Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

NCT04490824 | Unknown FDA Device

• 1 other identifier: KELEA-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Energy Medicine; KELEA; Inhalation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals

  Two consecutive 2-days periods of sequential inhalation of test and control water in randomized order.

Study Arms (2)

Treated Then Control Water

ACTIVE COMPARATOR

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; Device: Water Without an Elevated Level of KELEA

Control Than Treated Water

PLACEBO COMPARATOR

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; Device: Water Without an Elevated Level of KELEA

Interventions

KELEA Excellerated Water DEVICE

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

Also known as: KELEA Activated Water

Control Than Treated Water; Treated Then Control Water

Water Without an Elevated Level of KELEA DEVICE

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

Also known as: Control Water

Control Than Treated Water; Treated Then Control Water

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Institute of Progressive Medicine: lead

Study Sites (1)

Institute of Progressive Medicine

South Pasadena, California, 91030, United States

Location

Related 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.

  PMID: 32066365 BACKGROUND

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• W John Martin, MD, PhD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be sequentially assigned to receive KELEA activated or KELEA depleted water

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 29, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: March 30, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)