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Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

Primary Purpose

Covid19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KELEA Excellerated Water
Water Without an Elevated Level of KELEA
Sponsored by
Institute of Progressive Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Energy Medicine, KELEA, Inhalation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Institute of Progressive Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treated Then Control Water

Control Than Treated Water

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals
Proportion of the Symptomatic Participants Who Become Asymptomatic Following 2-Days of Inhalation.

Full Information

First Posted
July 27, 2020
Last Updated
October 3, 2023
Sponsor
Institute of Progressive Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04490824
Brief Title
Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Progressive Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Energy Medicine, KELEA, Inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants will be sequentially assigned to receive KELEA activated or KELEA depleted water
Masking
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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated Then Control Water
Arm Type
Active Comparator
Arm 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 Title
Control Than Treated Water
Arm Type
Placebo Comparator
Arm 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(s)
KELEA Excellerated Water
Other Intervention Name(s)
KELEA Activated Water
Intervention Description
Water with increased kinetic activity as assessed by published methods of the PI
Intervention Type
Device
Intervention Name(s)
Water Without an Elevated Level of KELEA
Other Intervention Name(s)
Control Water
Intervention Description
Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.
Primary Outcome Measure Information:
Title
Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals
Description
Proportion of Covid-19 Positive Participants Who Subsequently Test Negative Following 2-Days of Inhalation.
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.
Secondary Outcome Measure Information:
Title
Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals
Description
Proportion of the Symptomatic Participants Who Become Asymptomatic Following 2-Days of Inhalation.
Time Frame
Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W John Martin, MD, PhD
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Progressive Medicine
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32066365
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.
Results Reference
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Learn more about this trial

Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

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