<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453488</url>
  </required_header>
  <id_info>
    <org_study_id>RUTICOVID19</org_study_id>
    <nct_id>NCT04453488</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers</brief_title>
  <official_title>Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut Germans Trias i Pujol</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut Germans Trias i Pujol</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2&#xD;
      infection (COVID-19) in healthcare workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2&#xD;
      infection (COVID-19) in healthcare workers. The study will include a comparison between&#xD;
      placebo and RUTI® vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 30, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Documented cumulative incidence of SARS-CoV-2 infection</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>% positive serology at the end of the study or positive PCR test in the course of routine clinical practice</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sick leave for SARS-CoV-2</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of days of documented sick leave for SARS-CoV-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days off work due to the quarantine</measure>
    <time_frame>Up to 4 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quarantine imposed by close contact outside the center with SARS-CoV-2 positive</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Professional category</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of MD, nursing, personnel management and services, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fever</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of days of self-reported fever (≥38 ºC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of self-reported acute respiratory symptoms</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Cumulative incidence of self-reported acute respiratory symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of self-reported acute respiratory symptoms</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of days of self-reported acute respiratory symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of pneumonia</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of participants with pneumonia confirmed by X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of death from SARS-CoV-2 infection</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Cumulative incidence of death from documented SARS-CoV-2 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of admissions to Intensive Care Unit (ICU)</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days in ICU</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of days admitted to the ICU for documented SARS-CoV-2 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mechanical ventilation</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hospital admissions</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of hospitalization</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Number of days of hospitalization for documented SARS-CoV-2 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of SARS-CoV-2 antibodies</measure>
    <time_frame>Final visit</time_frame>
    <description>Incidence of SARS-CoV-2 antibodies at the end of the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Types of antibodies detected</measure>
    <time_frame>Final visit</time_frame>
    <description>Frequency and levels of immunoglobulin IgG and immunoglobulin IgM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of SARS-CoV-2 antibodies</measure>
    <time_frame>Final visit</time_frame>
    <description>Levels of SARS-CoV-2 antibodies at the end of the study period</description>
  </secondary_outcome>
  <other_outcome>
    <measure>AEs</measure>
    <time_frame>Up to 4 months</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>SAEs</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>All those Adverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">315</enrollment>
  <condition>Covid-19</condition>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>RUTI® vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RUTI® vaccine</intervention_name>
    <description>Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.</description>
    <arm_group_label>RUTI® vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Physiological serum, 0.9% NaCl, will be used as a placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign the Informed Consent before initiating the selection procedures.&#xD;
&#xD;
          2. Healthcare system workers working in contact with subjects potentially infected with&#xD;
             SARS-CoV-2.&#xD;
&#xD;
          3. People ≥ 18 years.&#xD;
&#xD;
          4. Willingness to meet the requirements of the protocol.&#xD;
&#xD;
          5. Negative Rapid Serological Test of SARS-CoV-2&#xD;
&#xD;
          6. The participant must agree to use effective contraceptive methods during the study&#xD;
             period, in case of childbearing age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous SARS-CoV-2 infection&#xD;
&#xD;
          2. Pregnancy. Pregnancy test will be performed in case of doubt.&#xD;
&#xD;
          3. Breastfeeding.&#xD;
&#xD;
          4. Suspected of active viral or bacterial infection.&#xD;
&#xD;
          5. Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR)&#xD;
             test.&#xD;
&#xD;
          6. Vaccination in the last 4 weeks or planned vaccination during the study period, except&#xD;
             for influenza vaccine.&#xD;
&#xD;
          7. Participation in a research that requires experimental intervention (does not include&#xD;
             observational studies) in the previous month before signing the Consent or during the&#xD;
             study.&#xD;
&#xD;
          8. Severely immunocompromised people. This exclusion category includes:&#xD;
&#xD;
               1. Subjects with human immunodeficiency virus (HIV-1).&#xD;
&#xD;
               2. Neutropenic subjects with less than 500 neutrophils / mm3.&#xD;
