Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers
NCT ID: NCT04461379
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
908 participants
INTERVENTIONAL
2020-07-21
2021-01-01
Brief Summary
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Detailed Description
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Age stratified randomization (\<45 years and\> 45 years) was performed using permuted blocks with allocation concealment.
The sample size is 908 patients. 454 patients in each stratum (227 with placebo and 227 with BCG vaccine).
Eligible participants will be healthcare professionals over 18 years of age who are in contact with patients with COVID-19, with negative IgG and IgM antibodies results for SARS-CoV-2 prior to their inclusion and sign the informed consent. After signing the informed consent, the participants will be randomized 1:1 to the intervention group (BCG vaccine) or control (placebo), a medical history will be performed, and a blood plasma sample will be obtained to determine specific antibodies against SARS-CoV-2.
The patients will be followed up for 6 months after the application of the vaccine, they will be contacted by phone every two weeks in order to identify the adverse effects of the vaccine (30 days after the application) as well as to identify symptoms of COVID-19, in addition, follow-up visits will be carried out at the third and sixth months, in each of these visits a blood plasma sample will be obtained and IgG and IgM antibodies will be measured.
Statistical Analysis Type: By intention to treatment
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Intervention: BCG vaccine intradermally 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis. (Tokio 172 strain). The application technique is based on the National Vaccination Manual version 2017.
Comparator: Placebo, intradermally 0.1 ml of NaCl 0.9%
PREVENTION
TRIPLE
Study Groups
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BCG Vaccine
A single dose BCG vaccine intradermally 0.1 ml.
BCG vaccine
A single dose BCG vaccine intradermally (deltoid region of the right arm) 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis . (Tokio 172 strain)
Placebo
A single dose intradermally 0.1 ml of NaCl 0.9% solution
Placebo
A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution
Interventions
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BCG vaccine
A single dose BCG vaccine intradermally (deltoid region of the right arm) 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis . (Tokio 172 strain)
Placebo
A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Negative specific IgG and IgM antibodies test result for SARS CoV-2 before the enrollment.
* Provide a signed and dated informed consent form
Exclusion Criteria
* Positive test for specific antibodies IgG and IgM antibodies result for SARS Cov-2
* Primary or secondary immunosuppression
* Use of immunosuppression drugs, use of hydroxychloroquine, cloroquine, Azithromycin, Lopinavir/ritonavir, Ivermectin or any other drug used to treat patients COVID-19 before the enrollment.
* Chemotherapy treatment
* Presence of antibodies IgA, IgM, IgG against SARS-CoV-2
* Pregnancy or breastfeeding
* Missing informed consent form
* Fever \> 38° in the previous 24 hours
* Any BCG vaccine contraindication
* History of previous allergy to the components of the vaccine
* Already part of any other trial
* Previous or active tuberculosis (TB) disease
* Another vaccine administrated 4 months before the start of the trial.
* Any underlying history of malignancy or lymphoma.
* Actual treatment with steroids
* Absence of more than 1 month from the hospital, from the study period.
18 Years
ALL
Yes
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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René Rodríguez-Gutiérrez
Professor Endocrinology Division, Facultad de Medicina
Locations
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Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico
Countries
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Related Links
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Other Identifiers
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EN20-00011
Identifier Type: -
Identifier Source: org_study_id