Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting
Purpose
This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.
Condition
- Corona Virus Infection
Eligibility
- Eligible Ages
- Over 30 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention 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.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Experimental Arm #1 |
Placebo |
|
|
Experimental Experimental Arm #2 |
Zinc sulfate |
|
Recruiting Locations
More Details
- NCT ID
- NCT04621461
- Status
- Completed
- Sponsor
- St. Francis Hospital, New York
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.