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Trial - NCT04439045


Column Value
Trial registration number NCT04439045
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04439045

First author
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Alexandre R Zlotta, MD PhD

Contact
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Cynthia Kuk, cynthia.kuk@sinaihealth.ca (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-06-19

Recruitment status
Last imported at : April 19, 2022, midnight
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University Health Network, Toronto

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

122

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

COVID-19 infection

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 1378, "treatment_name": "Vpm1002", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]