Safety and Efficacy of Fludrocortisone Addition to Dexamethasone in the Management of Hospitalised COVID-19 Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time to recovery
研究概览
简要总结
There is a considerable variability in aldosterone levels between individuals, and this may explain the wide variability in disease severity among those infected so we designed a pilot study to test for the safety and efficacy of fludrocortisone addition to standard of care in hospitalised COVID-19 patients.
详细描述
Many studies have shown involvement of renin-angiotensin-aldosterone system (RAAS) in pathophysiology of COVID-19. There is a considerable variability between people infected with SARS-COV-2 virus in terms of severity. At pathophysiological level there are variable degrees of increased capillary permeability with resultant fluid leak. We hypothesize that the physiological response to overcome this fluid leak mainly involves stimulation of mineralocorticoid (aldosterone) pathway. Hence; those with defective mineralocorticoid response are at high risk for disease complications.
Aldosterone secretion capacity is affected by many factors whether physiological (age, sex, ethnicity and pregnancy) or pathological (e.g. smoking); this is reflected in wide differences (regarding aldosterone levels) between groups of people depending on these factors.
These variations in mineralocorticoid capacity between groups of people may explain why some certain groups are at high risk for severe disease while others are at a lower risk.
So we designed this pilot study to assess safety and efficacy of mineralocorticoid, in the form of fludrocortisone, as a potential treatment for COVID-19 by its addition to dexamethasone in hospitalized COVID-19 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and non-pregnant female patients 18 years of age or older
- •Diagnosed with COVID-19 pneumonia as per local guidelines
- •Oxygen saturation (SaO2) of 93 % or less while they were breathing ambient air.
排除标准
- •A physician decision that involvement in the trial will not be in the patient's best interest, presence of any condition that would not allow the protocol to be followed safely.
- •known allergy or hypersensitivity to fludrocortisone.
- •known severe liver or kidney disease, uncontrolled hypertension, diabetes mellitus and peptic ulcer disease.
- •Hypokalemia (serum potassium of less than 3.5 mEq/L)
- •Use of medications that are contraindicated with fludrocortisone and that could not be replaced or stopped during the trial period.
研究组 & 干预措施
Fludrocortisone arm
10 hospitalised COVID-19 patients meeting inclusion criteria will receive fludrocortisone 0.1 mg tablets in addition to dexamethasone 6 mg / 24 hours and standard care
干预措施: Fludrocortisone Acetate 0.1 MG (Drug)
结局指标
主要结局
Time to recovery
时间窗: 28 days
The first day, during the 28 days after enrollment, on which a patient met the criteria for category 1 or 2 on the eight-category ordinal scale
次要结局
- Mortality Rate(28 days)
- Length of hospital stay(28 days)
- Rate of ICU admission(28 days)
- Mechanical ventilation need(28 days)
- Improvement of lymphopenia(7 days)
- Duration of Increased Supplemental Oxygen(28 days)