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

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)

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Other: placebo; Other: chlorine dioxide; Dietary supplement: zinc acetate; Drug: Famotidine; Dietary supplement: lactoferrin, green tea extract

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85282
      • AZ Good Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / 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	Other: placebo; filtered water; Other Names: filtered water; Dietary supplement: zinc acetate; zinc acetate lozenges have been suggested to have antiviral properties
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	Other: placebo; filtered water; Other Names: filtered water; 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: 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	Other: placebo; filtered water; Other Names: filtered water; 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Participant Symptoms of COVID-19	Symptoms of COVID-19 will be evaluated daily using a visual analogue scale	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Participants will complete a daily assessment for adverse events	28 days
Rate of Hospitalization	Admission to Hospital	28 days
Change in Oxygen Saturation	Oxygen saturation	8 days
Change in Body Temperature	Body temperature	8 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Disinfectants; Histamine H2 Antagonists; Dental Disinfectants; Famotidine; Lactoferrin; Chlorine dioxide
• Other Study ID Numbers: Profact-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No