<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/NCT04421391</url>
  </required_header>
  <id_info>
    <org_study_id>QuadraMune002</org_study_id>
    <nct_id>NCT04421391</nct_id>
  </id_info>
  <brief_title>QuadraMune(TM) for Prevention of COVID-19</brief_title>
  <official_title>Phase II Study of QuadraMune(TM) for Prevention of COVID-19 in High Risk Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Therapeutic Solutions International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Therapeutic Solutions International</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>
      QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess&#xD;
      antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies.&#xD;
      The current clinical trial aims to assess in a 500 volunteer trial the efficacy of&#xD;
      QuadraMune(TM) in reducing infection in individuals at high risk of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      QuadraMune(TM) is composed of 4 natural ingredients.&#xD;
&#xD;
      Pterostilbene is an analogue of resveratrol, and has been shown to possess antiinflammatory&#xD;
      activity. Additionally, this compound suppresses macrophage activation while enhancing NK&#xD;
      activity.&#xD;
&#xD;
      Epigallocatechin gallate (EGCG) is one of the active ingredients in green tea and has been&#xD;
      shown to act as an activator of T cells, and a suppressor of neutrophil mediated&#xD;
      inflammation.&#xD;
&#xD;
      Sulforaphane is derived from broccoli and studies have shown that it protects lungs from&#xD;
      inflammatory pathology.&#xD;
&#xD;
      Thymoquinone, which is chemically related to hydroxychloroquine, possessing antiviral effects&#xD;
      and increases NK activity.&#xD;
&#xD;
      QuadraMune is a combination of these ingredients and is believed to possess superior in vitro&#xD;
      and in vivo therapeutic properties as compared to when the ingredients are administered&#xD;
      individually.&#xD;
&#xD;
      The study aims to assess preventative effects of QuadraMune(TM) administration for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 8, 2020</start_date>
  <completion_date type="Anticipated">November 8, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of COVID-19</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Prevention of COVID-19 symptoms as recorded in a daily diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety as determined by presence or absence of Adverse Events and Serious Adverse Events</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Assessment of adverse events and serious adverse events will be performed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Covid19</condition>
  <condition>Coronavirus</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>QuadraMune(TM)</intervention_name>
    <description>QuadraMune(TM) is a commercially available nutritional supplement</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent, provided electronically via the EDC, demonstrating the subject&#xD;
             understands the procedures required for the study and the purpose of the study Male or&#xD;
             female patients 18 years of age or older that are considered to be high-risk&#xD;
             individuals.&#xD;
&#xD;
          -  High-risk individuals are defined as all health care workers in hospitals, clinics,&#xD;
             and emergency rooms, and medical facilities.&#xD;
&#xD;
          -  Subjects must agree to practice at least two highly effective methods of birth control&#xD;
             for the duration of the study This includes condoms with spermicide, oral birth&#xD;
             control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least&#xD;
             one of these must be a barrier method. Subjects not of reproductive potential will be&#xD;
             exempt (e.g. post-menopausal, surgically sterilized)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to provide informed consent Any previous positive test for COVID-19 by RT-PCR&#xD;
             Symptomatic for COVID-19 Diarrhea prior to the start of treatment Type I or II&#xD;
             diabetes Atherosclerotic Coronary Artery Disease&#xD;
&#xD;
        Any contraindication for treatment with hydroxychloroquine including:&#xD;
&#xD;
        Hypoglycemia G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia Gravis&#xD;
        Skeletal muscle disorder Maculopathy Changes in the visual field Liver disease, with&#xD;
        ALT/AST &gt; 2.5 upper limit normal and total bilirubin &gt;2.5 upper limit normal Psoriasis Any&#xD;
        comorbidities which, in the opinion of the investigator, constitute health risk for the&#xD;
        subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Veltmeyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Therapeutic Solutions International</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas E Ichim, Ph.D</last_name>
    <phone>18583534303</phone>
    <email>thomas.ichim@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Therapeutic Solutions International</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas E Ichim</last_name>
      <phone>858-353-4303</phone>
      <email>thomas.ichim@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunology</keyword>
  <keyword>Innate Immune System</keyword>
  <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>Undecided</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/NCT04421391
org study id: QuadraMune002
nct id: NCT04421391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess
      antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies.
      The current clinical trial aims to assess in a 500 volunteer trial the efficacy of
      QuadraMune(TM) in reducing infection in individuals at high risk of COVID-19.
QuadraMune(TM) is composed of 4 natural ingredients.

      Pterostilbene is an analogue of resveratrol, and has been shown to possess antiinflammatory
      activity. Additionally, this compound suppresses macrophage activation while enhancing NK
      activity.

      Epigallocatechin gallate (EGCG) is one of the active ingredients in green tea and has been
      shown to act as an activator of T cells, and a suppressor of neutrophil mediated
      inflammation.

      Sulforaphane is derived from broccoli and studies have shown that it protects lungs from
      inflammatory pathology.

      Thymoquinone, which is chemically related to hydroxychloroquine, possessing antiviral effects
      and increases NK activity.

      QuadraMune is a combination of these ingredients and is believed to possess superior in vitro
      and in vivo therapeutic properties as compared to when the ingredients are administered
      individually.

      The study aims to assess preventative effects of QuadraMune(TM) administration for 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prevention of COVID-19
time frame: 12 Weeks
description: Prevention of COVID-19 symptoms as recorded in a daily diary
measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
time frame: 12 Weeks
description: Assessment of adverse events and serious adverse events will be performed.
arm group label: Treatment Arm
arm group type: Experimental
description: Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
intervention type: Dietary Supplement
intervention name: QuadraMune(TM)
description: QuadraMune(TM) is a commercially available nutritional supplement
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James Veltmeyer, MD
role: Principal Investigator
affiliation: Therapeutic Solutions International
last name: Thomas E Ichim, Ph.D
phone: 18583534303
email: thomas.ichim@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided