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This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.
Zinc, a micronutrient, appears to have anti-viral properties with various mechanisms of action depending on the concentration Zinc supplementation has been reviewed extensively for use in the common cold, and has been shown to reduce the duration of symptoms. In-vitro studies have shown zinc can inhibit RNA-dependent RNA polymerase (RdRP) in coronavirus, which is typically a conserved region in the viral genome. In-vitro experiments have also shown that lung epithelium in a zinc depleted state can become susceptible to apoptosis and loss of barrier function, increasing permeability, which can lead to acute respiratory distress syndrome (ARDS).
If a patient can travel to St. Francis Hospital they can have a COVID test on site at a designated St. Francis testing location. The COVID test will be resulted via a rapid Covid (Point of Care device) or at a local lab.
Patients who are unable to travel to St. Francis Hospital or one of the outpatient practices, will be allowed to enroll remotely. Patients are eligible to enroll within 72 hours of a positive Covid-19 test result. Study medications will be mailed to the patient overnight after being enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm #1 | Placebo Comparator | Placebo |
|
| Experimental Arm #2 | Experimental | Zinc sulfate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Sulfate 220 MG | Dietary Supplement | 220mg once daily for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants hospitalized and/or requiring repeat emergency room visits | COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit | 21 days |
| Number of participants admitted to the Intensive care unit (ICU) | If hospitalized, number of participants admitted to the ICU, and number of days in the ICU | 30 days |
| Number of participants on a ventilator | If placed on ventilator, number of days on a ventilator | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Total number of deaths in the cohort. | Up to 30 days |
| Time to resolution of COVID-19 symptoms | Time at which the patient is completely symptom free. |
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Inclusion Criteria:
Able to read and understand informed consent.
High initial clinical suspicion by physician based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by confirmation of COVID-19 diagnosis
Any gender
Age 60 years and older
Age 30-59 years with one or more of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avni Thakore, MD | St. Francis Hospital - The Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Francis Hospital - The Heart Center | Roslyn | New York | 11576 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32292689 | Background | Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, Wang Q, Xu Y, Li M, Li X, Zheng M, Chen L, Li H. Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods. Acta Pharm Sin B. 2020 May;10(5):766-788. doi: 10.1016/j.apsb.2020.02.008. Epub 2020 Feb 27. | |
| 176466 | Background |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Not provided
| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population. Patients will randomized to zinc or placebo.
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Patients will be randomized via a randomization block. Only the research coordinator will know which group the patients belong to. Placebo pills given to the patient will be similar in size and shape to zinc.
| Placebo |
| Drug |
Once daily for 5 days |
|
| Evaluated at day 2, 6, day 14, and day 21 |
| Severity of symptoms | Scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe) | Evaluated at day 2, 6, day 14, and day 21 |
| Korant BD, Butterworth BE. Inhibition by zinc of rhinovirus protein cleavage: interaction of zinc with capsid polypeptides. J Virol. 1976 Apr;18(1):298-306. doi: 10.1128/JVI.18.1.298-306.1976. |
| 7347557 | Background | Katz E, Margalith E. Inhibition of vaccinia virus maturation by zinc chloride. Antimicrob Agents Chemother. 1981 Feb;19(2):213-7. doi: 10.1128/AAC.19.2.213. |
| 2177090 | Background | Kumel G, Schrader S, Zentgraf H, Daus H, Brendel M. The mechanism of the antiherpetic activity of zinc sulphate. J Gen Virol. 1990 Dec;71 ( Pt 12):2989-97. doi: 10.1099/0022-1317-71-12-2989. |
| 14982765 | Background | Suara RO, Crowe JE Jr. Effect of zinc salts on respiratory syncytial virus replication. Antimicrob Agents Chemother. 2004 Mar;48(3):783-90. doi: 10.1128/AAC.48.3.783-790.2004. |
| 6367635 | Background | Eby GA, Davis DR, Halcomb WW. Reduction in duration of common colds by zinc gluconate lozenges in a double-blind study. Antimicrob Agents Chemother. 1984 Jan;25(1):20-4. doi: 10.1128/AAC.25.1.20. |
| 21079686 | Background | te Velthuis AJ, van den Worm SH, Sims AC, Baric RS, Snijder EJ, van Hemert MJ. Zn(2+) inhibits coronavirus and arterivirus RNA polymerase activity in vitro and zinc ionophores block the replication of these viruses in cell culture. PLoS Pathog. 2010 Nov 4;6(11):e1001176. doi: 10.1371/journal.ppat.1001176. |
| 23775705 | Background | Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4. |
| 16284213 | Background | Bao S, Knoell DL. Zinc modulates airway epithelium susceptibility to death receptor-mediated apoptosis. Am J Physiol Lung Cell Mol Physiol. 2006 Mar;290(3):L433-41. doi: 10.1152/ajplung.00341.2005. Epub 2005 Nov 11. |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |