The Role of Resistant Starch in COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3)
研究概览
简要总结
This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.
详细描述
The COVID-19 pandemic has caused a substantial strain on the healthcare system, with at least 14% of infected patients requiring hospitalization. Identifying ways to ameliorate the progression and severity of the COVID-19 infection and preventing hospitalization is critical. Patients suffering from COVID-19 have been shown to have a significant inflammatory response resembling that of cytokine release syndrome, and it is this inflammatory phase that is thought to drive fatality.
To this end, a multi-center randomized clinical trial to determine the efficacy of resistant starch in reducing the need for hospitalization for COVID-19 positive patients will be studied. This study will enroll 1500 non-hospitalized COVID-19 positive individuals who are being monitored in the outpatient setting. Patients will be randomized to either a dietary supplement containing resistant starch or a placebo for 14 days. Our primary outcome is the rate of hospitalization for COVID-19 related complications. Secondary outcomes will look at time to recovery and symptom severity scores.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •greater than 18 years of age
- •COVID-positive status
- •Being monitored in an outpatient setting at one of our study sites:
- •Yale New Haven Hospital (YNHH)
- •University of Michigan
- •University of Minnesota
排除标准
- •inflammatory bowel disease
- •history of gastric bypass surgery
- •active Clostridium difficile infection
- •active participation in another COVID-19 interventional trial
- •any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with the protocol procedures.
- •Reported allergy to starch
- •Difficulty swallowing in order to prevent any aspiration risk
- •Currently taking any IL-6 inhibitors such as Tocilizumab for any disease condition
研究组 & 干预措施
Intervention
Subjects will receive a dietary supplement containing resistant starch and be instructed to take 2 tablespoons (~20 grams) twice daily for 14 days. Initially subjects will take 2 tablespoons once daily for the first three days prior to increasing to 2 tablespoons twice daily.
干预措施: Dietary Supplement containing resistant starch (Drug)
Control
Subjects will receive a placebo starch, consisting of non resistant starch and be instructed to take 2 tablespoons (~ 20 grams) twice daily for 14 days. Initially subjects will take 2 tablespoons once daily for the first three days.
干预措施: Placebo Starch (Dietary Supplement)
结局指标
主要结局
Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3)
时间窗: One month from the start of treatment
Hospitalization for a COVID-19 related admission during the first month of follow up. Death prior to hospitalization thought to be secondary to COVID-19 will also be defined as an event.
次要结局
- Time to Clinical Recovery (TTCR) (Phase 2)(One month from the start of treatment, up to 4 months)
- Peak Symptom Severity Score (Phase 2)(One month from the start of treatment, up to 4 months)
研究者
Sherry Mansour
Instructor of Medicine
Yale University