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The purpose of this research study is to look at high dose zinc versus multivitamin micronutrient supplementation to support immune health in the setting of the COVID-19 pandemic.
This is a two-cohort prospective randomized study intended to test the role of Zinc versus multivitamin supplementation in supporting immune health in the setting of the COVID-19 pandemic. Individuals over 50 years old or primary health care professionals over the age of 18 who have had no evidence of prior COVID-19 infection and who have been asymptomatic for 7 days prior to enrollment will be randomized at the individual level to take either PreserVision AREDS formulation soft gels or tablets with 69.6mg/day Zinc supplementation or to receive a multivitamin supplement with 11mg of zinc/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose Zinc (PreserVision AREDS formulation soft gels or tablets) | Active Comparator | Subjects will have a high dose Zinc supplementation in combination with Copper, Vitamin C/E and beta-carotene |
|
| Multivitamin with 11mg of zinc | Active Comparator | Subjects in this arm will have a multivitamin supplement with 11mg of zinc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PreserVision AREDS formulation soft gels or tablets | Dietary Supplement | Two tabs taken daily for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 illness requiring hospitalization | Total number of subjects admitted to the hospital in relations to COVID-19 illness PCR or undergo seroconversion | Through study completion, approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Illness without hospitalization | Total number of subjects with COVID-19 illness that are not hospitalized | Through study completion, approximately 3 months |
| Supplemental oxygen therapy during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
History of positive or indeterminate COVID PCR test prior to screening or Elecsys Anti-SARS-CoV-2 immunoassay antibody test positive or indeterminate at screening
Active symptoms of COVID ((a fever of 100.0o F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation)) in past 7 days
Known intolerance to multivitamins or zinc supplements from prior exposure
Inability to complete follow-up questions or grant access to electronic health record for surveillance
Have had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 in past 14 days
Current or former smoker less than 5 years ago
Pregnant or breastfeeding
Prisoner
Any subject with known immunosuppressed state, including
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| Name | Affiliation | Role |
|---|---|---|
| Atta Behfar, MD, PhD | Mayo Clinic | Principal Investigator |
| Albert Hakaim, MD | Mayo Clinic | Principal Investigator |
| Ayan Sen, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Jacksonville |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| C067316 | Geritol |
| D015032 | Zinc |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D019216 | Metals, Heavy |
| D004602 | Elements |
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| Multivitamin with 11mg of zinc | Dietary Supplement | One tab taken daily for three months |
|
Total number of subjects to require supplemental oxygen therapy during hospitalization for COVID-19
| Through study completion, approximately 3 months |
| Invasive ventilation during hospitalization | Total number of subjects to require invasive ventilation during hospitalization for COVID-19 | Through study completion, approximately 3 months |
| Mortality | Total number of subject deaths | Through study completion, approximately 3 months |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| D007287 |
| Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |