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Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 (ZnCOVID-19)

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: NCT04551339
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Atta Behfar, Mayo Clinic

Study Description
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Brief Summary:
The purpose of this research study is to look at high dose zinc versus multivitamin micronutrient supplementation to support immune health in the setting of the COVID-19 pandemic.

Condition or disease Intervention/treatment Phase
Healthy Health Care Worker Patient Transmission Aging Dietary Supplement: PreserVision AREDS formulation soft gels or tablets Dietary Supplement: Multivitamin with 11mg of zinc Not Applicable

Detailed Description:
This is a two-cohort prospective randomized study intended to test the role of Zinc versus multivitamin supplementation in supporting immune health in the setting of the COVID-19 pandemic. Individuals over 50 years old or primary health care professionals over the age of 18 who have had no evidence of prior COVID-19 infection and who have been asymptomatic for 7 days prior to enrollment will be randomized at the individual level to take either PreserVision AREDS formulation soft gels or tablets with 69.6mg/day Zinc supplementation or to receive a multivitamin supplement with 11mg of zinc/day.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study
Actual Study Start Date : September 28, 2020
Actual Primary Completion Date : May 28, 2021
Actual Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: High dose Zinc (PreserVision AREDS formulation soft gels or tablets)
Subjects will have a high dose Zinc supplementation in combination with Copper, Vitamin C/E and beta-carotene
 Dietary Supplement: PreserVision AREDS formulation soft gels or tablets
Two tabs taken daily for three months
Active Comparator: Multivitamin with 11mg of zinc
Subjects in this arm will have a multivitamin supplement with 11mg of zinc
 Dietary Supplement: Multivitamin with 11mg of zinc
One tab taken daily for three months


Outcome Measures
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Primary Outcome Measures :
  1. COVID-19 illness requiring hospitalization [ Time Frame: Through study completion, approximately 3 months ]
    Total number of subjects admitted to the hospital in relations to COVID-19 illness PCR or undergo seroconversion


Secondary Outcome Measures :
  1. Illness without hospitalization [ Time Frame: Through study completion, approximately 3 months ]
    Total number of subjects with COVID-19 illness that are not hospitalized

  2. Supplemental oxygen therapy during hospitalization [ Time Frame: Through study completion, approximately 3 months ]
    Total number of subjects to require supplemental oxygen therapy during hospitalization for COVID-19

  3. Invasive ventilation during hospitalization [ Time Frame: Through study completion, approximately 3 months ]
    Total number of subjects to require invasive ventilation during hospitalization for COVID-19

  4. Mortality [ Time Frame: Through study completion, approximately 3 months ]
    Total number of subject deaths


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥50 years old OR primary healthcare professional (defined as having a job that has had direct patient contact during the COVID-19 pandemic) and ≥18 years old
  • No symptoms of COVID-19 (a fever of 100.0o F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation) in the past 7 days
  • Have a negative Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening
  • Have not had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 without full PPE (Close contact is defined by CDC as: Being within approximately 6 feet of a COVID-19 patient for a total of 15 minutes or more over a 24 hour period) or having direct contact with infectious secretions of a COVID-19 patient (e.g. being coughed on)) in the last 14 days
  • Mayo Clinic patient who has a patient online account set up or is willing to set up an online account
  • Must have a valid email address and internet service

Exclusion Criteria:

  • History of positive or indeterminate COVID PCR test prior to screening or Elecsys Anti-SARS-CoV-2 immunoassay antibody test positive or indeterminate at screening
  • Active symptoms of COVID ((a fever of 100.0o F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation)) in past 7 days
  • Known intolerance to multivitamins or zinc supplements from prior exposure
  • Inability to complete follow-up questions or grant access to electronic health record for surveillance
  • Have had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 in past 14 days
  • Current or former smoker less than 5 years ago
  • Pregnant or breastfeeding
  • Prisoner

  • Any subject with known immunosuppressed state, including

    1. A history of solid organ or bone marrow transplantation
    2. Subjects currently receiving chemotherapy
    3. Current rheumatologic or autoimmune illness requiring treatment with glucocorticoids, antimetabolite agents (methotrexate, azathioprine, mercaptopurine, fluorouracil, mycophenolate, leflunomide), IMIDs (lenalidomide, thalidomide, pomalidomide), calcineurin inhibitors (tacrolimus, cyclosporine), mTOR inhibitors (sirolimus, everolimus), or any monoclonal antibody drugs (including any drug given intravenously or subcutaneously) for the purpose of immunosuppression
    4. Subjects with HIV or primary immunodeficiency syndromes
Contacts and Locations
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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): NCT04551339


Locations
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United States, Arizona
Mayo Clinic in Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Atta Behfar, MD, PhD Mayo Clinic
Principal Investigator: Albert Hakaim, MD Mayo Clinic
Principal Investigator: Ayan Sen, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Atta Behfar, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04551339    
Other Study ID Numbers: 20-004637
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atta Behfar, Mayo Clinic:
Zinc
Immune health