Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Number of Participants Who Were Symptom Free at Day 14
研究概览
简要总结
This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.
详细描述
Identification of a safe, effective treatment for individuals with mild or moderate COVID-19 that prevents disease progression and reduces hospitalization would reduce the burden on the health system. High dose hydroxychloroquine is being evaluated for SARS-CoV-2 prevention and COVID-19 disease treatment, but has a high risk of a number of potentially severe adverse events. Recent evidence has indicated that the broad-spectrum macrolide azithromycin may have some activity against coronaviruses. Here we propose an individually-randomized, placebo-controlled trial to determine the efficacy of a single dose of azithromycin for prevention of COVID-19.
Potential participants will undergo remote eligibility screening with study staff prior to enrollment. Upon determination of eligibility and signing electronic informed consent documents, participants will be emailed baseline study forms and will be mailed their randomized study treatment. At the end of the study (21 days), participants will be emailed a final study questionnaire. Note that there will no contact between study staff and participants in this trial, minimizing risk of infection spread.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Evidence of a positive SARS-CoV-2 test and test results received within the previous seven days
- •Not currently hospitalized
- •Willing and able to receive study drug by mail
- •Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone
- •No known allergy or other contraindication to macrolides
- •Age 18 years or older at the time of enrollment
- •No known history of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia)
- •No recent use of hydroxychloroquine within the past 7 days for participants >55 years of age
- •Not currently taking nelfinavir or warfarin (Coumadin)
- •Provision of informed consent
- •Not currently pregnant
排除标准
- 未提供
研究组 & 干预措施
Azithromycin
1.2g of oral azithromycin
干预措施: Azithromycin (Drug)
Placebo
Matching placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Number of Participants Who Were Symptom Free at Day 14
时间窗: 14 days
Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
次要结局
- Number of Participants With Emergency Room Visits(21 days)
- Adverse Events(3 days)
- Viral Load - Nasal Swab(3 days)
- Positive SARS-CoV-2 Test - Rectal Swab(3 days)
- Number of Household Members With COVID-19 (Confirmed or Symptomatic)(21 days)
- Number of Participants That Died(21 days)
- Positive SARS-CoV-2 Test - Nasal Swab(3 days)
- Genetic Macrolide Resistance Determinants(3 days)
- Secondary Outcomes Through Day 21(Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days))
- Number of Participants Reporting Hospitalization(21 Days)
- Viral Load - Saliva Swab(3 days)
- Mortality(14 days)
- Positive SARS-CoV-2 Test - Saliva Swab(3 days)
研究者
Thomas M. Lietman
Professor
University of California, San Francisco