COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04461379

René Rodríguez-Gutiérrez, Dr.MSc.

rodriguezgutierrez.rene@mayo.edu

2020-07-08

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - health workers who are working onsite in patients' areas with covid-19 - age > 18 years - negative specific igg and igm antibodies test result for sars cov-2 before the enrollment. - provide a signed and dated informed consent form

- age <18 years - positive test for specific antibodies igg and igm antibodies result for sars cov-2 - primary or secondary immunosuppression - use of immunosuppression drugs, use of hydroxychloroquine, cloroquine, azithromycin, lopinavir/ritonavir, ivermectin or any other drug used to treat patients covid-19 before the enrollment. - chemotherapy treatment - presence of antibodies iga, igm, igg against sars-cov-2 - pregnancy or breastfeeding - missing informed consent form - fever > 38° in the previous 24 hours - any bcg vaccine contraindication - history of previous allergy to the components of the vaccine - already part of any other trial - previous or active tuberculosis (tb) disease - another vaccine administrated 4 months before the start of the trial. - any underlying history of malignancy or lymphoma. - actual treatment with steroids - absence of more than 1 month from the hospital, from the study period.

2

Hospital Universitario Dr. Jose E. Gonzalez

18

100

Mexico

Health workers

N/A

908

Critical care admission with SARS-CoV2;Demonstrate COVID- 19 disease incidence among Health care workers:;Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers:;Demonstrate the Incidence of specific Antibodies against SARS-CoV-2 at 3 and 6 months in health care workers;Hospitalization of severe disease COVID-19;Oxygen supplementation in severe disease COVID-19;Mortality associated to progressive pulmonary disease;Need for intubation or non-invasive ventilation for the patient.

None

Phase 3

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