An Outpatient Study Investigating Non-prescription Treatments for COVID-19

NCT ID: NCT04621149

Last Updated: 2022-09-30

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-03-31

Brief Summary

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This is a platform study to investigate the effectiveness of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently tested positive for COVID-19.

Detailed Description

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This study will screen for the activity of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently diagnosed with COVID-19. This will be a randomized, blinded placebo-controlled study with respect to the active treatment (chlorine dioxide) vs placebo, and randomized open-label with respect to a non-prescription medication (famotidine) and supplements including zinc, EGCG and lactoferrin. Treatment will last for 7 days.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This will be a randomized, blinded placebo-controlled study with respect to the active treatment vs placebo, and randomized open-label with respect to non-prescription medicine and supplements.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

1 liter of filtered water

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

filtered water

chlorine dioxide aqueous solution (AS)

1 liter of filtered water with AS

Group Type ACTIVE_COMPARATOR

chlorine dioxide

Intervention Type OTHER

chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.

placebo with zinc acetate (ZA)

1 liter of filtered water with ZA

Group Type ACTIVE_COMPARATOR

zinc acetate

Intervention Type DIETARY_SUPPLEMENT

zinc acetate lozenges have been suggested to have antiviral properties

placebo

Intervention Type OTHER

filtered water

AS with ZA

1 liter of filtered water with AS and ZA

Group Type ACTIVE_COMPARATOR

chlorine dioxide

Intervention Type OTHER

chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.

zinc acetate

Intervention Type DIETARY_SUPPLEMENT

zinc acetate lozenges have been suggested to have antiviral properties

placebo with famotidine, lactoferrin and green tea extract (FLG)

1 liter of filtered water with FLG

Group Type ACTIVE_COMPARATOR

Famotidine

Intervention Type DRUG

famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid

placebo

Intervention Type OTHER

filtered water

lactoferrin, green tea extract

Intervention Type DIETARY_SUPPLEMENT

lactoferrin and green tea extract are dietary supplements

AS with FLG

1 liter of filtered water with AS and FLG

Group Type ACTIVE_COMPARATOR

chlorine dioxide

Intervention Type OTHER

chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.

Famotidine

Intervention Type DRUG

famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid

lactoferrin, green tea extract

Intervention Type DIETARY_SUPPLEMENT

lactoferrin and green tea extract are dietary supplements

placebo with ZA and FLG

1 liter of filtered water with ZA and FLG

Group Type ACTIVE_COMPARATOR

zinc acetate

Intervention Type DIETARY_SUPPLEMENT

zinc acetate lozenges have been suggested to have antiviral properties

Famotidine

Intervention Type DRUG

famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid

placebo

Intervention Type OTHER

filtered water

lactoferrin, green tea extract

Intervention Type DIETARY_SUPPLEMENT

lactoferrin and green tea extract are dietary supplements

AS with ZA and FLG

1 liter of filtered water with AS, ZA, and FLG

Group Type ACTIVE_COMPARATOR

chlorine dioxide

Intervention Type OTHER

chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.

zinc acetate

Intervention Type DIETARY_SUPPLEMENT

zinc acetate lozenges have been suggested to have antiviral properties

Famotidine

Intervention Type DRUG

famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid

lactoferrin, green tea extract

Intervention Type DIETARY_SUPPLEMENT

lactoferrin and green tea extract are dietary supplements

Interventions

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chlorine dioxide

chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.

Intervention Type OTHER

zinc acetate

zinc acetate lozenges have been suggested to have antiviral properties

Intervention Type DIETARY_SUPPLEMENT

Famotidine

famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid

Intervention Type DRUG

placebo

filtered water

Intervention Type OTHER

lactoferrin, green tea extract

lactoferrin and green tea extract are dietary supplements

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Pepcid filtered water

Eligibility Criteria

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Inclusion Criteria

1. Signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 20-70
4. Confirmed diagnosis of COVID-19 by positive COVID-19 test. Symptoms of a mild degree such that hospitalization is not required. Within 7 days of symptom onset.
5. Ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen

Exclusion Criteria

1. COVID-19 symptoms of a severe enough nature that requires hospitalization
2. Pregnancy or lactation
3. Diagnosis of diabetes mellitus
4. currently taking paroxetine or digoxin
5. Individuals with diabetes mellitus
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Profact, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Murphy, MD, MD(H)

Role: PRINCIPAL_INVESTIGATOR

Profact, Inc.

Locations

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AZ Good Health Center

Tempe, Arizona, United States

Site Status

Countries

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United States

References

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Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

Other Identifiers

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Profact-01

Identifier Type: -

Identifier Source: org_study_id

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