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Corona Virus InfectionPhase 4NCT04621461

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

A Phase 4 study testing Zinc Sulfate 220 MG in people with Corona Virus Infection, run by St. Francis Hospital, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Corona Virus Infection
What is being tested?
Zinc Sulfate 220 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteUnited States
Study dates
20 Dec 2020to 8 Feb 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Francis Hospital - The Heart Center

    Roslyn, New York, 11576

Other trials in United States

About this study

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

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.

Read the 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.

Being tested
Zinc Sulfate 220 MG, Placebo
Keywords
COVID-19, Zinc
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zinc Sulfate 220 MGDietary supplement

    220mg once daily for 5 days

  • PlaceboDrug

    Once daily for 5 days

Study groups in NCT04621461
Study groupRoleWhat they receive
Experimental Arm #1Placebo comparatorPlacebo
Receives: Drug: Placebo
Experimental Arm #2ExperimentalZinc sulfate
Receives: Dietary Supplement: Zinc Sulfate 220 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 21 days

  2. 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

    Measured: 30 days

  3. Number of participants on a ventilator

    If placed on ventilator, number of days on a ventilator

    Measured: 30 days

Secondary outcomes (3)

  1. All-cause mortality

    Total number of deaths in the cohort.

    Measured: Up to 30 days

  2. Time to resolution of COVID-19 symptoms

    Time at which the patient is completely symptom free.

    Measured: Evaluated at day 2, 6, day 14, and day 21

  3. Severity of symptoms

    Scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)

    Measured: Evaluated at day 2, 6, day 14, and day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start20 Dec 2020
  3. Primary completion8 Feb 2021
  4. Study completion8 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04621461
Sponsor's protocol ID
20-19
Status last verified
Feb 2021
First submitted
6 Nov 2020
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32292689

  • 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.

    PubMed 176466

  • 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.

    PubMed 7347557

  • 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.

    PubMed 2177090

  • 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.

    PubMed 14982765

  • 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.

    PubMed 6367635

  • 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.

    PubMed 21079686

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

    PubMed 23775705

  • 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.

    PubMed 16284213

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zinc Sulfate 220 MG in people with Corona Virus Infection, run by St. Francis Hospital, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants hospitalized and/or requiring repeat emergency room visits (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04621461, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

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