Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Epicentre
- 主要终点
- Hospitalization or death
研究概览
简要总结
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.
详细描述
After being informed about the study and potential risks, all patients who meet all eligibility criteria and who give written informed consent will be randomized to receive standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14 days). Participants will receive daily visits from study staff for 15 days and be followed for a total of 28 days.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspect, probable or confirmed case of COVID-19
- •Men and women aged ≥12 years, including pregnant and breastfeeding women
- •SpO2 ≥93% on room air
- •Signature of informed consent form
排除标准
- •Medical indication for hospitalization at the time of enrolment
- •Severe chronic liver disease
- •Known infection with HIV
- •Known allergy or severe intolerance to lopinavir/ritonavir
- •Absolute contra-indication to lopinavir/ritonavir, including concomitant therapy with a medication whose metabolism is dependent on isoform CPY3A with a narrow therapeutic window (e.g., amiodarone, colchicine, simvastatin, lovastatin, etc.)
- •Treatment with an antiviral medication in the 28 days prior to enrolment
- •Dementia or other condition that interferes with active participation in data collection and obtaining informed consent
研究组 & 干预措施
Standard Care
Standard care for COVID-19 according to the national guidelines of Niger
干预措施: Standard Care (Combination Product)
Standard Care plus lopinavir/ritonavir
Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir
干预措施: Lopinavir-Ritonavir Drug Combination (Drug)
Standard Care plus lopinavir/ritonavir
Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir
干预措施: Standard Care (Combination Product)
结局指标
主要结局
Hospitalization or death
时间窗: 15 days following randomization
Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause
次要结局
- Time to hospitalization(28 days following randomization)
- Adverse events(28 days following randomization)
- Serious adverse events(28 days following randomization)
- Length of hospitalization(28 days following randomization)
- Admission to intensive care(28 days following randomization)
- All-cause mortality(28 days following randomization)