An Outpatient Study Investigating Non-prescription Treatments for COVID-19

COVID-19 Clinical Trial

— PROFACT-01  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04621149
• Other study ID #: Profact-01
• Status: Terminated
• Phase: Phase 2
• Start date: November 15, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2022
• Source: Profact, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• 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:
• placebo
filtered water

Dietary Supplement:
• lactoferrin, green tea extract
lactoferrin and green tea extract are dietary supplements

Locations

Country	Name	City	State
United States	AZ Good Health Center	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Profact, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Participant Symptoms of COVID-19	Symptoms of COVID-19 will be evaluated daily using a visual analogue scale	3 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Participants will complete a daily assessment for adverse events	28 days
Secondary	Rate of Hospitalization	Admission to Hospital	28 days
Secondary	Change in Oxygen Saturation	Oxygen saturation	8 days
Secondary	Change in Body Temperature	Body temperature	8 days