Multi-centre Randomised Controlled Trial of Chloroquine/Hydroxychloroquine Versus Standard of Care for Treatment of Mild Covid-19 in HIV-positive Outpatients in South Africa
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Event-free survival at 28 days post-randomization between experimental group and standard of care group
研究概览
简要总结
Clinical manifestations of Covid-19 are poorly characterised in HIV co-infection, which may predispose to more severe disease. Reducing hospitalisation and severe illness in this population has important individual and public health benefits. The investigators propose a pragmatic multi-centre, randomized controlled trial in South Africa to evaluate the efficacy and safety of chloroquine or hydroxychloroquine to prevent progression of disease and hospitalisation amongst HIV-positive people with Covid-19 not requiring hospitalisation at initial assessment.
详细描述
The trial objective is to compare chloroquine (or hydroxychloroquine) versus standard of care for the primary endpoint of hospitalisation or death at 28 days. Consenting adults who meet criteria for a Covid-19 person under investigation and who are ≥18 years, known to be HIV-positive, not requiring immediate hospitalisation and are not at risk of cardiac toxicities related to the study drug will be enrolled. The total sample size will be 560 participants (280 in each arm).
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
- •Tested for Covid-19 at a trial recruitment site as an outpatient;
- •Age 18 years or older;
- •Not requiring immediate hospitalisation;
- •Mild disease, defined as respiratory rate <25/min, pulse rate <120/min, SpO2 >94%;
- •HIV-positive by rapid test or documented history;
- •Suspected or confirmed Covid-19;
- •Signed informed consent.
排除标准
- •Covid-19 diagnosed > 5 days prior to randomization;
- •Active tuberculosis;
- •Need for concomitant drugs that are contraindicated with the use of Chloroquine/hydroxychloroquine;
- •QTcF interval > 480 ms;
- •Known glomerular filtration rate < 10 ml/min;
- •Known with glucose-6-phosphate dehydrogenase deficiency (G6PD);
- •Previous adverse drug reaction to investigational product;
- •Concurrent involvement in other research or use of chloroquine, hydroxychloroquine or any other 4-aminoquinolone or another experimental investigational medicinal product that is likely to interfere with the study medication.
- •Note: Pregnancy and breastfeeding are not exclusions for entry
研究组 & 干预措施
Arm 1: Chloroquine or hydroxychloroquine
Loading dose of 4 tablets (150 mg chloroquine base per chloroquine salt tablet; 155 mg chloroquine base per hydroxychloroquine tablet) at time 0 and 6 hours, followed by a maintenance dose of 2 tablets at time 12 hours, and then twice daily for a total of 7 days.
干预措施: Chloroquine or hydroxychloroquine (Drug)
结局指标
主要结局
Event-free survival at 28 days post-randomization between experimental group and standard of care group
时间窗: Day 28
Events defined as Hospitalisation or Death
次要结局
- Premature discontinuation of treatment(Day 28)
- Proportion with moderate and severe ARDS(Day 28)
- Time from treatment initiation to death, ARDS (PF/SF ratio < 300), or mechanical ventilation(Day 28)
- Duration of hospitalisation and ICU stay in survivors(Day 28)
- Incidence of serious adverse events(Day 28)
- Incidence of adverse events of special interest related to investigational product at time of hospitalisation(Day 28)
- Incidence of Covid-19 in household contacts(Day 28)
研究者
Sean Wasserman
Principal Investigator
University of Cape Town