Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

October 3, 2023 updated by: Institute of Progressive Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • South Pasadena, California, United States, 91030
        • Institute of Progressive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Progressive Medicine

Investigators

  • Principal Investigator: W John Martin, MD, PhD, Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KELEA-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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