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

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

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.

Completed
Corona Virus Infection

Dietary Supplement: Zinc Sulfate 220 MG

220mg once daily for 5 days

Drug: Placebo

Once daily for 5 days

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 30 Years ~ Maximum: N/A
Countries
United States
Locations

St. Francis Hospital - The Heart Center
Roslyn, New York, United States

Avni Thakore, MD, Principal Investigator
St. Francis Hospital - The Heart Center

St. Francis Hospital, New York
NCT Number
Keywords
Covid-19
Zinc
MeSH Terms
COVID-19
Coronavirus Infections
Zinc Sulfate