COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-5ysj54

Fernanda;Fernanda Mello;Mello

fcqmello@gmail.com

2020-07-27

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

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

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)

2

Universidade Federal do Rio de Janeiro

18

75

Brazil

Health workers

N/A

0

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

Phase 2/Phase 3

[{"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]