Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting

Conditions
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Corona Virus Infection

Intervention / Treatment
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* Dietary Supplement: Zinc Sulfate 220 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: abnormal lung exam abnormal oxygen saturation <95% abnormal Chest X-ray or chest CT persistent fever >100.4 degrees Fahrenheit one of the following co-morbidities: hypertension, diabetes mellitus, history of coronary artery disease, chronic kidney disease (CKD), asthma, COPD, current or former smoker, or morbid obesity (Body Mass Index ≥35) Exclusion Criteria: Severe COVID-19 requiring admission for inpatient treatment Need for any oxygen supplementation Need for mechanical ventilatory support History of oxygen supplementation dependency History of cancer with ongoing chemotherapy or radiation therapy Known hypersensitivity to zinc Severe renal disease: Glomerular Filtration Rate <30ml/min

Ages Eligible for Study
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Minimum Age: 30 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: Single Group Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Experimental Arm #1<br>Placebo | Drug: Placebo<br>* Once daily for 5 days<br>|
| Experimental: Experimental Arm #2<br>Zinc sulfate | Dietary Supplement: Zinc Sulfate 220 MG<br>* 220mg once daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Zinc