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

• ClinicalTrials.gov Identifier: NCT04551339
• Recruitment Status: Enrolling by invitation
• First Posted: September 16, 2020
• Last Update Posted: January 5, 2021
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Atta Behfar, Mayo Clinic

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 4500 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
• Estimated Primary Completion Date: June 14, 2021
• Estimated Study Completion Date: September 14, 2021

Arms and Interventions

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

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

• 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

Locations

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

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

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Atta Behfar, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04551339
• Other Study ID Numbers: 20-004637
• First Posted: September 16, 2020
• Last Update Posted: January 5, 2021
• Last Verified: December 2020

• 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