Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19).
Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.
详细描述
Efficacy parameters to compare both groups (vitamin D and No vitamin D).
Time to reach undetectable levels of SARS COV2 Infection.
Time of normalization of symptoms and clinical parameters.
Time of normalization of radiological images.
Time of normalization of biochemical markers.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 year
- •Diagnosis of COVID-19
- •Accept to participate in the study ( consent)
排除标准
- •Pregnancy
- •Allergy to vitamin D
- •Consumption of any form of vitamin D during the last 3 months
- •Expected fatal outcome in the next 24 hours
- •Cognitive deterioration
研究组 & 干预措施
Active
Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Mortality
时间窗: Time to death or hospital discharge in days (average 12 days)
Percentage of patients dying during hospitalization
Admission to Intensive Care Unit (ICU)
时间窗: Time from hospital admission to discharge in days (average 12 days)
Percentage of patients admitted to ICU and time in ICU
Time of hospitalization
时间窗: Time of hospitalization in days (average 12 days)
Number of days from hospital admission to discharge
Radiological changes
时间窗: At the time of hospital admission and discharge (average 12 days)
Changes in the percentage of patients with radiological findings of pneumonia and severity
Calcidiol changes
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Calcidiol levels in ng/mL.
Inflammation markers changes (CRP)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
C-reactive protein (CRP) in mg/L
Inflammation markers changes (Leucocytes)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Leucocytes in cells per liter
General biochemical parameters changes (Ferritin)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Ferritin in µg/L
Clinical changes
时间窗: At the time of hospital admission and discharge (average 12 days)
Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...)
Inflammation markers changes (IL-6)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Interleukin-6 (IL-6) in pg/mL
Inflammation markers changes (D-dimer)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
D-dimer in µg/mL
General biochemical parameters changes (Creatinine)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Creatinine in mg/dL
General biochemical parameters changes (Bilirubin)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Bilirubin in mg/dL
General biochemical parameters changes (Albumin)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Albumin in g/dL
General biochemical parameters changes (Haemoglobin)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Haemoglobin in g/dL
General biochemical parameters changes (Procalcitonin)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Procalcitonin in ng/mL
General biochemical parameters changes (HDL cholesterol)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
High density lipoprotein (HDL cholesterol) in mg/dL
General biochemical parameters changes (Protonin)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Protonin in ng/L
General biochemical parameters changes (Calcium)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Calcium in mg/dL
General biochemical parameters changes (Phosphate)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Phosphate in mg/dL
General biochemical parameters changes (pO2)
时间窗: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
pO2 in mmHg
次要结局
未报告次要终点