Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Hospitalization Rates for COVID-19
研究概览
简要总结
Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. In this proof-of-concept pilot study we will compare the effects of resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
详细描述
This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus replication while separately published in silico (computer molecular docking analysis) reports have identified specific molecular targets of resveratrol against (Severe Acute Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that resveratrol is effective at preventing lung injury and death in certain animal models of viral infections. Furthermore, the products long history as an anti-inflammatory might prevent the cytokine storm that is associated with worse outcomes in COVID-19.
200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will be enrolled in study to compare whether taking resveratrol will reduce the rate of hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15 days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day. Placebo tablets will contain brown rice flour in visually identical capsules. The primary outcome measure for this trial is reduction in hospitalization at 21 days from enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients who test positive for infection with SARS-CoV-
- •Age ≥45 years
- •Mild COVID-19 based on World Health Organization (WHO) Baseline Severity Categorization
- •Symptom duration ≤ 10 days, or <72 hours of new respiratory symptoms.
- •Patient must have access to the internet or a smartphone to complete surveys.
- •English-speaking patients
排除标准
- •Diagnosed or suspected cognitive impairment that would prevent the patient from cooperating with study procedures, as judged by the screening clinician
- •Asymptomatic patients (e.g. patients who were screened without symptoms but tested positive)
- •Known or suspected liver disease or Hepatitis C
- •Known kidney disease with estimate Glomerular Filtration Rate (eGFR) <60
- •Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors, immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow therapeutic window.
- •Allergy to grapes or rice.
- •Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current cancer treatment, severe Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure (CHF))
- •Currently pregnant
- •Hospitalization
研究组 & 干预措施
Resveratrol with Vitamin D3
Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1
干预措施: Resveratrol (Drug)
Resveratrol with Vitamin D3
Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1
干预措施: Vitamin D3 (Dietary Supplement)
Placebo with Vitamin D3
Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Hospitalization Rates for COVID-19
时间窗: 21 days from study randomization
Number of study participants admitted to the hospital within 21 days of randomization
次要结局
- Invasive Ventilation Rates(21 days from randomization)
- Pneumonia(21 days from randomization)
- Pulmonary Embolism(21 days from start of randomization.)
- ICU Admission Rates(21 days from randomization)
- Death(Within 21 days from randomization)
研究者
Marvin McCreary, MD
Emergency Physician
Mount Carmel Health System