A Randomized Trial of Efficacy and Safety of an Early OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome: a Strategy to Prevent Hospitalization
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Hospital admission
研究概览
简要总结
COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.
详细描述
The investigators make the hypothesis that an early outpatient treatment of COVID among patient with respiratory symptoms and risk factors for poor outcome can improve the prognosis of these patient and decrease the need for hospital admission.
Our study is an open label randomized clinical trial comparing 4 arms of treatment: Standards of Care (SoC) alone versus SoC + Azithromycine versus SoC + Hydroxychloroquine vs Soc + Lopinavir/Ritonavir.
Our involved population is patients more than 50 years of age with comorbidity or patients more than 70 years of age.
Our primary objective is to evaluate the efficacy of early outpatient treatment compared to standard of care in patients COVID-19 with risk factors for poor outcome. The criteria is hospital admission at Day 20 and the hospital admission rate will be compared between groups by a Chi² test or a Fisher's exact test.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either patients over 50 years of age with at least one comorbidity (hypertension, diabetes, obesity, cancer, chronic renal disease, immunodeficiency) OR patients over 70 years of age with or without comorbidity
- •Laboratory (PCR-) proved infection by COVID-19 or radiological sign highly suggestive of COVID-19
- •Respiratory symptoms (cough, chest discomfort, dyspnea)
- •Affiliation to the social security network
- •Able to understand and sign a written informed consent form
排除标准
- •Need for hospitalization according to updated French guidelines (ministère de la santé_04/04/2020)
- •Patient in long-term care facility
- •Patient without concern confirmation of COVID-19 by laboratory (PCR swab) test or chest CT
- •Known hypersensitivity or contra-indication to the 3 experimental treatments (azithromycin, hydroxychloroquine, lopinavir/ritonavir).
- •Any reason making follow up of the patient impossible during the study period.
研究组 & 干预措施
Azithromycin
Azithromycin
干预措施: Azithromycin (Drug)
Hydroxychlororquine
Hydroxychlororquine
干预措施: Hydroxychloroquine (Drug)
Lopinavir/Ritonavir
Lopinavir/Ritonavir
干预措施: Lopinavir 200Mg/Ritonavir 50Mg Tab (Drug)
结局指标
主要结局
Hospital admission
时间窗: Day 20
Hospitalization at D20
次要结局
- Effect of treatment on need for ICU stay at D60(Day 60)
- Effect of treatment on duration of ICU stay at D20(Day 20)
- Effect of treatment on Death at D20(Day 20)
- Effect of treatment on Death at D60(Day 60)
- Effect of treatment on Death due to COVID at D20(Day 20)
- Effect of treatment on duration of mechanical ventilation at D60(Day 60)
- Effect of treatment on Duration of Hospital stay et D20(Day 20)
- Incidence of Treatment-Emergent Adverse Events(Month 6)
- Effect of treatment on Death due to COVID at D60(Day 60)
- Effect of treatment on need for ICU stay at D20(Day 20)
- Effect of treatment on duration of ICU stay at D60(Day 60)
- Effect of treatment on duration of mechanical ventilation at D20(Day 20)
- Effect of treatment on time to hospitalization at D20(Day 20)
- Effect of treatment on Duration of Hospital stay et D60(Day 60)
- Effect of treatment on need of mechanical ventilation at D20(Day 20)
- Effect of treatment on time to hospitalization at D60(Day 60)
- Effect of treatment on Duration of symptoms at D20(Day 20)
- Effect of treatment on need of mechanical ventilation at D60(Day 60)
- Effect of treatment on Duration of symptoms at D60(Day 60)