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PROFACT-01: An Outpatient Study Investigating Non-prescription Treatments for COVID-19

Sponsor
Profact, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT04621149
Collaborator
(none)
120
Enrollment
1
Location
8
Arms
4.5
Anticipated Duration (Months)
26.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: chlorine dioxide
  • Dietary Supplement: zinc acetate
  • Drug: Famotidine
  • Other: placebo
  • Dietary Supplement: lactoferrin, green tea extract
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Screening Study of Candidate Non-prescription Treatments for COVID-19: A Patient-driven, Randomized, Factorial Study Evaluating Patient-reported Outcomes (PROFACT-01)
Actual Study Start Date :
Nov 15, 2020
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo

1 liter of filtered water

Other: placebo
filtered water
Other Names:
  • filtered water

    		•
    Active Comparator: chlorine dioxide aqueous solution (AS)

    1 liter of filtered water with AS

    Other: 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.
    Active Comparator: placebo with zinc acetate (ZA)

    1 liter of filtered water with ZA

    Dietary Supplement: zinc acetate
    zinc acetate lozenges have been suggested to have antiviral properties

    Other: placebo
    filtered water
    Other Names:
  • filtered water

    		•
    Active Comparator: AS with ZA

    1 liter of filtered water with AS and ZA

    Other: 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.

    Dietary Supplement: zinc acetate
    zinc acetate lozenges have been suggested to have antiviral properties
    Active Comparator: placebo with famotidine, lactoferrin and green tea extract (FLG)

    1 liter of filtered water with FLG

    Drug: Famotidine
    famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
    Other Names:
  • Pepcid

    • Other: placebo
    filtered water
    Other Names:
  • filtered water

    • Dietary Supplement: lactoferrin, green tea extract
    lactoferrin and green tea extract are dietary supplements
    Active Comparator: AS with FLG

    1 liter of filtered water with AS and FLG

    Other: 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.

    Drug: Famotidine
    famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
    Other Names:
  • Pepcid

    • Dietary Supplement: lactoferrin, green tea extract
    lactoferrin and green tea extract are dietary supplements
    Active Comparator: placebo with ZA and FLG

    1 liter of filtered water with ZA and FLG

    Dietary Supplement: zinc acetate
    zinc acetate lozenges have been suggested to have antiviral properties

    Drug: Famotidine
    famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
    Other Names:
  • Pepcid

    • Other: placebo
    filtered water
    Other Names:
  • filtered water

    • Dietary Supplement: lactoferrin, green tea extract
    lactoferrin and green tea extract are dietary supplements
    Active Comparator: AS with ZA and FLG

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

    Other: 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.

    Dietary Supplement: zinc acetate
    zinc acetate lozenges have been suggested to have antiviral properties

    Drug: Famotidine
    famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
    Other Names:
  • Pepcid

    • Dietary Supplement: lactoferrin, green tea extract
    lactoferrin and green tea extract are dietary supplements

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in Participant Symptoms of COVID-19 [3 days]

      Symptoms of COVID-19 will be evaluated daily using a visual analogue scale

    Secondary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [28 days]

      Participants will complete a daily assessment for adverse events

    2. Rate of Hospitalization [28 days]

      Admission to Hospital

    3. Change in Oxygen Saturation [8 days]

      Oxygen saturation

    4. Change in Body Temperature [8 days]

      Body temperature

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AZ Good Health Center Tempe Arizona United States 85282

    Sponsors and Collaborators

    • Profact, Inc.

    Investigators

    • Principal Investigator: Jonathan Murphy, MD, MD(H), Profact, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Profact, Inc.
    ClinicalTrials.gov Identifier:
    NCT04621149
    Other Study ID Numbers:
    • Profact-01
    First Posted:
    Nov 9, 2020
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Lactoferrin
    Chlorine dioxide
    Famotidine

    Study Results

    No Results Posted as of Dec 29, 2020