Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting

Corona Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621461
• Other study ID #: 20-19
• Status: Completed
• Phase: Phase 4
• Start date: December 20, 2020
• Est. completion date: February 8, 2021

Study information

• Verified date: February 2021
• Source: St. Francis Hospital, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 8, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Dietary Supplement:
• Zinc Sulfate 220 MG
220mg once daily for 5 days

Drug:
• Placebo
Once daily for 5 days

Locations

Country	Name	City	State
United States	St. Francis Hospital - The Heart Center	Roslyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Francis Hospital, New York

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Epub 2005 Nov 11. — View Citation

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. — View Citation

Katz E, Margalith E. Inhibition of vaccinia virus maturation by zinc chloride. Antimicrob Agents Chemother. 1981 Feb;19(2):213-7. — View Citation

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. — View Citation

Kümel 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. — View Citation

Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4. Review. Update in: Cochrane Database Syst Rev. 2015;(4):CD001364. — View Citation

Suara RO, Crowe JE Jr. Effect of zinc salts on respiratory syncytial virus replication. Antimicrob Agents Chemother. 2004 Mar;48(3):783-90. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants hospitalized and/or requiring repeat emergency room visits	COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit	21 days
Primary	Number of participants admitted to the Intensive care unit (ICU)	If hospitalized, number of participants admitted to the ICU, and number of days in the ICU	30 days
Primary	Number of participants on a ventilator	If placed on ventilator, number of days on a ventilator	30 days
Secondary	All-cause mortality	Total number of deaths in the cohort.	Up to 30 days
Secondary	Time to resolution of COVID-19 symptoms	Time at which the patient is completely symptom free.	Evaluated at day 2, 6, day 14, and day 21
Secondary	Severity of symptoms	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