Outpatient, Liquid Aspirin to Reduce COVID-19 Hospitalizations
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduced COVID-19 related hospitalizations
研究概览
简要总结
The purpose of this study is to obtain reliable and interpretable data to inform future trials regarding our hypothesis that a novel, liquid aspirin formulation can mitigate COVID -19 associated coagulopathy (CAC) . The potential impact is to reduce COVID-19 related hospitalization within 30 days of diagnosis due to (1) pulmonary events including respiratory failure; (2) cardiac events including myocardial infarction and myocarditis (3) venous or arterial thrombotic events; (4) acute renal insufficiency or failure.
详细描述
200 people will take part in this LSUHSC-NO and its affiliates study.
The clinical site will offer study enrollment to newly diagnosed COVID-19 patients at the time of diagnosis. Contact information will be shared with study team in a HIPAA compliant manner on the same day. Within 24 hours, our Study staff will contact patient for recruitment and enrollment. Within 48 hours of enrollment, the patient will come to a study site for randomization to treatment arms, to be provided a no-cost supply of the treatment which they are assigned, and for blood draws that help determine their risk of developing severe COVID disease. Patients will be assigned to either:
Arm 1: Placebo
Or
Arm 2: Treatment with liquid aspirin 150 mg daily. (ASA 150).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Placebo and ASA 150 will be labeled to maintain blinding. The Principal Investigator and one Biostatistician will remain blinded to prevent any bias. Study staff/healthcare providers distributing the treatments to study subjects will be blinded to treatment assignment. Subjects will also be blinded to their treatment assignment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 40 years
- •Written informed consent
- •New (within 24 hours) COVID-19 diagnosis
- •Serum 25OHD levels drawn at time of COVID-19 laboratory workup
排除标准
- •Asymptomatic patients
- •Patients already taking ASA and other anti-coagulant / anti-platelet therapies including but not limited to clopidogrel, heparin, low molecular weight heparin, coumadin, apixaban.
- •Pregnant patients or prisoners
- •History of GI bleeding or peptic ulcer disease, or spontaneous bleeding from other sites
- •Thrombocytopenia (platelets <130,000/uL) at time of COVID diagnosis
- •Anemia at time of COVID diagnosis (defined as hemoglobin level <12 g/dl in men or <11 g/dl in women)22
- •History of chronic kidney disease
- •Concurrent use of nonsteroidal anti-inflammatory drugs, or steroids
- •Hypervitaminosis D and associated risk factors: Renal failure, Liver failure, Hyperparathyroidism, Sarcoidosis, Histoplasmosis
- •Known allergy to Aspirin
- •Inability to tolerate oral medications
- •Known history of aspirin-induced asthma
- •History of bleeding problems
- •Patients who cannot avoid drinking 3 or more alcoholic drinks every day during the 30-day course of ASA treatment
- •Patients who cannot stop taking other nonprescription NSAIDs (ibuprofen, naproxen, or others) during the 30-day course of ASA treatment
- •Patients requiring hospitalization (for any reason) at time of screening
- •Patients taking or who plan to take on an outpatient basis remdisivir, dexamethasone, or other therapies for treatment of COVID
研究组 & 干预措施
Placebo
Soy Bean Oil identical packaging as the active arm, taken once daily by mouth for 30 days.
干预措施: ASA (Drug)
Liquid ASA
Aspirin 150 mg liquid formulation (2.5%w/w) taken once daily by mouth for 30 days
干预措施: ASA (Drug)
结局指标
主要结局
Reduced COVID-19 related hospitalizations
时间窗: 6 months
To obtain reliable and interpretable data to inform future trials regarding our hypothesis that a 30 day treatment course of COVID patients with a novel, liquid aspirin formulation can reduce hospitalizations driven by COVID associate coagulopathy (CAC)
次要结局
未报告次要终点