HealthyZnCOVID-19NCT04551339
Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
A study testing PreserVision AREDS formulation soft gels or tablets and Multivitamin with 11mg of zinc in people with Healthy and Health Care Worker Patient Transmission, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Health Care Worker Patient Transmission, Aging
- What is being tested?
- PreserVision AREDS formulation soft gels or tablets and Multivitamin with 11mg of zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Sep 2020to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Pregnant or breastfeeding
- Prisoner
- Any subject with known immunosuppressed state, including
- A history of solid organ or bone marrow transplantation
- Subjects currently receiving chemotherapy
- 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
- Subjects with HIV or primary immunodeficiency syndromes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Scottsdale
Scottsdale, Arizona, 85259
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Health Care Worker Patient Transmission, Aging
- Being tested
- PreserVision AREDS formulation soft gels or tablets, Multivitamin with 11mg of zinc
- Keywords
- Zinc, Immune health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreserVision AREDS formulation soft gels or tabletsDietary supplement
Two tabs taken daily for three months
Multivitamin with 11mg of zincDietary supplement
One tab taken daily for three months
| Study group | Role | What they receive |
|---|---|---|
| High dose Zinc (PreserVision AREDS formulation soft gels or tablets) | Active comparator | Subjects will have a high dose Zinc supplementation in combination with Copper, Vitamin C/E and beta-carotene Receives: Dietary Supplement: PreserVision AREDS formulation soft gels or tablets |
| Multivitamin with 11mg of zinc | Active comparator | Subjects in this arm will have a multivitamin supplement with 11mg of zinc Receives: Dietary Supplement: Multivitamin with 11mg of zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 illness requiring hospitalization
Total number of subjects admitted to the hospital in relations to COVID-19 illness PCR or undergo seroconversion
Measured: Through study completion, approximately 3 months
Secondary outcomes (4)
Illness without hospitalization
Total number of subjects with COVID-19 illness that are not hospitalized
Measured: 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
Measured: Through study completion, approximately 3 months
Invasive ventilation during hospitalization
Total number of subjects to require invasive ventilation during hospitalization for COVID-19
Measured: Through study completion, approximately 3 months
Mortality
Total number of subject deaths
Measured: Through study completion, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start28 Sep 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atta Behfar, Mayo Clinic
- Investigators
- Atta Behfar, MD, PhD, Principal investigator, Mayo ClinicAlbert Hakaim, MD, Principal investigator, Mayo ClinicAyan Sen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551339
- Sponsor's protocol ID
- 20-004637
- Acronym
- ZnCOVID-19
- Status last verified
- Aug 2021
- First submitted
- 9 Sep 2020
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study
- ClinicalTrials.gov ID
- NCT04551339
- Acronym / sponsor ID
- ZnCOVID-19 / 20-004637
- Conditions
- Healthy, Health Care Worker Patient Transmission, Aging
- Keywords
- Zinc, Immune health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Zinc (PreserVision AREDS formulation soft gels or tablets) | Active comparator | Dietary Supplement: PreserVision AREDS formulation soft gels or tabletsSubjects will have a high dose Zinc supplementation in combination with Copper, Vitamin C/E and beta-carotene |
| Multivitamin with 11mg of zinc | Active comparator | Dietary Supplement: Multivitamin with 11mg of zincSubjects in this arm will have a multivitamin supplement with 11mg of zinc |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreserVision AREDS formulation soft gels or tabletsTwo tabs taken daily for three months | Dietary supplement | High dose Zinc (PreserVision AREDS formulation soft gels or tablets) |
| Multivitamin with 11mg of zincOne tab taken daily for three months | Dietary supplement | Multivitamin with 11mg of zinc |
Primary outcome
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
4 secondary outcomes
Illness without hospitalization
Time frame: Through study completion, approximately 3 months
Supplemental oxygen therapy during hospitalization
Time frame: Through study completion, approximately 3 months
Invasive ventilation during hospitalization
Time frame: Through study completion, approximately 3 months
Mortality
Time frame: Through study completion, approximately 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atta Behfar, MD, PhD principal investigator
Mayo Clinic
Albert Hakaim, MD principal investigator
Mayo Clinic
Ayan Sen, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PreserVision AREDS formulation soft gels or tablets and Multivitamin with 11mg of zinc in people with Healthy and Health Care Worker Patient Transmission, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 illness requiring hospitalization (time frame: Through study completion, approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.