Can SARS-CoV-2 Viral Shedding in COVID-19 Disease be Reduced by Resveratrol-assisted Zinc Ingestion, a Direct Inhibitor of SARS-CoV-2-RNA Polymerase? A Single Blinded Phase II Protocol (Reszinate Trial)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Reduction in Severity of COVID-19 Disease
研究概览
简要总结
Administration of Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period in covid-19 positive patients in an outpatient setting
详细描述
Research Question: In ambulatory, non-hospitalized patients with SARS-CoV-2 infection, is it possible to utilize resveratrol as a transporter for zinc treatment as means to minimize viral load and severity of resulting COVID-19 disease?
60 ambulatory SARS-CoV-2 positive volunteers who will be randomized into one of two treatment arms to receive either Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period. It is anticipated to take approximately 20 weeks to accrue this cohort resulting in an estimated active project period of 22 weeks, although it may take up to 12 additional weeks to collect all of the data related to COVID-19 admissions in the cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
single blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 - 75) with a nasal swab confirmed SARS-CoV-2 infection; testing positive within 4 days of enrollment
- •Ability to read, understand and provide informed consent (no legally authorized representatives may consent on their behalf) and study assessments in English
- •Ability for subject to comply with the requirements of the study (must/will have a valid email address, internet connection and phone number)
- •Willingness to self limit medications and supplements and report what they are taking
- •Comfortable self-administering oral medication and nasal swab sampling
- •Willingness to permit a review of their medical history and to provide medical data from their electronic medical record for the period of enrollment (14 days) and until resolution of Covid-19 related events. Individuals who are not current Swedish patients will be asked to identify their provider of record and provide access to specific elements of their electronic health record.
- •Reside within twenty-five miles of one of the Swedish campuses: First Hill, Ballard, Edmonds, Issaquah, Cherry Hill.
排除标准
- •Reported history or evidence of impaired liver or kidney function: GFR <30 or bilirubin >2x ULT or INR > 2x ULT in the absence of anticoagulants
- •Known hypersensitivity to zinc or resveratrol
- •Diagnosis of COVID-19 or SARS-CoV-2 infection >4 days before enrollment
- •Preexisting severe pulmonary disease requiring supplemental oxygen
- •Clinically evident impairment of cognitive function, per physician discretion
- •Active substance abuse that may prevent the subject from completing the protocol requirements, per physician discretion.
- •Active psychotic or affective disorder that may prevent the subject from completing the protocol requirements, per physician discretion.
- •Pregnant or lactating females.
- •Coumadin treatment that can not be halted during the study period
结局指标
主要结局
Reduction in Severity of COVID-19 Disease
时间窗: 1 year
Review of healthcare resource utilization during study period
Reduction in SARS-CoV-2 Viral load
时间窗: 1 year
Viral AUCs normalized to peak viral load and housekeeper genes will be calculated, the AUCs on subjects with complete data will be used as dependent measures in t-tests, regressions and repeated measures mixed ANOVAs to compare viral load reduction between groups
次要结局
未报告次要终点