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

Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Aging; Health Care Worker Patient Transmission
• Intervention / Treatment: Dietary supplement: PreserVision AREDS formulation soft gels or tablets; Dietary supplement: Multivitamin with 11mg of zinc

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: Interventional
• Enrollment (Actual): 2700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Scottsdale
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Jacksonville
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 illness requiring hospitalization	Total number of subjects admitted to the hospital in relations to COVID-19 illness PCR or undergo seroconversion	Through study completion, approximately 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illness without hospitalization	Total number of subjects with COVID-19 illness that are not hospitalized	Through study completion, approximately 3 months
Supplemental oxygen therapy during hospitalization	Total number of subjects to require supplemental oxygen therapy during hospitalization for COVID-19	Through study completion, approximately 3 months
Invasive ventilation during hospitalization	Total number of subjects to require invasive ventilation during hospitalization for COVID-19	Through study completion, approximately 3 months
Mortality	Total number of subject deaths	Through study completion, approximately 3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Atta Behfar, MD, PhD, Mayo Clinic; Principal Investigator: Albert Hakaim, MD, Mayo Clinic; Principal Investigator: Ayan Sen, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 7, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Zinc; Immune health
• Other Study ID Numbers: 20-004637

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No