<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/NCT04452643</url>
  </required_header>
  <id_info>
    <org_study_id>MV130-SLG-037</org_study_id>
    <nct_id>NCT04452643</nct_id>
  </id_info>
  <brief_title>Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel</brief_title>
  <acronym>Bacmune</acronym>
  <official_title>Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inmunotek S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inmunotek S.L.</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 trial is to assess the effect of immunotherapy with the bacterial&#xD;
      preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets,&#xD;
      as is the case with healthcare personnel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical&#xD;
      trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to&#xD;
      SARS-VoC-2 infection in healthcare personnel&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not authorized by Cofepris (Mexico Competent Regulatory Authority)&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>
    <intervention_model_description>Double blind placebo control</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double blind placebo control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of subjects with COVID-19</measure>
    <time_frame>60 days</time_frame>
    <description>Incidence of subjects with COVID-19, defined by the presence of:&#xD;
Fever&#xD;
Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction.&#xD;
Positive test for SARS-COV-2 (PCR o serology)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of COVID-19</measure>
    <time_frame>60 days</time_frame>
    <description>Incidence of severe COVID-19, defined by CURB &gt; 2 and/or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroconversion to SARS-CoV-2</measure>
    <time_frame>60 days</time_frame>
    <description>Rate of subjects with seroconversion to SARS-CoV-2 (negative serology at the beginning of the study and positive at the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects with symptoms</measure>
    <time_frame>60 days</time_frame>
    <description>Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission due to COVID-19</measure>
    <time_frame>60 days</time_frame>
    <description>The effect of the treatment on the severity of the disease will be measured based on the rate of subjects requiring hospital admission for COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to an intensive care unit due to COVID-19</measure>
    <time_frame>60 days</time_frame>
    <description>The effect of the treatment on the severity of the disease will be measured based on the rate of subjects who require admission to an intensive care unit for COVID-19&#xD;
• Time from confirmation of SARS-CoV-2 infection to the appearance of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elapsed time until hospitalization</measure>
    <time_frame>60 days</time_frame>
    <description>Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elapsed time until admission into an care unit for COVID-19</measure>
    <time_frame>60 days</time_frame>
    <description>Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elapsed time until death not related to COVID-19</measure>
    <time_frame>60 days</time_frame>
    <description>Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Bacmune (MV130)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BACMUNE (MV130)</intervention_name>
    <description>BACMUNE (MV130) is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU / mL (approx. 10^9 bacteria / mL)</description>
    <arm_group_label>Bacmune (MV130)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is a solution on sodium chloride at 0.9%</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health personnel who are or have been in contact with patients with disease due to&#xD;
             SARS-COV-2 infection within the last 14 days before randomization.&#xD;
&#xD;
          -  Negative result for test against COVID-19.&#xD;
&#xD;
          -  Subjects who have given informed consent.&#xD;
&#xD;
          -  Men or women aged between 18 and 65 years, both included.&#xD;
&#xD;
          -  Subjects who have a smartphone where they can load an APP for monitoring the symptoms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are participating in another clinical trial.&#xD;
&#xD;
          -  Subjects who are unable to offer cooperation and/or have serious psychiatric&#xD;
             disorders.&#xD;
&#xD;
          -  Subjects who are allergic to any of the compounds included into MV130.&#xD;
&#xD;
          -  Subjects who present contraindications to any of the components of BACMUNE (MV130).&#xD;
&#xD;
          -  Subjects who are not able to comply with the dosage regimen.&#xD;
&#xD;
          -  Subjects with immunodeficiencies.&#xD;
&#xD;
          -  Subjects with malignancy involving the bone marrow or lymphoid systems.&#xD;
&#xD;
          -  Pregnant or suspected pregnant women and breastfeeding women.&#xD;
&#xD;
          -  Subjects in medical treatment that affects the response of the immune system. It&#xD;
             includes corticosteroids (equal to or more than 20 mg for more than 2 weeks),&#xD;
             immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies,&#xD;
             etc.).&#xD;
&#xD;
          -  Subjects with HIV.&#xD;
&#xD;
          -  Subjects under treatment with metformin.&#xD;
&#xD;
          -  Subjects treated with Sertraline.&#xD;
&#xD;
          -  Subjects treated with statins.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosaura Esperanza Benitez Pérez</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_official>
    <last_name>Felipe Monrroy López</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_official>
    <last_name>Blanca Nohemí Zamora Mendoza</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Enfermedades Respiratorias (INER)</name>
      <address>
        <city>Ciudad de México</city>
        <zip>Ciudad de México</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Pachuca</name>
      <address>
        <city>Pachuca de Soto</city>
        <zip>42070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Ciudad Valles</name>
      <address>
        <city>San Luis Potosí</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 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/NCT04452643
org study id: MV130-SLG-037
nct id: NCT04452643
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this trial is to assess the effect of immunotherapy with the bacterial
      preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets,
      as is the case with healthcare personnel.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical
      trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to
      SARS-VoC-2 infection in healthcare personnel
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind placebo control
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double blind placebo control
measure: Incidence of subjects with COVID-19
time frame: 60 days
description: Incidence of subjects with COVID-19, defined by the presence of:
Fever
Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction.
Positive test for SARS-COV-2 (PCR o serology)
measure: Severity of COVID-19
time frame: 60 days
description: Incidence of severe COVID-19, defined by CURB > 2 and/or death
measure: Seroconversion to SARS-CoV-2
time frame: 60 days
description: Rate of subjects with seroconversion to SARS-CoV-2 (negative serology at the beginning of the study and positive at the end of the study
measure: Subjects with symptoms
time frame: 60 days
description: Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
measure: Hospital admission due to COVID-19
time frame: 60 days
description: The effect of the treatment on the severity of the disease will be measured based on the rate of subjects requiring hospital admission for COVID-19
measure: Admission to an intensive care unit due to COVID-19
time frame: 60 days
description: The effect of the treatment on the severity of the disease will be measured based on the rate of subjects who require admission to an intensive care unit for COVID-19
• Time from confirmation of SARS-CoV-2 infection to the appearance of symptoms.
measure: Elapsed time until hospitalization
time frame: 60 days
description: Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.
measure: Elapsed time until admission into an care unit for COVID-19
time frame: 60 days
description: Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.
measure: Elapsed time until death not related to COVID-19
time frame: 60 days
description: Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.
arm group label: Bacmune (MV130)
arm group type: Active Comparator
description: Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days.
intervention type: Biological
intervention name: BACMUNE (MV130)
description: BACMUNE (MV130) is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU / mL (approx. 10^9 bacteria / mL)
arm group label: Bacmune (MV130)
intervention type: Other
intervention name: Placebo
description: Placebo is a solution on sodium chloride at 0.9%
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rosaura Esperanza Benitez Pérez
role: Principal Investigator
last name: Felipe Monrroy López
role: Principal Investigator
last name: Blanca Nohemí Zamora Mendoza
role: Principal Investigator
facility: 
facility: 
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No