Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Need of a high dose of oxygen or mechanical ventilation.
研究概览
简要总结
The recent inception of the coronavirus SARS-CoV-2, responsible for the coronavirus disease (COVID-19), has caused thousands of deaths globally. The most frequently reported complications among COVID-19 patients are from respiratory involvement.
Vitamin D has immunomodulatory effects that could protect against COVID-19 infection. Indeed, there is good evidence from randomized clinical trials suggesting that high doses of vitamin D administered during cold seasons prevent viral respiratory infections in at risk individual, and more recently, observational studies suggested that the mortality rate from COVID-19 is inversely correlated with levels of serum 25(OH)vitamin D.
The hypothesis of the study is that a high dose of vitamin D given orally to patients admitted to the hospital for COVID-19 will prevent the occurrence of respiratory deragement and other adverse clinical events.
To evaluate the aforementioned hypothesis, a randomized, controlled, double-blind, clinical trial comparing a 500.000 UI dose of vitamin D versus placebo among COVID-19 patients at moderate risk, requiring hospitalization but without requirements of critical care at admission was designed. The intervention will be one dose of 500.000 UI given orally or matching placebo.
The trial has a sequential design with two steps:
- The first step, projected to include 200 patients, will assess the effects of the intervention on the respiratory SOFA; and
- If there is a detectable effects, the second step, projected to include 1264 patients, will assess the effects on a combined event that includes need of high dose of oxygen or mechanical ventilation.
All study outcomes will be measured during the index hospitalization.
详细描述
See above.
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)
盲法说明
The study will use a placebo identical to the active medication. The members of research team assessing the outcomes will not be aware of the treatment assignment.
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
- •SARS-CoV-2 confirmed infection;
- •Admission to a hospital;
- •Expected hospitalization in the center for at least for 24 hs;
- •Oxygen Saturation >90% breathing without oxygen supplement;
- •Age at least 45 years or the presence of one of the followings risk factors:
- •Hypertension;
- •Diabetes (type I o II);
- •At least moderate COPD or Asthma;
- •Cardiovascular disease (history of myocardial infarction, coronary angioplasty, coronary artery bypass grafting or valve replacement surgery);
- •Body Mass Index >=30;
- •Signed Written consent.
排除标准
- •<18 years old;
- •Women in childbearing age;
- •>= 72 hs since current admission;
- •Requirement for high dose of oxygen (>5 liters/minute) or mechanical ventilation (non-invasive or invasive);
- •History of Chronic kidney disease requiring hemodialysis or chronic liver failure;
- •Inability for oral intake;
- •Previous treatment with pharmacological vitamin D;
- •History of:
- •previous treatment with anticonvulsants;
- •sarcoidosis;
- •malabsorption syndrome;
- •Known hypercalcemia.
- •Life expectancy less than 6 months;
- •Known allergy to the study medication;
- •Any condition impeding to bring informed consent.
研究组 & 干预措施
Vitamin D
5 capsules containing 100.000 UI of vitamin D each. The intervention will be 5 capsules given in one-time oral intake.
干预措施: Vitamin D (Drug)
Placebo
5 capsules containing placebo. The intervention will be 5 capsules given in one-time oral intake.
干预措施: Placebo (Drug)
结局指标
主要结局
Need of a high dose of oxygen or mechanical ventilation.
时间窗: 30 days
The start of oxygen supplementation at FiO2 \>40% or the initiation of invasive through orotracheal intubation) or non-invasive ventilation (Continuous positive airway pressure or Bilevel positive airway ventilation). This outcome will be recorded during hospitalization to 30 days, the death or discharge, whichever occur first. This is the primary outcome of the second study phase.
Respiratory SOFA.
时间窗: One week
Is the respiratory component of the sequential organ failure assessment score (SOFA score). It is a 4 points scale, each point indicate a deeper respiratory impairment. The score is based on the relationship between the arterial pressure of oxygen (PaO2) and inspired fraction of oxygen (FiO2), as the ratio of both (PaFi). In the cases were arterial blood gas are not measured, the pulse oximetry will be used instead. The respiratory SOFA is as follows: * 1: PaO2/FiO2 \>=300; * 2: PaO2/FiO2 \>=200 and \<300; * 3: PaO2/FiO2 \>=100 and \<200; * 4: PaO2/FiO2 \<100. The minimum respiratory SOFA score will be record on daily basis during first week or to death or discharge, whichever occur first. This outcome is the primary outcome of the first study phase.
次要结局
- Death(30 days.)
- Oxygen desaturation.(One week)
- Change in oxygen saturation.(One week)
- ICU length of stay.(30 days)
- Change in Quick SOFA score.(30 days.)
- Myocardial infarction.(30 days)
- Stroke.(30 days)
- Acute kidney injury.(30 days)
- Pulmonary thromboembolism.(30 days)
- Combined endpoint (stroke, myocardial infarction, acute kidney injury and pulmonary thromboembolism.(30 days)
- Admission to ICU.(30 days)
- Invasive Mechanical Ventilation.(30 days)
- Hospital Length of Stay.(30 days.)