Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patients requiring admission to the hospital or experiencing death
研究概览
简要总结
To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Laboratory confirmed SARS-CoV-2 infection < 4 days before randomization
- •Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) <4 days before admission
- •Asymptomatic or mild symptoms (not requiring hospital admission)
- •Access to and ability to use a mobile phone with telehealth capability
排除标准
- •Unable to provide informed consent or comply with study directions
- •Admitted to an acute care bed
- •Baseline serum calcium < 8.8 mg/dL or > 10.2 mg/dl (as evaluated by labs taken in the ER/urgent care)
- •Women who are currently breastfeeding
- •History of kidney stone in the past year or h/o multiple (>1) previous kidney stones
- •Does not have a smart phone that can download apps from Google Play or App Store.
- •No way to keep the phone charged consistently
- •The smartphone is shared with another individual.
- •Required laboratory data is unavailable (eg calcium levels)
- •No new oxygen requirement (see remote monitoring document)
- •Pregnant and lactating mothers.
- •Vitamin D level of 80ng/ml and above
- •No lab work for calcium or vitamin D completed in ED
研究组 & 干预措施
Vitamin D
Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
干预措施: Vitamin D3 or Placebo (Drug)
Vitamin D
Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
干预措施: Doctella telehealth monitoring (Device)
Placebo
Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
干预措施: Doctella telehealth monitoring (Device)
结局指标
主要结局
Patients requiring admission to the hospital or experiencing death
时间窗: Days 1 to 15
Proportion of patients requiring admission to the hospital or experiencing death by Day 15
次要结局
未报告次要终点
研究者
Dr. Kevin Cooper
Principal Investigator
University Hospitals Cleveland Medical Center