NCT04551339已完成不适用
Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 2,700
- 试验地点
- 6
- 主要终点
- COVID-19 illness requiring hospitalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
COVID-19 illness requiring hospitalization
时间窗: Through study completion, approximately 3 months
Total number of subjects admitted to the hospital in relations to COVID-19 illness PCR or undergo seroconversion
次要结局
- Illness without hospitalization(Through study completion, approximately 3 months)
- Mortality(Through study completion, approximately 3 months)
- Supplemental oxygen therapy during hospitalization(Through study completion, approximately 3 months)
- Invasive ventilation during hospitalization(Through study completion, approximately 3 months)
研究者
研究点 (6)
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