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

Primary Purpose

Covid-19

Status
Completed
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
RUTI® vaccine
Placebo
Sponsored by
RUTI Immunotherapeutics S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital General de Agudos Dr. Ignacio Pirovano
  • Hospital Italiano de Buenos Aires
  • Hospital General
  • Hospital José Néstor Lencinas
  • Hospital Materno Infantil "Dr. Héctor Quintana"
  • Hospital de Clínicas Presidente Dr. Nicolás Avellaneda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group RUTI

Group Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 21, 2021
Last Updated
January 25, 2023
Sponsor
RUTI Immunotherapeutics S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04903184
Brief Title
Exploratory Study to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
November 11, 2021 (Actual)
Study Completion Date
November 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RUTI Immunotherapeutics S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group RUTI
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
RUTI® vaccine
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Physiological serum, 0.9% NaCl, will be used as a placebo.
Primary Outcome Measure Information:
Title
Documented cumulative incidence of SARS-CoV-2 infection
Description
Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Sick leave for SARS-CoV-2
Description
Number of days of documented sick leave for SARS-CoV-2
Time Frame
6 months
Title
Days off work due to the quarantine
Description
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
6 months
Title
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Description
Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Time Frame
6 months
Title
Fever
Description
Number of days of self-reported fever (≥38 ºC)
Time Frame
6 months
Title
Incidence of self-reported acute respiratory symptoms
Description
Cumulative incidence of self-reported acute respiratory symptoms
Time Frame
6 months
Title
Days of self-reported acute respiratory symptoms
Description
Number of days of self-reported acute respiratory symptoms
Time Frame
6 months
Title
Incidence of pneumonia
Description
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
Time Frame
6 months
Title
Incidence of death from SARS-CoV-2 infection
Description
Cumulative incidence of death from documented SARS-CoV-2 infection
Time Frame
6 months
Title
Incidence of admissions to Intensive Care Unit (ICU)
Description
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Time Frame
6 months
Title
Days in ICU
Description
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Time Frame
6 months
Title
Incidence of mechanical ventilation
Description
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Time Frame
6 months
Title
Incidence of hospital admissions
Description
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Time Frame
6 months
Title
Days of hospitalization
Description
Number of days of hospitalization for documented SARS-CoV-2 infection
Time Frame
6 months
Title
Incidence of SARS-CoV-2 antibodies
Description
Incidence of SARS-CoV-2 antibodies at the end of the study period
Time Frame
Study completion, an average of 1 year
Title
Types of antibodies detected
Description
Frequency of immunoglobulin IgG and immunoglobulin IgM
Time Frame
Study completion, an average of 1 year
Title
Levels of SARS-CoV-2 antibodies
Description
Levels of SARS-CoV-2 antibodies
Time Frame
Study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital General de Agudos Dr. Ignacio Pirovano
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Hospital General
City
Mendoza
Country
Argentina
Facility Name
Hospital José Néstor Lencinas
City
Mendoza
Country
Argentina
Facility Name
Hospital Materno Infantil "Dr. Héctor Quintana"
City
San Salvador De Jujuy
Country
Argentina
Facility Name
Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
City
Tucumán
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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