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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2021-11-11

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.

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Detailed Description

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Conditions

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Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group RUTI

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.

Group Type EXPERIMENTAL

RUTI® vaccine

Intervention Type BIOLOGICAL

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.

Group Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Physiological serum, 0.9% NaCl, will be used as a placebo.

Interventions

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RUTI® vaccine

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.

Intervention Type BIOLOGICAL

Placebo

Physiological serum, 0.9% NaCl, will be used as a placebo.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Sign the Informed Consent before initiating the selection procedures.
2. Population:

1. Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2
2. People between 18 years and 59 years
3. Willingness to meet the requirements of the protocol.
4. Negative Rapid Serological Test of SARS-CoV-2
5. The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age.

Exclusion Criteria

1. Previous SARS-CoV-2 infection
2. Pregnancy. Pregnancy test will be performed in case of doubt.
3. Breastfeeding.
4. Suspected of active viral or bacterial infection.
5. Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
6. Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine.
7. 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.
8. 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.
9. Malignancy, or active solid or non-solid lymphoma from the previous two years.
10. Soy allergy.
11. Direct involvement in the design or execution of the RUTICOVID19 clinical trial.
12. 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.
13. Do not have a smartphone.
14. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes