Evaluation of Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of covid19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- ICU-treated Patients After 2-week Treatment
研究概览
简要总结
The associated use of Ivermectin, aspirin, dexamethasone, and enoxaparin (in different combinations and doses) will reduce the impact of COVID infection 19, the need of admission to the intensive care unit, and mortality.
详细描述
Between 30 and 50% of patients who contract COVID 19 will be asymptomatic or oligosymptomatic. This fact will not give rise to the consult, and will directly affect a notorious sub-registration of the cases.
The second, even more disturbing, premise is that these patients are as contagious as the moderate and severe cases.
The virus incubation period has been calculated at 5.1 days (95% CI, 4.5 to 5.8 days), and 97.5% of patients are said to have symptoms at 11 days (95% CI 8.2 to 15.6 days).
A mortality of 5.7% has been calculated. The average COVID patient presents with fever (78%), cough (60-79%) and myalgias or fatigue (35.8 to 44%).
55% develop dyspnea, which appears on average 8 days after the onset of symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with positive oral/nasal swabs
排除标准
- •Children under 5 years old Pregnant women Previous reports of allergy to any of the drugs used in the clinical trial
研究组 & 干预措施
Mild cases
This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms such as: fever not above 38.5 °C; isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (93 - 96 %), dyspnea without matter, polymyoarthralgias, persistent headache, abdominal pain.
干预措施: Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets (Drug)
Moderate cases
This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting either: 3 severe symptoms (i.e. fever above 38.5 °C, diarrhea with more than 3 daily depositions, flictenular conjunctivitis, strong desaturation (92% or less), tachypnea (FR> 25 / minute) or 2 severe symptoms + 2 mild symptoms (fever not above 38.5 °C; isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (93 - 96 %), dyspnea without matter, polymyoarthralgias, persistent headache, abdominal pain)
干预措施: Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets (Other)
Severe cases
This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting either: 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms or clinical signs of bilateral viral pneumonia
干预措施: Ivermectin 5 MG/ML oral solution, Dexamethasone 4-mg injection, Enoxaparin injection. Inpatient treatment with mechanical ventilation in ICU. (Other)
结局指标
主要结局
ICU-treated Patients After 2-week Treatment
时间窗: 14 days
Number of patients needing ICU-treatment including mechanical ventilation after 2-week treatment
Patients Needing Drug Dose Adjustment
时间窗: 14 days
Patients who needed dose adjustment of any of the drugs involved in the treatment protocol
Patients Who Improved Their Condition or Did Not Worsen it
时间窗: 7 days
Number of patients who did not go to a more severe stage of disease or die (i.e. they neither go from mild to moderate or severe, nor go from moderate to severe or die, if they had been already enrolled in a severe condition)
Mortality
时间窗: 30 days
Patients who died within 30 days after enrollment
Adverse Events
时间窗: 14 days
Patient presenting serious adverse events
次要结局
未报告次要终点
研究者
Hector E Carvallo
Principal investigator
Eurnekian Public Hospital