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

Mayo Clinic

Status

Completed

Conditions

Aging

Healthy

Health Care Worker Patient Transmission

Treatments

Dietary Supplement: Multivitamin with 11mg of zinc

Dietary Supplement: PreserVision AREDS formulation soft gels or tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT04551339

20-004637

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,700 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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