Status:
UNKNOWN
Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
BCG
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths. Health workers are at high risk of COVID-19 infection. Their absence from work dramatically limits the ability ...
Detailed Description
The study design is a randomized, double-blinded, placebo-controlled clinical trial. Age stratified randomization (\<45 years and\> 45 years) was performed using permuted blocks with allocation conce...
Eligibility Criteria
Inclusion
- Health workers who are working onsite in patients' areas with COVID-19
- 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
- Age \<18 years
- 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.
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
908 Patients enrolled
Trial Details
Trial ID
NCT04461379
Start Date
July 21 2020
End Date
January 1 2021
Last Update
November 13 2020
Active Locations (1)
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1
Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico, 64460