Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621149
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Profact, Inc.

Tracking Information
First Submitted Date  ICMJE November 5, 2020
First Posted Date  ICMJE November 9, 2020
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE November 15, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Outpatient Study Investigating Non-prescription Treatments for COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE COVID-19
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan Murphy, MD, MD(H) 3047670150 jonathan@pro-fact.org
Contact: Mitchell B Liester, MD 7193385719 mitchell.liester@cuanschutz.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04621149
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Profact, Inc.
Study Sponsor  ICMJE Profact, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Murphy, MD, MD(H) Profact, Inc.
PRS Account Profact, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP