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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621461
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Dietary Supplement: Zinc Sulfate 220 MG Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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 (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting
Actual Study Start Date : December 20, 2020
Actual Primary Completion Date : February 8, 2021
Actual Study Completion Date : February 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Experimental Arm #1
Placebo
Drug: Placebo
Once daily for 5 days

Experimental: Experimental Arm #2
Zinc sulfate
Dietary Supplement: Zinc Sulfate 220 MG
220mg once daily for 5 days




Primary Outcome Measures :
  1. 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

  2. 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

  3. Number of participants on a ventilator [ Time Frame: 30 days ]
    If placed on ventilator, number of days on a ventilator


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Up to 30 days ]
    Total number of deaths in the cohort.

  2. 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.

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621461


Locations
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United States, New York
St. Francis Hospital - The Heart Center
Roslyn, New York, United States, 11576
Sponsors and Collaborators
St. Francis Hospital, New York
Investigators
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Principal Investigator: Avni Thakore, MD St. Francis Hospital - The Heart Center
Publications:

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Responsible Party: St. Francis Hospital, New York
ClinicalTrials.gov Identifier: NCT04621461    
Other Study ID Numbers: 20-19
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Francis Hospital, New York:
COVID-19
Zinc
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Zinc Sulfate
Astringents
Physiological Effects of Drugs
Dermatologic Agents