Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04490824
• Other study ID #: KELEA-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 30, 2024

Study information

• Verified date: October 2023
• Source: Institute of Progressive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

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Related Conditions & MeSH terms

• COVID-19
• Covid19
• Respiratory Aspiration

Intervention

Device:
• KELEA Excellerated Water
Water with increased kinetic activity as assessed by published methods of the PI
• 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.

Locations

Country	Name	City	State
United States	Institute of Progressive Medicine	South Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Progressive Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.