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

CompletadoFase 2ClinicalTrials.gov

ID: NCT04903184Tipo: INTERVENTIONALInicio: 6 de ene de 2021Fin estimado: 11 de nov de 2021

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.
\. 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.

Intervenciones

biological

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.

biological

Placebo

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

Ubicaciones

Hospital de Clínicas Presidente Dr. Nicolás Avellaneda

San Miguel de Tucumán, Argentina

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

Hospital Materno Infantil "Dr. Héctor Quintana"

San Salvador de Jujuy, Argentina

Patrocinadores

PrincipalRUTI Immunotherapeutics S.L.

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