The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.
The aim of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers. The study will include a comparison between placebo and RUTI® vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
315
Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.
Physiological serum, 0.9% NaCl, will be used as a placebo
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals
Badalona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Documented cumulative incidence of SARS-CoV-2 infection
% positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Time frame: Up to 4 months
Sick leave for SARS-CoV-2
Number of days of documented sick leave for SARS-CoV-2
Time frame: Up to 4 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: Up to 4 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: Up to 4 months
Professional category
Number of MD, nursing, personnel management and services, etc.
Time frame: Up to 4 months
Fever
Number of days of self-reported fever (≥38 ºC)
Time frame: Up to 4 months
Incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: Up to 4 months
Days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
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Time frame: Up to 4 months
Incidence of pneumonia
Number of participants with pneumonia confirmed by X-ray
Time frame: Up to 4 months
Incidence of death from SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Time frame: Up to 4 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: Up to 4 months
Days in ICU
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of SARS-CoV-2 antibodies
Incidence of SARS-CoV-2 antibodies at the end of the study period
Time frame: Final visit
Types of antibodies detected
Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
Time frame: Final visit
Levels of SARS-CoV-2 antibodies
Levels of SARS-CoV-2 antibodies at the end of the study period
Time frame: Final visit