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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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COVID-19

Intervention / Treatment
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* Other: chlorine dioxide
* Dietary Supplement: zinc acetate
* Drug: Famotidine
* Other: placebo
* Dietary Supplement: lactoferrin, green tea extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 20-70 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. Ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen Exclusion Criteria: COVID-19 symptoms of a severe enough nature that requires hospitalization Pregnancy or lactation Diagnosis of diabetes mellitus currently taking paroxetine or digoxin Individuals with diabetes mellitus

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>1 liter of filtered water | Other: placebo<br>* filtered water<br>* Other names: filtered water;|
| Active Comparator: chlorine dioxide aqueous solution (AS)<br>1 liter of filtered water with AS | Other: chlorine dioxide<br>* chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.<br>|
| Active Comparator: placebo with zinc acetate (ZA)<br>1 liter of filtered water with ZA | Dietary Supplement: zinc acetate<br>* zinc acetate lozenges have been suggested to have antiviral properties<br>Other: placebo<br>* filtered water<br>* Other names: filtered water;|
| Active Comparator: AS with ZA<br>1 liter of filtered water with AS and ZA | Other: chlorine dioxide<br>* chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.<br>Dietary Supplement: zinc acetate<br>* zinc acetate lozenges have been suggested to have antiviral properties<br>|
| Active Comparator: placebo with famotidine, lactoferrin and green tea extract (FLG)<br>1 liter of filtered water with FLG | Drug: Famotidine<br>* famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid<br>* Other names: Pepcid;Other: placebo<br>* filtered water<br>* Other names: filtered water;Dietary Supplement: lactoferrin, green tea extract<br>* lactoferrin and green tea extract are dietary supplements<br>|
| Active Comparator: AS with FLG<br>1 liter of filtered water with AS and FLG | Other: chlorine dioxide<br>* chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.<br>Drug: Famotidine<br>* famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid<br>* Other names: Pepcid;Dietary Supplement: lactoferrin, green tea extract<br>* lactoferrin and green tea extract are dietary supplements<br>|
| Active Comparator: placebo with ZA and FLG<br>1 liter of filtered water with ZA and FLG | Dietary Supplement: zinc acetate<br>* zinc acetate lozenges have been suggested to have antiviral properties<br>Drug: Famotidine<br>* famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid<br>* Other names: Pepcid;Other: placebo<br>* filtered water<br>* Other names: filtered water;Dietary Supplement: lactoferrin, green tea extract<br>* lactoferrin and green tea extract are dietary supplements<br>|
| Active Comparator: AS with ZA and FLG<br>1 liter of filtered water with AS, ZA, and FLG | Other: chlorine dioxide<br>* chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.<br>Dietary Supplement: zinc acetate<br>* zinc acetate lozenges have been suggested to have antiviral properties<br>Drug: Famotidine<br>* famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid<br>* Other names: Pepcid;Dietary Supplement: lactoferrin, green tea extract<br>* lactoferrin and green tea extract are dietary supplements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Participant Symptoms of COVID-19 | Symptoms of COVID-19 will be evaluated daily using a visual analogue scale | 3 days | 

Secondary Outcome Measures

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