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

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
chlorine dioxide
zinc acetate
Famotidine
placebo
lactoferrin, green tea extract
Sponsored by
Profact, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Good Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

placebo

chlorine dioxide aqueous solution (AS)

placebo with zinc acetate (ZA)

AS with ZA

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

AS with FLG

placebo with ZA and FLG

AS with ZA and FLG

Arm Description

1 liter of filtered water

1 liter of filtered water with AS

1 liter of filtered water with ZA

1 liter of filtered water with AS and ZA

1 liter of filtered water with FLG

1 liter of filtered water with AS and FLG

1 liter of filtered water with ZA and FLG

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Participants will complete a daily assessment for adverse events
Rate of Hospitalization
Admission to Hospital
Change in Oxygen Saturation
Oxygen saturation
Change in Body Temperature
Body temperature

Full Information

First Posted
November 5, 2020
Last Updated
September 27, 2022
Sponsor
Profact, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04621149
Brief Title
An Outpatient Study Investigating Non-prescription Treatments for COVID-19
Acronym
PROFACT-01
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit participants due to decline in COVID-19.
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Profact, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1 liter of filtered water
Arm Title
chlorine dioxide aqueous solution (AS)
Arm Type
Active Comparator
Arm Description
1 liter of filtered water with AS
Arm Title
placebo with zinc acetate (ZA)
Arm Type
Active Comparator
Arm Description
1 liter of filtered water with ZA
Arm Title
AS with ZA
Arm Type
Active Comparator
Arm Description
1 liter of filtered water with AS and ZA
Arm Title
placebo with famotidine, lactoferrin and green tea extract (FLG)
Arm Type
Active Comparator
Arm Description
1 liter of filtered water with FLG
Arm Title
AS with FLG
Arm Type
Active Comparator
Arm Description
1 liter of filtered water with AS and FLG
Arm Title
placebo with ZA and FLG
Arm Type
Active Comparator
Arm Description
1 liter of filtered water with ZA and FLG
Arm Title
AS with ZA and FLG
Arm Type
Active Comparator
Arm Description
1 liter of filtered water with AS, ZA, and FLG
Intervention Type
Other
Intervention Name(s)
chlorine dioxide
Intervention Description
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
Dietary Supplement
Intervention Name(s)
zinc acetate
Intervention Description
zinc acetate lozenges have been suggested to have antiviral properties
Intervention Type
Drug
Intervention Name(s)
Famotidine
Other Intervention Name(s)
Pepcid
Intervention Description
famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
filtered water
Intervention Description
filtered water
Intervention Type
Dietary Supplement
Intervention Name(s)
lactoferrin, green tea extract
Intervention Description
lactoferrin and green tea extract are dietary supplements
Primary Outcome Measure Information:
Title
Reduction in Participant Symptoms of COVID-19
Description
Symptoms of COVID-19 will be evaluated daily using a visual analogue scale
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Participants will complete a daily assessment for adverse events
Time Frame
28 days
Title
Rate of Hospitalization
Description
Admission to Hospital
Time Frame
28 days
Title
Change in Oxygen Saturation
Description
Oxygen saturation
Time Frame
8 days
Title
Change in Body Temperature
Description
Body temperature
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 20-70 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. Ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen Exclusion Criteria: COVID-19 symptoms of a severe enough nature that requires hospitalization Pregnancy or lactation Diagnosis of diabetes mellitus currently taking paroxetine or digoxin Individuals with diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Murphy, MD, MD(H)
Organizational Affiliation
Profact, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Good Health Center
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34473343
Citation
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.
Results Reference
derived

Learn more about this trial

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

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