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

• ClinicalTrials.gov Identifier: NCT04621149
• Recruitment Status: Terminated
• First Posted: November 9, 2020
• Last Update Posted: September 30, 2022
• Sponsor: Profact, Inc.
• Information provided by (Responsible Party): Profact, Inc.

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
COVID-19	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 (Clinical Trial)
• Actual Enrollment: 10 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.
• 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: November 15, 2020
• Actual Primary Completion Date: March 31, 2022
• Actual Study Completion Date: March 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: placebo; 1 liter of filtered water	Other: placebo; filtered water; Other Name: 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 Name: 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 Name: Pepcid; Other: placebo; filtered water; Other Name: 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 Name: 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 Name: Pepcid; Other: placebo; filtered water; Other Name: 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 Name: 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 [ Time Frame: 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 [ Time Frame: 28 days ]
   Participants will complete a daily assessment for adverse events
2. Rate of Hospitalization [ Time Frame: 28 days ]
   Admission to Hospital
3. Change in Oxygen Saturation [ Time Frame: 8 days ]
   Oxygen saturation
4. Change in Body Temperature [ Time Frame: 8 days ]
   Body temperature

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Arizona

AZ Good Health Center

Tempe, Arizona, United States, 85282

Sponsors and Collaborators

Profact, Inc.

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Profact, Inc.
• ClinicalTrials.gov Identifier: NCT04621149
• Other Study ID Numbers: Profact-01
• First Posted: November 9, 2020
• Last Update Posted: September 30, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• 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; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lactoferrin; Chlorine dioxide; Famotidine; Anti-Ulcer Agents; Gastrointestinal Agents; Histamine H2 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Infective Agents; Dental Disinfectants; Disinfectants