Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

NCT ID: NCT04490824

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-03-30

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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Participants will be sequentially assigned to receive KELEA activated or KELEA depleted water
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

KELEA Excellerated Water

Intervention Type DEVICE

Water with increased kinetic activity as assessed by published methods of the PI

Water Without an Elevated Level of KELEA

Intervention Type DEVICE

Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.

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.

Group Type PLACEBO_COMPARATOR

KELEA Excellerated Water

Intervention Type DEVICE

Water with increased kinetic activity as assessed by published methods of the PI

Water Without an Elevated Level of KELEA

Intervention Type DEVICE

Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.

Interventions

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KELEA Excellerated Water

Water with increased kinetic activity as assessed by published methods of the PI

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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KELEA Activated Water Control Water

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Progressive Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W John Martin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Director

Locations

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Institute of Progressive Medicine

South Pasadena, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32066365 (View on PubMed)

Other Identifiers

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KELEA-1

Identifier Type: -

Identifier Source: org_study_id

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