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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

Tracking Information
First Submitted Date  ICMJE September 9, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date August 10, 2021
Actual Study Start Date  ICMJE September 28, 2020
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Illness without hospitalization [ Time Frame: Through study completion, approximately 3 months ]
    Total number of subjects with COVID-19 illness that are not hospitalized
  • 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
  • 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
  • Mortality [ Time Frame: Through study completion, approximately 3 months ]
    Total number of subject deaths
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
Official Title  ICMJE Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Healthy
  • Health Care Worker Patient Transmission
  • Aging
Intervention  ICMJE
  • Dietary Supplement: PreserVision AREDS formulation soft gels or tablets
    Two tabs taken daily for three months
  • Dietary Supplement: Multivitamin with 11mg of zinc
    One tab taken daily for three months
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: PreserVision AREDS formulation soft gels or tablets
  • Active Comparator: Multivitamin with 11mg of zinc
    Subjects in this arm will have a multivitamin supplement with 11mg of zinc
    Intervention: Dietary Supplement: Multivitamin with 11mg of zinc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2021)
2700
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
4500
Actual Study Completion Date  ICMJE May 28, 2021
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04551339
Other Study ID Numbers  ICMJE 20-004637
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atta Behfar, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Atta Behfar, MD, PhD Mayo Clinic
Principal Investigator: Albert Hakaim, MD Mayo Clinic
Principal Investigator: Ayan Sen, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP