<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/NCT04490824</url>
  </required_header>
  <id_info>
    <org_study_id>KELEA-1</org_study_id>
    <nct_id>NCT04490824</nct_id>
  </id_info>
  <brief_title>Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals</brief_title>
  <official_title>Can Inhalation of KELEA Excellerated Water Reduce the Time Required for Covid-19 Infected Individuals to Become Symptom-Free and to Test Negative Using Either the PCR or Antigen Assay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Progressive Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Progressive Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preliminary reports have been received from several sources that the periodic inhaling of the&#xD;
      nebulized mist from water that has a heightened level of kinetic activity has quickly (less&#xD;
      than 2 days) lessened the severity of symptoms in Covid-19 infected patients. On at least&#xD;
      several occasions, a repeat PCR test performed several after inhaling a particular&#xD;
      water-based product was negative. There are no perceived adverse effects from inhaling the&#xD;
      water mist by using a nebulizer or humidifier. It is important, however, to validate these&#xD;
      preliminary findings and to include the inhaling of the mist from water, which does not have&#xD;
      an elevated level of kinetic activity. This will be by performed in a patient-blinded manner&#xD;
      by sequentially inhaling the two types of water over consecutive 2-day periods with Covid-19&#xD;
      testing at the end of each of the two day periods. Participants will be randomized as to&#xD;
      whether they are to inhale the mist from the test or the control water.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several producers of activated water have been in frequent communication with the Principal&#xD;
      Investigator (PI) over the last decade or longer. They have regularly supplied their water&#xD;
      products to the PI for laboratory testing, including measuring an activity attributed to the&#xD;
      absorption of an environmental force, referred to by the PI as KELEA, an abbreviation for&#xD;
      Kinetic Energy Limiting Electrostatic Attraction. KELEA is regarded as the source of cellular&#xD;
      energy for the body's alternative cellular energy (ACE) pathway. This pathway can provide a&#xD;
      non-immunological defense mechanism against infections, presumably including coronaviruses.&#xD;
      The proposed study is to test water products from several suppliers, as well as a naturally&#xD;
      available source of KELEA activated water in symptomatic individuals who have tested positive&#xD;
      by either PCR or antigen testing for Covid-19. The mode of administration will be by&#xD;
      inhalation using a nebulizer or diffuser. Several deep inhalations will be taken on 5&#xD;
      occasions daily. Prior to the first inhalation and at the end of the second day of&#xD;
      inhalation, swabs will be taken for Covid-19 PCR and/or antigen testing. Randomly allocated&#xD;
      participants will either blindly first test the KELEA excellerated water for two days,&#xD;
      followed by using water without an elevated level of KELEA and vice versa. The severity of&#xD;
      symptoms will also be monitored at the end of each of the two-days periods of inhalation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Participants will be sequentially assigned to receive KELEA activated or KELEA depleted water</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participant will not be informed as to whether the item that is first received is KELEA emitting or inactive. If requested an active item will be sent following receipt of the post inhalation results.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals</measure>
    <time_frame>Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order followed by Coivid-19 testing at the end of both of the 2-days periods.</time_frame>
    <description>Proportion of Covid-19 Positive Participants Who Subsequently Test Negative Following 2-Days of Inhalation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals</measure>
    <time_frame>Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order.</time_frame>
    <description>Proportion of the Symptomatic Participants Who Become Asymptomatic Following 2-Days of Inhalation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Treated Then Control Water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This Arm includes half of the total randomly allocated participants in the study. Participants will initially inhale KELEA Excellerated Water for 2 days followed by inhaling water without an elevated level of KELEA for 2 days, with Covid-19 testing and symptom assessments performed at the ends of both of the 2 days periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Than Treated Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This Arm includes half of the total randomly allocated participants in the study. Participants will initially inhale water without an elevated level of KELEA for 2 days followed by inhaling KELEA Excellerated water for 2 days, with Covid-19 testing and symptom assessments performed at the ends of both of the 2 days periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KELEA Excellerated Water</intervention_name>
    <description>Water with increased kinetic activity as assessed by published methods of the PI</description>
    <arm_group_label>Control Than Treated Water</arm_group_label>
    <arm_group_label>Treated Then Control Water</arm_group_label>
    <other_name>KELEA Activated Water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Water Without an Elevated Level of KELEA</intervention_name>
    <description>Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.</description>
    <arm_group_label>Control Than Treated Water</arm_group_label>
    <arm_group_label>Treated Then Control Water</arm_group_label>
    <other_name>Control Water</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Individuals entering into quarantine because of a positive Covid-19&#xD;
        test using either PCR or an authorized antigen assay. It is not necessary, but preferable,&#xD;
        for the participant to be symptomatic for Covid-19 -&#xD;
&#xD;
        Exclusion Criteria: Unwilling to do repeat PCR and/or antigen testing or to provide the&#xD;
        results of the repeat testing or the requested clinical data&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>W John Martin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Progressive Medicine</name>
      <address>
        <city>South Pasadena</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Martin WJ. Enhancing the Alternative Cellular Energy (ACE) Pathway with KELEA Activated Water as Therapy for Infectious Diseases. Infect Disord Drug Targets. 2021;21(3):314-319. doi: 10.2174/1871526520666200211115111.</citation>
    <PMID>32066365</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Energy Medicine</keyword>
  <keyword>KELEA</keyword>
  <keyword>Inhalation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Aspiration</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/NCT04490824
org study id: KELEA-1
nct id: NCT04490824
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Preliminary reports have been received from several sources that the periodic inhaling of the
      nebulized mist from water that has a heightened level of kinetic activity has quickly (less
      than 2 days) lessened the severity of symptoms in Covid-19 infected patients. On at least
      several occasions, a repeat PCR test performed several after inhaling a particular
      water-based product was negative. There are no perceived adverse effects from inhaling the
      water mist by using a nebulizer or humidifier. It is important, however, to validate these
      preliminary findings and to include the inhaling of the mist from water, which does not have
      an elevated level of kinetic activity. This will be by performed in a patient-blinded manner
      by sequentially inhaling the two types of water over consecutive 2-day periods with Covid-19
      testing at the end of each of the two day periods. Participants will be randomized as to
      whether they are to inhale the mist from the test or the control water.
