Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 8
- 主要终点
- 50% reduction in symptom score for patients with lower respiratory tract infection
研究概览
简要总结
This is an open label clinical study to evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection. The study aims to document possible prevention of pneumonia in patients staying at home and in improving the symptoms of SARS-CoV-2 pneumonia in patients who will be hospitalised.
详细描述
Humanity has been experiencing a new pandemic of the SARS Coronavirus-19 virus (SARS-CoV-2) since December 2019, causing the disease known as COVID-19. As of March 23, 2020, there have been 382,341 documented episodes of infection worldwide, of which 16,567 have died. An important limitation in the treatment of the disease is the absence of drugs with known antiviral activity against SARS-CoV-2. Recent data suggest that chloroquine has sufficient in vitro activity against the SARS-CoV-2 virus by inhibiting virus entry into cells. It has recently been described that hydroxychloroquine significantly reduces the percentage of patients who have positive sputum in the SARS-CoV-2 virus within 6 days. However, the clinical efficacy of the drug has not been described and it has significant side effects, including more than 10% anorexia, headache, blurred vision, diarrhea or vomiting, and myocardiotoxicity. The frequency of adverse effects of chloroquine in combination with the well-known in vitro activity of chloroquine have led to the design of clinical trials around the world to document the benefits of its use. The present study will evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Both genders
- •For women of childbearing age, they should use or be willing to use a double contraceptive method during the study. A urine pregnancy test to exclude pregnancy will be performed prior to study initiation.
- •Written consent after information provided by the patient or the legal representative in the event that the patient cannot consent.
- •Upper respiratory or lower respiratory tract infection, as in Annexes II and III respectively.
- •Positive respiratory secretion test for SARS-CoV-2 virus by molecular techniques or positive blood IgM titers.
排除标准
- •Under 18 years of age
- •Denial of written consent
- •Any patient case where it has been decided not to rejuvenate
- •Serum AST values greater than 5 times the upper normal range
- •QTc interval in rest electrocardiogram greater than 500msecs
- •Pregnancy or lactation. Urgent pregnancy test to exclude pregnancy before inclusion in the study
研究组 & 干预措施
UNIKINON (Chloroquine phosphate)
Once a patient is considered eligible for the study, they will receive oral chloroquine phosphate. The total duration of treatment will be 7 days. The dosage will be 500mg every 12 hours. It is clarified that any other treatment at the discretion of the therapist is permitted except for the administration of hydroxychloroquine.
干预措施: UNIKINON (Chloroquine phosphate) 200mg tablets (Drug)
结局指标
主要结局
50% reduction in symptom score for patients with lower respiratory tract infection
时间窗: Day 8 visit from study initiation
Achieving 50% reduction in symptom score for patients with lower respiratory tract infection on day 8 visit from study initiation.
Lack of progression for patients with upper respiratory tract infection
时间窗: Day 8 visit from study initiation
Lack of progression to lower respiratory tract infection in patients enrolled in the study due to upper respiratory tract infection on day 8 visit from study initiation.
次要结局
- Frequency of AEs and SAEs(Day 14 visit from study initiation)
- Comparison of the primary endpoint with respective patients not receiving the treatment(Day 14 visit from study initiation)
- Serious respiratory failure until day 14. This will be compared with respective patients not receiving the treatment.(Day 14 visit from study initiation)