Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Virology Cure Rate
研究概览
简要总结
This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.
详细描述
This is an open-label, non-randomized study to evaluate anti-malarial/anti-infective single-agents and combination therapies for patients with confirmed COVID-19 infection requiring therapy as determined by risk factors for complication (age, comorbid illness) or the presence of respiratory compromise. The first combination to be evaluated is atovaquone/azithromycin. Other combinations may be added to the study at future amendments as information of potential benefit arises. The first part of the study will enroll 25 evaluable male and female patients 18 years of age or older with confirmed COVID-19 infection.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients age 18 years or older
- •COVID-19 confirmed positive test results
- •High risk for complications including with Medium (5-6) or High (More than or equal to 7) NEWS score
- •Hematology criteria: ANC >500 cells/mcl, HGB >9 g/dl, Platelet count >75,000/mcl
- •Metabolic criteria: Serum creatinine <2.0 mg/dl or calculated creatinine clearance (using Cockcroft-Gault) >30 ml/min, AST/ALT <5x ULN AND Total Bilirubin WNL (for patients with Gilbert's disease, direct bilirubin <ULN)
排除标准
- •COVID-19 negative test result
- •Inability to adhere to study protocol requirements
- •Inability to provide informed consent
- •Other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study
- •Pregnant and breastfeeding individuals
- •QTc interval greater than 470 msecs at baseline
- •History of hypersensitivity to atovaquone and/or azithromycin.
- •History of known intolerance to atovaquone and/or azithromycin
研究组 & 干预措施
Atovaquone/Azithromycin
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
干预措施: Atovaquone/Azithromycin (Drug)
结局指标
主要结局
Virology Cure Rate
时间窗: 10 days
Virology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing.
次要结局
- Incidence of GI adverse events(47 days)
- Cardiac Toxicity(10 days)
- Incidence of Gastrointestinal Adverse Events(47 days)