<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/NCT04452773</url>
  </required_header>
  <id_info>
    <org_study_id>MANRECOVID19</org_study_id>
    <nct_id>NCT04452773</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the Efficacy of Food Supplement Manremyc® 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 Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reig Jofre Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Reig Jofre Group</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 Manremyc® food supplement for reduce&#xD;
      the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>N/A</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>% of 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>Documented sick leave for SARS-CoV-2</measure>
    <time_frame>up to 4 months (cumulative)</time_frame>
    <description>Number of days Documented as 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>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 in quarantine imposed by close contact outside the center with SARS-CoV-2 positive</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>Cumulative 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>Number of 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>Cumulative incidence of death from documented 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 admission to 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 IUC</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>Levels of IgG</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Levels of IgG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of IgM</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Levels of IgM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of SARS-CoV-2 antibodies at the end of the study period</measure>
    <time_frame>Up to 4 months</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 they will be collected as part of the associated symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>SAEs</measure>
    <time_frame>Up to 4 moths</time_frame>
    <description>All thoseAdverse 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>COVID19</condition>
  <arm_group>
    <arm_group_label>Manremyc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Manremyc</intervention_name>
    <description>Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli</description>
    <arm_group_label>Manremyc</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Same excipients than active arm without bacilli.</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. Health system workers working in contact with subjects potentially infected with&#xD;
             SARS-CoV-2.&#xD;
&#xD;
          3. People ≥ 18 years.&#xD;
&#xD;
          4. Availability to meet the requirements of the protocol.&#xD;
&#xD;
          5. Negative Rapid Serological Test of SARS-CoV-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous SARS-CoV-2 infection&#xD;
&#xD;
          2. Pregnancy or breastfeeding.&#xD;
&#xD;
          3. Suspected of active viral or bacterial infection.&#xD;
&#xD;
          4. Symptoms compatible with COVID-19, despite a negative PCR test.&#xD;
&#xD;
          5. Vaccination in the last 4 weeks or planned vaccination during the study period,&#xD;
             regardless of the type of vaccine.&#xD;
&#xD;
          6. 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;
          7. 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;
          8. Malignancy, or active solid or non-solid lymphoma from the previous two years.&#xD;
&#xD;
          9. BCG vaccination in the last 10 years.&#xD;
&#xD;
         10. Treatment with Manremyc® for the last 6 months.&#xD;
&#xD;
         11. Chloroquine or hydroxychloroquine administration in the last two weeks.&#xD;
&#xD;
         12. Direct involvement in the design or execution of the MANRECOVID19 clinical trial.&#xD;
&#xD;
         13. Retirement, transfer, long-term leave (&gt; 1 month) due to scheduled surgery or any&#xD;
             other event that makes it impossible to work in person at your health center during&#xD;
             the months following the recruitment to the study.&#xD;
&#xD;
         14. Employee at the health center &lt;22 hours per week.&#xD;
&#xD;
         15. Do not have a smartphone.&#xD;
&#xD;
         16. Detection by the investigator of lack of knowledge or willingness to participate and&#xD;
             comply with all requirements of the protocol.&#xD;
&#xD;
         17. Any other findings that, at the discretion of the investigator, may compromise&#xD;
             compliance with the protocol or that may influence significantly the interpretation or&#xD;
             the results of the effects of probiotic.&#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_contact>
    <last_name>Pere Joan Cardona, MD, PhD</last_name>
    <phone>+34934978681</phone>
    <email>pjcardona@igtp.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>CAP Cornellà (La Gavarra)</name>
      <address>
        <city>Cornellà De Llobregat</city>
        <state>Barcelona</state>
        <zip>08940</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mª Betlem Salvador, Dr.</last_name>
      <phone>+34 93 857 55 45</phone>
      <email>bsalvador@ambitcp.catsalut.net</email>
    </contact>
    <contact_backup>
      <last_name>Sofía Berlanga</last_name>
      <phone>+34 93 857 55 45</phone>
      <email>sberlanga.cp.ics@gencat.cat</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CAP Maresme</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <zip>08303</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pere Torán, Dr.</last_name>
      <phone>+34 93 741 60 73</phone>
      <email>ptoran.bnm.ics@gencat.cat</email>
    </contact>
    <contact_backup>
      <last_name>Noemí Lamonja</last_name>
      <phone>+34 93 741 60 73</phone>
      <email>noemilamonjavicente@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Cap Sant Fèlix</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08203</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Concepció Violant, Dr.</last_name>
      <phone>93 693 27 32</phone>
      <email>cviolanf.mn.ics@gencat.cat</email>
    </contact>
    <contact_backup>
      <last_name>Mª José Argerich, Dr.</last_name>
      <phone>675785198</phone>
      <email>mjargerich.mn.ics@gencat.cat</email>
    </contact_backup>
    <investigator>
      <last_name>Concepció Violant, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mª José Argerich, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EAP Riu Nord</name>
      <address>
        <city>Santa Coloma De Gramenet</city>
        <state>BArcelona</state>
        <zip>08921</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Magda Alemany, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Eli Sánchez</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Joan Matllo, Dr.</last_name>
      <phone>670282689</phone>
      <email>jmatlloaguilar@gencat.cat</email>
    </contact>
    <investigator>
      <last_name>Pere Joan Cardona, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joan Matllo, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 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/NCT04452773
org study id: MANRECOVID19
nct id: NCT04452773
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 Manremyc® food supplement for reduce
      the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.
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: % of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
measure: Documented sick leave for SARS-CoV-2
time frame: up to 4 months (cumulative)
description: Number of days Documented as sick leave for SARS-CoV-2
measure: days off work due to the quarantine
time frame: up to 4 months
description: 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 in quarantine imposed by close contact outside the center with SARS-CoV-2 positive
measure: Fever
time frame: Up to 4 months
description: Number of days of self-reported fever (≥38 ºC)
measure: Cumulative incidence of self-reported acute respiratory symptoms
time frame: up to 4 months
description: Cumulative incidence of self-reported acute respiratory symptoms
measure: Number of 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: Cumulative incidence of death from documented SARS-CoV-2 infection
time frame: Up to 4 months
description: Cumulative incidence of death from documented SARS-CoV-2 infection
measure: Incidence of admission to 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 IUC
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: Levels of IgG
time frame: Up to 4 months
description: Levels of IgG
measure: Levels of IgM
time frame: Up to 4 months
description: Levels of IgM
measure: Levels of SARS-CoV-2 antibodies at the end of the study period
time frame: Up to 4 months
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 they will be collected as part of the associated symptoms
measure: SAEs
time frame: Up to 4 moths
description: All thoseAdverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.
arm group label: Manremyc
arm group type: Experimental
description: Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast
intervention type: Dietary Supplement
intervention name: Manremyc
description: Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
arm group label: Manremyc
intervention type: Dietary Supplement
intervention name: Placebo
description: Same excipients than active arm without bacilli.
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
phone: +34934978681
email: pjcardona@igtp.cat
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No