 7 months
Incidence of DVT
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start24 Jun 2020
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Serum Institute of India Pvt. Ltd., Max Planck Institute for Infection Biology, Verity Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Alexandre R Zlotta, MD PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439045
- Sponsor's protocol ID
- 20-5413
- Acronym
- COBRA
- Status last verified
- Apr 2022
- First submitted
- 3 Jun 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
PubMed 38597249
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04439045
- Acronym / sponsor ID
- COBRA / 20-5413
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Serum Institute of India Pvt. Ltd., Max Planck Institute for Infection Biology, Verity Pharmaceuticals Inc.
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VPM1002 | Experimental | Biological: VPM1002A 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. |
| Placebo | Placebo comparator | Other: PlaceboA single dose of 0.1 mL of the 0.9% sodium chloride injection, administered via intradermal injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPM1002Also: Mycobacterium bovis rBCGΔureC::hlyVPM1002 is a recombinant BCG (rBCG) | Biological | VPM1002 |
| PlaceboAlso: sodium chloride0.9% sodium chloride | Other | Placebo |
Primary outcome
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.
7 secondary outcomes
Incidence of hospitalization for COVID-19
Time frame: 7 months
Incidence of ICU admission for COVID-19
Time frame: 7 months
Incidence of ARDS
Time frame: 7 months
Mechanical ventilation for COVID-19
Time frame: 7 months
Secondary infection in COVID-19
Time frame: 7 months
COVID-19-related Mortality
Time frame: 7 months
Incidence of DVT
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Derived from this study: PubMed 38597249Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre R Zlotta, MD PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VPM1002 in people with SARS-CoV-2 Infection, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 infection (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.