Coronavirus infection unespecific localization
Conditions
Interventions
Experimental group: 500 heathcare workers will be vaccinated with BCG vaccine and will have a follow-up for the next 6 months in 2 moments or when necessary
Control group:500 heathcare workers will be
Biological/vaccine
Sponsors
Universidade Federal do Rio de Janeiro
Universidade do Estado do Rio de Janeiro
Eligibility
Inclusion criteria
Inclusion criteria: Individuals aged above 18 years old, male or female, not infected with SARS-CoV-2 who exercise professional activities in the Health Units of the study; Agreement to participate in the study by signing the informed consent form
Exclusion criteria
Exclusion criteria: Professionals with a history of infection confirmed by SARS-CoV-2 or who have already been diagnosed with COVID-19 prior to the study; Individuals who have not performed confirmatory tests for COVID-19; Pregnancy or breast-feeding; Non-permanence in activities in the Health Units after 6 months of enrollment in the study; Individuals with primary or acquired immunodeficiency; Individuals with malignant neoplasms; Patients on high-dose corticosteroids (equivalent to a prednisone dose of 20 mg / day or more) for more than two weeks; Patients using other immunosuppressive therapies (antineoplastic chemotherapy, radiation therapy, among others); Individuals with autoimmune diseases; Dermatological disorders at the vaccine site or generalized; Individuals under treatment for active tuberculosis; Individuals with report of fever (axillary temperature> 38 ° C in the last 48h)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a smaller number of coronavirus infections in the BCG vaccinated group when compared to those vaccinated with placebo;It is expected to find a smaller number of severe coronavirus infections in the BCG vaccinated group when compared to those vaccinated with placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the immune response mediated by the BCG vaccine in healthcare professionals | — |
Countries
Brazil
Contacts
Public ContactFernanda;Fernanda Mello;Mello
UNiversidade Federal do Rio de Janeiro;Universidade Federal do Rio de Janeiro
Outcome results
None listed