Clinical trial NCT04621149: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Profact, Inc.
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in Participant Symptoms of COVID-19
timeFrame: 3 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 28 days
measure: Rate of Hospitalization
timeFrame: 28 days
measure: Change in Oxygen Saturation
timeFrame: 8 days
measure: Change in Body Temperature
timeFrame: 8 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: AZ Good Health Center
state: Arizona
Study officials:
affiliation: Profact, Inc.
name: Jonathan Murphy, MD, MD(H)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.