Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Device: KELEA Excellerated Water
* Device: Water Without an Elevated Level of KELEA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals entering into quarantine because of a positive Covid-19 test using either PCR or an authorized antigen assay. It is not necessary, but preferable, for the participant to be symptomatic for Covid-19 - Exclusion Criteria: Unwilling to do repeat PCR and/or antigen testing or to provide the results of the repeat testing or the requested clinical data -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Participants will be sequentially assigned to receive KELEA activated or KELEA depleted water
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treated Then Control Water<br>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. | Device: KELEA Excellerated Water<br>* Water with increased kinetic activity as assessed by published methods of the PI<br>* Other names: KELEA Activated Water;Device: Water Without an Elevated Level of KELEA<br>* Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.<br>* Other names: Control Water;|
| Placebo Comparator: Control Than Treated Water<br>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. | Device: KELEA Excellerated Water<br>* Water with increased kinetic activity as assessed by published methods of the PI<br>* Other names: KELEA Activated Water;Device: Water Without an Elevated Level of KELEA<br>* Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.<br>* Other names: Control Water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals | Proportion of Covid-19 Positive Participants Who Subsequently Test Negative Following 2-Days of Inhalation. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals | Proportion of the Symptomatic Participants Who Become Asymptomatic Following 2-Days of Inhalation. | Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy Medicine, KELEA, Inhalation