Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting
- Conditions
- Corona Virus Infection
- Interventions
- Drug: PlaceboDietary Supplement: Zinc Sulfate 220 MG
- Registration Number
- NCT04621461
- Lead Sponsor
- St. Francis Hospital, New York
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
-
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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Arm #1 Placebo Placebo Experimental Arm #2 Zinc Sulfate 220 MG Zinc sulfate
- Primary Outcome Measures
Name Time Method Number of participants admitted to the Intensive care unit (ICU) 30 days If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Number of participants on a ventilator 30 days If placed on ventilator, number of days on a ventilator
Number of participants hospitalized and/or requiring repeat emergency room visits 21 days COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit
- Secondary Outcome Measures
Name Time Method All-cause mortality Up to 30 days Total number of deaths in the cohort.
Time to resolution of COVID-19 symptoms Evaluated at day 2, 6, day 14, and day 21 Time at which the patient is completely symptom free.
Severity of symptoms Evaluated at day 2, 6, day 14, and day 21 Scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)
Trial Locations
- Locations (1)
St. Francis Hospital - The Heart Center
🇺🇸Roslyn, New York, United States