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

• ClinicalTrials.gov Identifier: NCT04621149
• Recruitment Status: Recruiting
• First Posted: November 9, 2020
• Last Update Posted: December 29, 2020
• Sponsor: Profact, Inc.
• Information provided by (Responsible Party): Profact, Inc.

Tracking Information

• First Submitted Date: November 5, 2020
• First Posted Date: November 9, 2020
• Last Update Posted Date: December 29, 2020
• Actual Study Start Date: November 15, 2020
• Estimated Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2020)

Reduction in Participant Symptoms of COVID-19 [ Time Frame: 3 days ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 6, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Outpatient Study Investigating Non-prescription Treatments for COVID-19
• 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.
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

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

• Condition: COVID-19

Intervention

• 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

Study Arms

• Placebo Comparator: placebo
  1 liter of filtered water
  Intervention: Other: placebo
• Active Comparator: chlorine dioxide aqueous solution (AS)
  1 liter of filtered water with AS
  Intervention: Other: chlorine dioxide
• Active Comparator: placebo with zinc acetate (ZA)
  1 liter of filtered water with ZA
  Interventions:

  • Dietary Supplement: zinc acetate
  • Other: placebo
• Active Comparator: AS with ZA
  1 liter of filtered water with AS and ZA
  Interventions:

  • Other: chlorine dioxide
  • Dietary Supplement: zinc acetate
• Active Comparator: placebo with famotidine, lactoferrin and green tea extract (FLG)
  1 liter of filtered water with FLG
  Interventions:

  • Drug: Famotidine
  • Other: placebo
  • Dietary Supplement: lactoferrin, green tea extract
• Active Comparator: AS with FLG
  1 liter of filtered water with AS and FLG
  Interventions:

  • Other: chlorine dioxide
  • Drug: Famotidine
  • Dietary Supplement: lactoferrin, green tea extract
• Active Comparator: placebo with ZA and FLG
  1 liter of filtered water with ZA and FLG
  Interventions:

  • Dietary Supplement: zinc acetate
  • Drug: Famotidine
  • Other: placebo
  • Dietary Supplement: lactoferrin, green tea extract
• Active Comparator: AS with ZA and FLG
  1 liter of filtered water with AS, ZA, and FLG
  Interventions:

  • Other: chlorine dioxide
  • Dietary Supplement: zinc acetate
  • Drug: Famotidine
  • Dietary Supplement: lactoferrin, green tea extract

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 6, 2020): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2021
• Estimated Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jonathan Murphy, MD, MD(H); 3047670150; jonathan@pro-fact.org

Contact: Mitchell B Liester, MD; 7193385719; mitchell.liester@cuanschutz.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04621149
• Other Study ID Numbers: Profact-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Profact, Inc.
• Study Sponsor: Profact, Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Profact, Inc.
• Verification Date: December 2020