Azithromycin With Amoxicillin/Clavulanate Versus Amoxicillin/Clavulanate Alone in COVID-19 Patients With Pneumonia and Hospitalized in a Non-intensive Care Unit Ward (AziA): a Superiority Open-label Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Rate of positive SARS-CoV-2 RT-PCR
研究概览
简要总结
The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. A recent open-label nonrandomized French study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). Azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. Our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at Day 6 in COVID-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 ans,
- •Patient with positive SARS-CoV-2 RT-PCR on nasopharyngeal sample at randomization or within the previous 48 hours,
- •Patient with pneumonia diagnosed by thorax CT-scan or echography,
- •Patient able to take per os medication,
- •Written and signed consent of the patient,
- •Patients affiliated with or benefitting from a social security scheme.
排除标准
- •Patient hospitalized in intensive care unit,
- •Patient who received more than 24 hours of antibiotic treatment for the ongoing episode,
- •Chronic renal failure with a Glomerular Filtration Rate < 20ml/min,
- •Severe hepatic failure,
- •Severe chronic cardiac insufficiency,
- •Allergy to macrolides,
- •Electrocardiogram showing corrected QT prolongation greater than 470 ms in men and 480 ms in women.
- •Life-threatening presentation expected to lead to possible imminent death (based on provider assessment)
研究组 & 干预措施
Azithromycin with amoxicillin/clavulanate
Combination of azithromycin during 4 days with amoxicillin/clavulanate during 7 days.
干预措施: Azithromycin with amoxicillin/clavulanate (Combination Product)
Amoxicillin/clavulanate
Amoxicillin/clavulanate every day during 7 days.
干预措施: amoxicillin/clavulanate (Drug)
结局指标
主要结局
Rate of positive SARS-CoV-2 RT-PCR
时间窗: Day 6
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal sample
次要结局
- Number of all-cause mortality during the 30 days following inclusion(30 days)
- Number of in-hospital mortality during the 30 days following inclusion(30 days)
- Number of patients transferred to intensive care unit during the 30-day follow-up(30 days)
- Number of days without mechanical ventilation during the 30 days following inclusion(30 days)
- Rate of positive SARS-CoV-2 RT-PCR(Day 10)
- Clinical evolution on the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19(day 6, day 10, and day 30)
- Total duration of antibiotic treatment during the 30 days following inclusion(30 days)
- adverse events attributable to antibiotic treatment during the 30 days following inclusion(30 days)
- Hospital length of stay during the 30 days following inclusion(30 days)