&#xD;
               3. Subjects with solid organ transplantation.&#xD;
&#xD;
               4. Subjects with bone marrow transplantation.&#xD;
&#xD;
               5. Subjects undergoing chemotherapy.&#xD;
&#xD;
               6. Subjects with primary immunodeficiency.&#xD;
&#xD;
               7. Severe lymphopenia with less than 400 lymphocytes / mm3.&#xD;
&#xD;
               8. Treatment with any anti-cytokine therapy.&#xD;
&#xD;
               9. Oral treatment with steroids, defined as daily doses of 10 mg prednisone or&#xD;
                  equivalent for more than 3 months.&#xD;
&#xD;
          9. Malignancy, or active solid or non-solid lymphoma from the previous two years.&#xD;
&#xD;
         10. BCG vaccination in the last 1year.&#xD;
&#xD;
         11. Soy allergy.&#xD;
&#xD;
        12 Chloroquine or hydroxychloroquine administration in the last two weeks.&#xD;
&#xD;
        13. Direct involvement in the design or execution of the RUTICOVID19 clinical trial.&#xD;
&#xD;
        14 Retirement, transfer, long-term leave (&gt; 1 month) due to scheduled surgery or any other&#xD;
        event that makes it impossible to work in person at your health center during the months&#xD;
        following the recruitment to the study.&#xD;
&#xD;
        15. Employee at the health center &lt;22 hours per week.&#xD;
&#xD;
        16. Do not have a smartphone.&#xD;
&#xD;
        17. Detection by the researcher of lack of knowledge or willingness to participate and&#xD;
        comply with all requirements of the protocol.&#xD;
&#xD;
        18. Any other findings that, at the discretion of the researcher, may compromise compliance&#xD;
        with the protocol or that may influence significantly the interpretation or the results of&#xD;
        the effects of the vaccine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pere-Joan Cardona, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>IGTP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pere-Joan Cardona, MD, PhD</last_name>
    <phone>+34 93 033 0527</phone>
    <phone_ext>6400</phone_ext>
    <email>pjcardona@igtp.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453488
org study id: RUTICOVID19
nct id: NCT04453488
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2
      infection (COVID-19) in healthcare workers.
The aim of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2
      infection (COVID-19) in healthcare workers. The study will include a comparison between
      placebo and RUTI® vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Documented cumulative incidence of SARS-CoV-2 infection
time frame: Up to 4 months
description: % positive serology at the end of the study or positive PCR test in the course of routine clinical practice
measure: Sick leave for SARS-CoV-2
time frame: Up to 4 months
description: Number of days of documented sick leave for SARS-CoV-2
measure: Days off work due to the quarantine
time frame: Up to 4 months
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
measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
time frame: Up to 4 months
description: Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
measure: Professional category
time frame: Up to 4 months
description: Number of MD, nursing, personnel management and services, etc.
measure: Fever
time frame: Up to 4 months
description: Number of days of self-reported fever (≥38 ºC)
measure: Incidence of self-reported acute respiratory symptoms
time frame: Up to 4 months
description: Cumulative incidence of self-reported acute respiratory symptoms
measure: Days of self-reported acute respiratory symptoms
time frame: Up to 4 months
description: Number of days of self-reported acute respiratory symptoms
measure: Incidence of pneumonia
time frame: Up to 4 months
description: Number of participants with pneumonia confirmed by X-ray
measure: Incidence of death from SARS-CoV-2 infection
time frame: Up to 4 months
description: Cumulative incidence of death from documented SARS-CoV-2 infection
measure: Incidence of admissions to Intensive Care Unit (ICU)
time frame: Up to 4 months
description: Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
measure: Days in ICU
time frame: Up to 4 months
description: Number of days admitted to the ICU for documented SARS-CoV-2 infection
measure: Incidence of mechanical ventilation
time frame: Up to 4 months
description: Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
measure: Incidence of hospital admissions
time frame: Up to 4 months
description: Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
measure: Days of hospitalization
time frame: Up to 4 months
description: Number of days of hospitalization for documented SARS-CoV-2 infection
measure: Incidence of SARS-CoV-2 antibodies
time frame: Final visit
description: Incidence of SARS-CoV-2 antibodies at the end of the study period
measure: Types of antibodies detected
time frame: Final visit
description: Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
measure: Levels of SARS-CoV-2 antibodies
time frame: Final visit
description: Levels of SARS-CoV-2 antibodies at the end of the study period
measure: AEs
time frame: Up to 4 months
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.
measure: SAEs
time frame: Up to 4 months
description: All those Adverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.
arm group label: RUTI® vaccine
arm group type: Experimental
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 group label: Placebo
arm group type: Placebo Comparator
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: RUTI® vaccine
description: Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.
arm group label: RUTI® vaccine
intervention type: Biological
intervention name: Placebo
description: Physiological serum, 0.9% NaCl, will be used as a placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pere-Joan Cardona, MD, PhD
role: Study Chair
affiliation: IGTP
last name: Pere-Joan Cardona, MD, PhD
phone: +34 93 033 0527
phone ext: 6400
email: pjcardona@igtp.cat
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No