Several producers of activated water have been in frequent communication with the Principal
      Investigator (PI) over the last decade or longer. They have regularly supplied their water
      products to the PI for laboratory testing, including measuring an activity attributed to the
      absorption of an environmental force, referred to by the PI as KELEA, an abbreviation for
      Kinetic Energy Limiting Electrostatic Attraction. KELEA is regarded as the source of cellular
      energy for the body's alternative cellular energy (ACE) pathway. This pathway can provide a
      non-immunological defense mechanism against infections, presumably including coronaviruses.
      The proposed study is to test water products from several suppliers, as well as a naturally
      available source of KELEA activated water in symptomatic individuals who have tested positive
      by either PCR or antigen testing for Covid-19. The mode of administration will be by
      inhalation using a nebulizer or diffuser. Several deep inhalations will be taken on 5
      occasions daily. Prior to the first inhalation and at the end of the second day of
      inhalation, swabs will be taken for Covid-19 PCR and/or antigen testing. Randomly allocated
      participants will either blindly first test the KELEA excellerated water for two days,
      followed by using water without an elevated level of KELEA and vice versa. The severity of
      symptoms will also be monitored at the end of each of the two-days periods of inhalation.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Participants will be sequentially assigned to receive KELEA activated or KELEA depleted water
primary purpose: Treatment
masking: Single (Participant)
masking description: The participant will not be informed as to whether the item that is first received is KELEA emitting or inactive. If requested an active item will be sent following receipt of the post inhalation results.
measure: Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals
time frame: Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order followed by Coivid-19 testing at the end of both of the 2-days periods.
description: Proportion of Covid-19 Positive Participants Who Subsequently Test Negative Following 2-Days of Inhalation.
measure: Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals
time frame: Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order.
description: Proportion of the Symptomatic Participants Who Become Asymptomatic Following 2-Days of Inhalation.
arm group label: Treated Then Control Water
arm group type: Active Comparator
description: This Arm includes half of the total randomly allocated participants in the study. Participants will initially inhale KELEA Excellerated Water for 2 days followed by inhaling water without an elevated level of KELEA for 2 days, with Covid-19 testing and symptom assessments performed at the ends of both of the 2 days periods.
arm group label: Control Than Treated Water
arm group type: Placebo Comparator
description: This Arm includes half of the total randomly allocated participants in the study. Participants will initially inhale water without an elevated level of KELEA for 2 days followed by inhaling KELEA Excellerated water for 2 days, with Covid-19 testing and symptom assessments performed at the ends of both of the 2 days periods.
intervention type: Device
intervention name: KELEA Excellerated Water
description: Water with increased kinetic activity as assessed by published methods of the PI
arm group label: Control Than Treated Water
arm group label: Treated Then Control Water
other name: KELEA Activated Water
intervention type: Device
intervention name: Water Without an Elevated Level of KELEA
description: Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.
arm group label: Control Than Treated Water
arm group label: Treated Then Control Water
other name: Control Water
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: W John Martin, MD, PhD
role: Principal Investigator
affiliation: Medical Director
facility: 
country: United States
citation: Martin WJ. Enhancing the Alternative Cellular Energy (ACE) Pathway with KELEA Activated Water as Therapy for Infectious Diseases. Infect Disord Drug Targets. 2021;21(3):314-319. doi: 10.2174/1871526520666200211115111.
PMID: 32066365
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Respiratory Aspiration
sharing ipd: No