A Randomized Controlled Trial to Evaluate the Outcomes With Aggrenox in Patients With SARS-CoV-2 Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Covid (Coronavirus Disease-19) Ordinal Scale
研究概览
简要总结
The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2 infection with symptoms consistent with COVID-19. An anticipated total of 132 participants will be randomly divided almost equally into 2 groups: one group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and laboratory outcomes of all the participants enrolled in the study will be evaluated at the end of the study to explore if there is any difference in the outcomes between 2 groups.
详细描述
Purpose/Specific Aims: The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2 infection with symptoms consistent with COVID-19.
Among 132 SARS-CoV-2 patients (66 patients in each randomized arm), we will determine the efficacy of Aggrenox on clinical outcomes.
Hypotheses / Research Question(s) Compared to standard care, the addition of Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg), to standard care will result in improvement in the composite COVID ordinal scale at day 15. Additionally, combined Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), and standard care will reduce the need for ventilation, length of mechanical ventilation, hospital length of stay, ICU length of stay, decrease risk of thromboembolic complications and improve survival more than standard care alone in SARS-CoV-2 patients.
Research Design and Methods Randomized design. Participants will be randomized 1:1 to Aggrenox or standard treatment. Arm 1: Active Comparator: (Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally).
Participants will receive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily (FDA-recommended dose) starting on the day of enrollment for a total of 2 weeks + standard care.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Hospitalization.
- •SARS-CoV-2 viral nucleic acid positive within 3 days.
- •Lab test result pending plus a high clinical suspicion for SARS-CoV-2 (fever and cough for ≤ 7 days, bilateral pulmonary infiltrates on imaging or new hypoxemia with spO2 ≤94% on room air or no alternative explanation for respiratory symptoms).
- •Willing and able to provide consent or by authorized proxy.
排除标准
- •G-6PD deficiency.
- •Use of antiplatelet agents including inhibitor of P2Y12 ADP platelet receptors, phosphodiesterase inhibitors, and Glycoprotein IIB/IIIA inhibitors.
- •On therapeutic anticoagulation with coumadin, heparin and direct oral anticoagulants.
- •Vasodilatory shock.
- •Patient with known ongoing angina, recent myocardial infarction and sub-valvular aortic stenosis.
- •Active gastric or duodenal ulcer or any bleeding disorder.
- •Hemoglobin <9 mg/dL, platelet count of <30,000 /mm
- •Acute respiratory infection for >10 days.
- •Known allergy/hypersensitivity to Dipyridamole and/or Aspirin.
- •Severe hepatic or renal insufficiency.
- •Uncontrolled hypertension defined as systolic > 180 mm Hg or diastolic > 100 mm Hg.
- •Patients with known allergy to NSAIDs
研究组 & 干预措施
Participants receiving Dipyridamole and Aspirin
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
干预措施: Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care (Drug)
Participants receiving Dipyridamole and Aspirin
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
干预措施: Standard of care (Other)
Participants receiving standard of care
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks. Standard of care treatment consist of an intravenous Remidesivir 200 mg loading dose and then 100 mg/daily for a total of 4 days for non-intubated patients and 10 days for intubated patients, intravenous/oral decadron 6 mg/daily for 10 days and prophylactic subcutaneous LMWH daily, started on the day of enrollment and for the duration of hospitalization. If the patients are discharged before 10 days, they are prescribed oral decadron 6 mg daily to complete the course of 10 days.
干预措施: Standard of care (Other)
结局指标
主要结局
Covid (Coronavirus Disease-19) Ordinal Scale
时间窗: 15 days
Change in composite COVID ordinal scale from day 1 to 14. Ordinal scale: 1) not hospitalized with resumption of normal activities; 2) not hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen; 4) hospitalized, requiring oxygen; 5) hospitalized, requiring high-flow oxygen therapy, or noninvasive ventilation; 6) hospitalized, requiring invasive ventilation; 7) ventilation plus additional organ support such as pressors, renal replacement therapy and ECMO and 8) death. COVID Ordinal Scale ranges from 1 to 8, with score 1 on the scale corresponds to an ambulatory patient with minimal symptoms and score 8 on the scale corresponds to death.
次要结局
- Inflammatory Marker(Baseline and 7 days)
- COVID Ordinal Scale(28 days)
- ICU Stay(28 days)
- Number of Participants Not Requiring Supplemental Oxygen(28 days)
- Invasive-ventilator(28 days)
- Mortality(28 days)
- Inflammatory Marker Between Baseline and 7 Days(Baseline and 7 days)
研究者
Amit Singla, MD, FAANS
Assistant Professor
Rutgers, The State University of New Jersey