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Unable to recruit participants due to decline in COVID-19.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | 1 liter of filtered water |
|
| chlorine dioxide aqueous solution (AS) | Active Comparator | 1 liter of filtered water with AS |
|
| placebo with zinc acetate (ZA) | Active Comparator | 1 liter of filtered water with ZA |
|
| AS with ZA | Active Comparator | 1 liter of filtered water with AS and ZA |
|
| placebo with famotidine, lactoferrin and green tea extract (FLG) | Active Comparator | 1 liter of filtered water with FLG |
|
| AS with FLG | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlorine dioxide | Other | chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Murphy, MD, MD(H) | Profact, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Good Health Center | Tempe | Arizona | 85282 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C025109 | chlorine dioxide |
| D019345 | Zinc Acetate |
| D015738 | Famotidine |
| D007781 | Lactoferrin |
| D013662 | Tea |
| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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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.
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1 liter of filtered water with AS and FLG
|
| placebo with ZA and FLG | Active Comparator | 1 liter of filtered water with ZA and FLG |
|
| AS with ZA and FLG | Active Comparator | 1 liter of filtered water with AS, ZA, and FLG |
|
| zinc acetate | Dietary Supplement | zinc acetate lozenges have been suggested to have antiviral properties |
|
| Famotidine | Drug | famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid |
|
|
| placebo | Other | filtered water |
|
|
| lactoferrin, green tea extract | Dietary Supplement | lactoferrin and green tea extract are dietary supplements |
|
| 28 days |
| Change in Oxygen Saturation | Oxygen saturation | 8 days |
| Change in Body Temperature | Body temperature | 8 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |