Exploratory Study to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

Study Overview
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Brief Summary
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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.

Official Title
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A Exploratory Phase II Clinical Trial, Double-blind, Randomized Placebo-controlled to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

Conditions
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Covid-19

Intervention / Treatment
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* Biological: RUTI® vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the Informed Consent before initiating the selection procedures. Population: Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2 People between 18 years and 59 years Willingness to meet the requirements of the protocol. Negative Rapid Serological Test of SARS-CoV-2 The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age. Exclusion Criteria: Previous SARS-CoV-2 infection Pregnancy. Pregnancy test will be performed in case of doubt. Breastfeeding. Suspected of active viral or bacterial infection. Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test. Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine. Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study. Severely immunocompromised people. This exclusion category includes: Subjects with human immunodeficiency virus (HIV-1). Neutropenic subjects with less than 500 neutrophils / mm3. Subjects with solid organ transplantation. Subjects with bone marrow transplantation. Subjects undergoing chemotherapy. Subjects with primary immunodeficiency. Severe lymphopenia with less than 400 lymphocytes / mm3. Malignancy, or active solid or non-solid lymphoma from the previous two years. Soy allergy. Direct involvement in the design or execution of the RUTICOVID19 clinical trial. Retirement, transfer, long-term leave (> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study. Do not have a smartphone. Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol. 16. Any other findings that, at the discretion of the researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group RUTI<br>Participants will receive two dose of RUTI® vaccine at the baseline visit and after 2 weeks +/- 3 days, which will be administered subcutaneously in the deltoid region at a dose of 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in an injection volume of 0.3 mL. | Biological: RUTI® vaccine<br>* 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.<br>|
| Placebo Comparator: Group Placebo<br>Participants will receive two dose of physiological serum will be administered subcutaneously in the deltoid region at the baseline visit and after 2 weeks +/- 3 days. | Biological: Placebo<br>* Physiological serum, 0.9% NaCl, will be used as a placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick leave for SARS-CoV-2 | Number of days of documented sick leave for SARS-CoV-2 | 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 | 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 | 6 months | 
| Fever | Number of days of self-reported fever (≥38 ºC) | 6 months | 
| Incidence of self-reported acute respiratory symptoms | Cumulative incidence of self-reported acute respiratory symptoms | 6 months | 
| Days of self-reported acute respiratory symptoms | Number of days of self-reported acute respiratory symptoms | 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 | 6 months | 
| Incidence of death from SARS-CoV-2 infection | Cumulative incidence of death from documented SARS-CoV-2 infection | 6 months | 
| Incidence of admissions to Intensive Care Unit (ICU) | Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection | 6 months | 
| Days in ICU | Number of days admitted to the ICU for documented SARS-CoV-2 infection | 6 months | 
| Incidence of mechanical ventilation | Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection | 6 months | 
| Incidence of hospital admissions | Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection | 6 months | 
| Days of hospitalization | Number of days of hospitalization for documented SARS-CoV-2 infection | 6 months | 
| Incidence of SARS-CoV-2 antibodies | Incidence of SARS-CoV-2 antibodies at the end of the study period | Study completion, an average of 1 year | 
| Types of antibodies detected | Frequency of immunoglobulin IgG and immunoglobulin IgM | Study completion, an average of 1 year | 
| Levels of SARS-CoV-2 antibodies | Levels of SARS-CoV-2 antibodies | Study completion, an average of 1 year |