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

NCT04621461 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 20-19
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection

Keywords

COVID-19; Zinc

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Number of participants on a ventilator

  If placed on ventilator, number of days on a ventilator

  30 days

Secondary Outcomes (3)

• 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

Study Arms (2)

Experimental Arm #1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Experimental Arm #2

EXPERIMENTAL

Zinc sulfate

Dietary Supplement: Zinc Sulfate 220 MG

Interventions

Zinc Sulfate 220 MG DIETARY_SUPPLEMENT

220mg once daily for 5 days

Experimental Arm #2

Placebo DRUG

Once daily for 5 days

Experimental Arm #1

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Francis Hospital, New York: lead

Study Sites (1)

St. Francis Hospital - The Heart Center

Roslyn, New York, 11576, United States

Location

Related Publications (9)

• 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.

  PMID: 32292689 BACKGROUND

• 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.

  PMID: 176466 BACKGROUND

• 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.

  PMID: 7347557 BACKGROUND

• 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.

  PMID: 2177090 BACKGROUND

• 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.

  PMID: 14982765 BACKGROUND

• 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.

  PMID: 6367635 BACKGROUND

• 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.

  PMID: 21079686 BACKGROUND

• Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.

  PMID: 23775705 BACKGROUND

• 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.

  PMID: 16284213 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Avni Thakore, MD

  St. Francis Hospital - The Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 9, 2020
• Study Start: December 20, 2020
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)