Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- BCG
- Corona Virus Infection
- COVID-19
- SARS COV2
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A randomized double-blinded clinical trial, using computer software, participants will be allocated between two groups: 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%Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Participants, researchers (including members of the research team that will assess outcomes), and treating physicians or health personnel (should the patient require in-hospital management) will be blinded to the treatment group to which the patients were randomized. Only the personnel who apply the vaccine will not be blinded to the treatment group to which the patients were randomized (this personnel will not have any further contact with the patients or provide any other type of patient care).Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 concealment. The sample size is 908 patients. 454 patients in each stratum (227 with placebo and 227 with BC...
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 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
Tracking Information
- NCT #
- NCT04461379
- Collaborators
- Not Provided
- Investigators
- Not Provided
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