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Completed

NCT Number: NCT04903184

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

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital General de Agudos Dr. Ignacio Pirovano, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

RUTI® Vaccine

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.

Placebo

Biological

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

Primary outcomes

  1. Documented cumulative incidence of SARS-CoV-2 infection

    Time frame: 6 months

    Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice

Secondary outcomes

  1. Sick leave for SARS-CoV-2

    Time frame: 6 months

    Number of days of documented sick leave for SARS-CoV-2

  2. Days off work due to the quarantine

    Time frame: 6 months

    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

  3. Quarantine imposed by close contact outside the center with SARS-CoV-2 positive

    Time frame: 6 months

    Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive

  4. Fever

    Time frame: 6 months

    Number of days of self-reported fever (≥38 ºC)

  5. Incidence of self-reported acute respiratory symptoms

    Time frame: 6 months

    Cumulative incidence of self-reported acute respiratory symptoms

  6. Days of self-reported acute respiratory symptoms

    Time frame: 6 months

    Number of days of self-reported acute respiratory symptoms

  7. Incidence of pneumonia

    Time frame: 6 months

    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

  8. Incidence of death from SARS-CoV-2 infection

    Time frame: 6 months

    Cumulative incidence of death from documented SARS-CoV-2 infection

  9. Incidence of admissions to Intensive Care Unit (ICU)

    Time frame: 6 months

    Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection

  10. Days in ICU

    Time frame: 6 months

    Number of days admitted to the ICU for documented SARS-CoV-2 infection

  11. Incidence of mechanical ventilation

    Time frame: 6 months

    Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

  12. Incidence of hospital admissions

    Time frame: 6 months

    Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

  13. Days of hospitalization

    Time frame: 6 months

    Number of days of hospitalization for documented SARS-CoV-2 infection

  14. Incidence of SARS-CoV-2 antibodies

    Time frame: Study completion, an average of 1 year

    Incidence of SARS-CoV-2 antibodies at the end of the study period

  15. Types of antibodies detected

    Time frame: Study completion, an average of 1 year

    Frequency of immunoglobulin IgG and immunoglobulin IgM

  16. Levels of SARS-CoV-2 antibodies

    Time frame: Study completion, an average of 1 year

    Levels of SARS-CoV-2 antibodies

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 6 months

    All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection as part of the associated symptoms

Sponsors and collaborators

Lead sponsor

RUTI Immunotherapeutics S.L.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 26, 2021
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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