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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621149


Contacts
Layout table for location contacts
Contact: Jonathan Murphy, MD, MD(H) 3047670150 jonathan@pro-fact.org
Contact: Mitchell B Liester, MD 7193385719 mitchell.liester@cuanschutz.edu

Locations
Layout table for location information
United States, Arizona
AZ Good Health Center Recruiting
Tempe, Arizona, United States, 85282
Contact: Jonathan Murphy, MD         
Sponsors and Collaborators
Profact, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Murphy, MD, MD(H) Profact, Inc.
Layout table for additonal information
Responsible Party: Profact, Inc.
ClinicalTrials.gov Identifier: NCT04621149    
Other Study ID Numbers: Profact-01
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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