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Difficulty accruing patients
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Administration of Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period in covid-19 positive patients in an outpatient setting
Research Question: In ambulatory, non-hospitalized patients with SARS-CoV-2 infection, is it possible to utilize resveratrol as a transporter for zinc treatment as means to minimize viral load and severity of resulting COVID-19 disease?
60 ambulatory SARS-CoV-2 positive volunteers who will be randomized into one of two treatment arms to receive either Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period. It is anticipated to take approximately 20 weeks to accrue this cohort resulting in an estimated active project period of 22 weeks, although it may take up to 12 additional weeks to collect all of the data related to COVID-19 admissions in the cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol and Zinc Picolinate combination therapy | Active Comparator | Resveratrol and Zinc Picolinate combination therapy |
|
| Resveratrol Placebo and Zinc Placebo combination therapy | Placebo Comparator | Placebo Resveratrol and Placebo Zinc combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Picolinate | Dietary Supplement | Zinc Picolinate (50 mg PO TID x 5 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in SARS-CoV-2 Viral load | Viral AUCs normalized to peak viral load and housekeeper genes will be calculated, the AUCs on subjects with complete data will be used as dependent measures in t-tests, regressions and repeated measures mixed ANOVAs to compare viral load reduction between groups | 1 year |
| Reduction in Severity of COVID-19 Disease | Review of healthcare resource utilization during study period | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hank Kaplan, MD | Swedish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
Currently no plan to make IPD available
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C030614 | picolinic acid |
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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Placebo controlled Resveratrol and Zinc combination therapy
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single blinded
| Resveratrol | Dietary Supplement | Resveratrol 2 grams po BID x 5 days |
|
| Zinc Picolinate Placebo | Dietary Supplement | Zinc Picolinate Matched Placebo PO TID x 5 days |
|
| Resveratrol Placebo | Dietary Supplement | Resveratrol Matched Placebo PO BID x 5 days |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |