Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Length of symptom duration (in days) with azithromycin treatment
研究概览
简要总结
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world.
To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted.
It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.
详细描述
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world.
To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted.
It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Treatment must be as safe as possible allowing a wide distribution to the symptomatic population while keeping a favorable risk/benefice balance for a patient with little symptoms.
Several studies show that azithromycin (AZM) has an anti-inflammatory effect. In patients with cystic fibrosis, AZM is known to have an anti-fibrotic effect by targeting myofibroblast cells, which considerably prolongs their lifespan. AZM acts functionally as an anti-inflammatory drug and reduces senescence associated secretory phenotype (SASP) mediators, such as IL-1beta and IL-632. AZM has also been shown to inhibit the replication of certain viruses, such as Zika and Ebola.
Therefore AZM is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases) Therefore, the prescription of AZM in COVID-19 + patients aims to increase the antiviral response locally at pulmonary level, while promoting a decrease in the immune response at systemic level.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated at the CHU Amiens Picardie presenting:
- •Age ≥18 years
- •Showing symptoms of COVID -19 and a positive RT-PCR by nasopharyngeal swab
- •Non-severe patient, outpatient (not hospitalized), without oxygen
- •Having signed a consent to participate in the study
排除标准
- •Patient with a contraindication to taking azithromycin, namely: Allergy to macrolides, Severe liver failure.
- •In combination with medicines containing cisapride, colchicine, ergotamine or dihydroergotamine
- •Pregnant, parturient or breastfeeding women.
- •Asymptomatic patients
- •Patient unable to be compliant with study protocol
- •Patient under guardianship or curators, under the protection of justice or private public law.
研究组 & 干预措施
azithromycin
azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
干预措施: consultation (Other)
azithromycin
azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
干预措施: Azithromycin (Drug)
symptomatic treatment
continuation of symptomatic treatment
干预措施: consultation (Other)
结局指标
主要结局
Length of symptom duration (in days) with azithromycin treatment
时间窗: up to 2 months
Length of symptom duration (in days) with azithromycin treatment
次要结局
未报告次要终点