- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621461
Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting
A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
Roslyn, New York, United States, 11576
- St. Francis Hospital - The Heart Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Experimental Arm #1
Placebo
|
Once daily for 5 days
|
Experimental: Experimental Arm #2
Zinc sulfate
|
220mg once daily for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
21 days
|
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
|
30 days
|
Number of participants on a ventilator
Time Frame: 30 days
|
If placed on ventilator, number of days on a ventilator
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: Up to 30 days
|
Total number of deaths in the cohort.
|
Up to 30 days
|
Time to resolution of COVID-19 symptoms
Time Frame: Evaluated at day 2, 6, day 14, and day 21
|
Time at which the patient is completely symptom free.
|
Evaluated at day 2, 6, day 14, and day 21
|
Severity of symptoms
Time Frame: 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)
|
Evaluated at day 2, 6, day 14, and day 21
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Avni Thakore, MD, St. Francis Hospital - The Heart Center
Publications and helpful links
General Publications
- Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.
- Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, Wang Q, Xu Y, Li M, Li X, Zheng M, Chen L, Li H. Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods. Acta Pharm Sin B. 2020 May;10(5):766-788. doi: 10.1016/j.apsb.2020.02.008. Epub 2020 Feb 27.
- Korant BD, Butterworth BE. Inhibition by zinc of rhinovirus protein cleavage: interaction of zinc with capsid polypeptides. J Virol. 1976 Apr;18(1):298-306. doi: 10.1128/JVI.18.1.298-306.1976.
- Katz E, Margalith E. Inhibition of vaccinia virus maturation by zinc chloride. Antimicrob Agents Chemother. 1981 Feb;19(2):213-7. doi: 10.1128/AAC.19.2.213.
- Kumel G, Schrader S, Zentgraf H, Daus H, Brendel M. The mechanism of the antiherpetic activity of zinc sulphate. J Gen Virol. 1990 Dec;71 ( Pt 12):2989-97. doi: 10.1099/0022-1317-71-12-2989.
- Suara RO, Crowe JE Jr. Effect of zinc salts on respiratory syncytial virus replication. Antimicrob Agents Chemother. 2004 Mar;48(3):783-90. doi: 10.1128/AAC.48.3.783-790.2004.
- Eby GA, Davis DR, Halcomb WW. Reduction in duration of common colds by zinc gluconate lozenges in a double-blind study. Antimicrob Agents Chemother. 1984 Jan;25(1):20-4. doi: 10.1128/AAC.25.1.20.
- te Velthuis AJ, van den Worm SH, Sims AC, Baric RS, Snijder EJ, van Hemert MJ. Zn(2+) inhibits coronavirus and arterivirus RNA polymerase activity in vitro and zinc ionophores block the replication of these viruses in cell culture. PLoS Pathog. 2010 Nov 4;6(11):e1001176. doi: 10.1371/journal.ppat.1001176.
- Bao S, Knoell DL. Zinc modulates airway epithelium susceptibility to death receptor-mediated apoptosis. Am J Physiol Lung Cell Mol Physiol. 2006 Mar;290(3):L433-41. doi: 10.1152/ajplung.00341.2005. Epub 2005 Nov 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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