The aim of this study is to explore potential for reduction of incidence and/or morbidity of SARS-CoV-2 infection in healthcare personnel. The study will include a comparison between placebo and RUTI® vaccine in a 2:1 design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
251
Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in a total volum of 0,3mL.
Physiological serum, 0.9% NaCl, will be used as a placebo.
Hospital General de Agudos Dr. Ignacio Pirovano
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital General
Mendoza, Argentina
Hospital José Néstor Lencinas
Mendoza, Argentina
Documented cumulative incidence of SARS-CoV-2 infection
Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Time frame: 6 months
Sick leave for SARS-CoV-2
Number of days of documented sick leave for SARS-CoV-2
Time frame: 6 months
Days off work due to the quarantine
The number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2
Time frame: 6 months
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Time frame: 6 months
Fever
Number of days of self-reported fever (≥38 ºC)
Time frame: 6 months
Incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: 6 months
Days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
Time frame: 6 months
Incidence of pneumonia
Presence of compatible symptoms and radiological or tomographic focal alteration in the context of a confirmed diagnosis of Covid-19 infection and without evidence of other concomitant pathologies
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
San Miguel de Tucumán, Argentina
Hospital Materno Infantil "Dr. Héctor Quintana"
San Salvador de Jujuy, Argentina
Time frame: 6 months
Incidence of death from SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of admissions to Intensive Care Unit (ICU)
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Time frame: 6 months
Days in ICU
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Time frame: 6 months
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of SARS-CoV-2 antibodies
Incidence of SARS-CoV-2 antibodies at the end of the study period
Time frame: Study completion, an average of 1 year
Types of antibodies detected
Frequency of immunoglobulin IgG and immunoglobulin IgM
Time frame: Study completion, an average of 1 year
Levels of SARS-CoV-2 antibodies
Levels of SARS-CoV-2 antibodies
Time frame: Study completion, an average of 1 year