A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of participants hospitalized and/or requiring repeat emergency room visits
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- 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.
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Experimental Arm #1
Placebo
Intervention: Placebo (Drug)
Experimental Arm #2
Zinc sulfate
Intervention: Zinc Sulfate 220 MG (Dietary Supplement)
Outcomes
Primary Outcomes
Number of participants hospitalized and/or requiring repeat emergency room visits
Time Frame: 21 days
COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit
Number of participants admitted to the Intensive care unit (ICU)
Time Frame: 30 days
If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Number of participants on a ventilator
Time Frame: 30 days
If placed on ventilator, number of days on a ventilator
Secondary Outcomes
- All-cause mortality(Up to 30 days)
- Time to resolution of COVID-19 symptoms(Evaluated at day 2, 6, day 14, and day 21)
- Severity of symptoms(Evaluated at day 2, 6, day 14, and day 21)