An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects Positive With SARS-CoV-2 With Mild Symptoms
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Improvement of clinical status
研究概览
简要总结
Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona.
This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2
详细描述
COVID-19 has become a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%); therefore, interventions to decrease the incidence and severity of COVID-19 are emergently needed. In Maricopa County there has yet to be a clinical trial to evaluate people who are SARS-CoV-2 positive with mild symptoms. This study will measure the improvement of COVID-19 disease status as measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free on 14 days of a cocktail therapy of Hydroxychloroquine, Indomethacin and Zithromax.
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
盲法说明
Open Label
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
- •> 18 years of age
- •Willing and able to provide written informed consent prior to performing study procedures
- •Confirmed Sars-CoV2 infection by PCR
- •Have mild symptoms of Sars-CoV2
- •Must show documentation of Sars-CoV2 to screening visit
- •Must have had recent hematology and chemistry results
- •Must be able to take heart rate daily
- •Must agree to Skype/Facetime daily
- •Must agree to take temperature daily
- •Must agree not to enroll in another study of an investigational agent prior to completion of Day 14 of treatment.
排除标准
- •Known to be allergic to research drugs or drug excipients
- •Incapable of providing informed consent
- •Participation in any other clinical trial of an experimental treatment for Sars-CoV2 infection
- •Pregnancy, possible pregnancy or breast feeding
- •Prolonged QT interval (>450)
- •Moderate to severe symptoms of Sars-CoV2
- •Renal failure
- •Hepatic failure
结局指标
主要结局
Improvement of clinical status
时间窗: up to 28 days
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free
次要结局
- Time of clinical recovery of cough(up to 28 days)
- Time of clinical recovery of fever(up to 15 days)
- Safety as determined by changes in QTC intervals measured by ECG(up to 15 days)
- Safety as determined by presence of side effects(up to 15 days)
- Time to improvement(up to 28 days)