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)
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.

Terminated
COVID-19

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 Name: Pepcid

Other: placebo

filtered water
Other Name: filtered water

Dietary Supplement: lactoferrin, green tea extract

lactoferrin and green tea extract are dietary supplements

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 70 Years
Countries
United States
Locations

AZ Good Health Center
Tempe, Arizona, United States

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

Profact, Inc.
NCT Number
MeSH Terms
COVID-19
Lactoferrin
Chlorine dioxide
Famotidine