Use of BCG Vaccine as a Preventive Measure for COVID-19 in Health Care Workers

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    1000
  • sponsor
    Universidade Federal do Rio de Janeiro
Updated on 27 January 2021

Summary

The disease promoted by coronavirus (COVID-19) is caused by Severe Acute Respiratory Syndrome (SARS) caused by Coronavirus type 2 (CoV2), being the first cases identified in December 2019 in China after exposure to the animal market in Wuhan city, China. From the first case to the present day, the COVID-19 epidemic has been identified in 185 countries, with the notification of 2,666,154 cases and 186,144 deaths. In Brazil, more than 45,757 cases and 2,906 confirmed deaths by COVID-19 have been confirmed (Visualized on Apr 23 2020). In our country, to date, testing for COVID-19 occurs only in severe cases and few centers offer the service to health care workers, a population at high risk of infection. BCG is a vaccine produced from a live attenuated strain derived from a Mycobacterium bovis isolate and is widely used worldwide as a tuberculosis (TB) vaccine, but there are studies demonstrating non-specific immunotherapeutic mechanisms of this vaccine that signal a possible relationship with the lowest morbidity and mortality associated with COVID-19 infections worldwide. The present study aims to analyze the role of BCG in the prevention of SARS-CoV-2 infection and also in the occurrence of severe forms of COVID-19 in addition to evaluating the immune response mediated by this vaccine in voluntary health care workers.

Details
Condition COVID 19 Vaccine
Treatment BCG Vaccine
Clinical Study IdentifierNCT04659941
SponsorUniversidade Federal do Rio de Janeiro
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have COVID 19 Vaccine??
Individuals aged 18 , male or female, not infected with SARS-CoV-2
Agreement to participate in the study by signing the Free Informed Consent (FIC)
Not being pregnant (in case of women able to become pregnant)

Exclusion Criteria

Professionals with a history of infection confirmed by SARS-CoV-2 or who have already presented a diagnosis of COVID-19 prior to the study
Individuals who have not underwent confirmatory tests for COVID-19
Breastfeeding
Individuals with primary or acquired immunodeficiency
Individuals affected by malignant neoplasms
Patients treated with high-dose corticosteroids (equivalent to the prednisone dose of 20 mg/day or more) for more than two weeks
Patients using other immunosuppressive therapies (antineoplastic chemotherapy, radiotherapy, among others)
Individuals with autoimmune diseases
Dermatological conditions at the vaccine site or generalized
Individuals under treatment for active tuberculosis
Individuals with a history of previous tuberculosis treatment
Individuals with febrile symptoms [body temperature 37.5 celsius degree (C) in the last 48h]
Participation in other prevention clinical trials for COVID-19
Report of vaccination with live microorganism administered in the month prior to randomization
Require that, if another vaccination with live microorganism is required, it is administered in the month following randomisation (If the other live vaccine can be administered on the same day, this exclusion criterion does not apply)
Known anaphylactic reaction to any ingredient in BCG vaccine
Adverse reaction prior to BCG vaccine [significant local reaction (abscess) or suppurative lymphadenitis]
BCG vaccine administered in the last year
Clear my responses

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