Clinical trial NCT04551339: Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
Official title: Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Health Care Worker Patient Transmission
Aging
Keywords: Zinc
Immune health
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: COVID-19 illness requiring hospitalization
timeFrame: Through study completion, approximately 3 months
Secondary outcomes:
measure: Illness without hospitalization
timeFrame: Through study completion, approximately 3 months
measure: Supplemental oxygen therapy during hospitalization
timeFrame: Through study completion, approximately 3 months
measure: Invasive ventilation during hospitalization
timeFrame: Through study completion, approximately 3 months
measure: Mortality
timeFrame: Through study completion, approximately 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Scottsdale
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Jacksonville
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Atta Behfar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Albert Hakaim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Ayan Sen, MD
role: PRINCIPAL_INVESTIGATOR
References: