COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04659941

Not reported

Not reported

2020-12-09

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: 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) have not received a specific vaccine against covid-19 or, if vaccinated against sars-cov-2, have received the complete immunization schedule only with vaccines approved by anvisa and implemented by the national immunization program, (including the second dose) within a minimum of 15 days prior to the date of inclusion in the study if the participant have not received a specific vaccine against covid-19 approved by anvisa, be aware and agree to be able to receive them only 15 days after the intervention proposed in this study

professionals with a history of sars-cov-2 confirmed infection through rt-pcr or who have already presented clinical and molecular 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 (ºc) in the last 48h] participation in other prevention clinical trials for covid-19 (vaccines already approved by anvisa for use by the national immunization program are not included in this item) 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

2

Universidade Federal do Rio de Janeiro

18

100

Brazil

Healthy volunteers

N/A

752

Compare the cumulative incidence of severe forms of COVID-19;Assess the BCG vaccine-mediated immune response in health care workers;Compare the cumulative incidence of SARS-CoV-2 infection

None

Phase 2

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