Comparative Efficacy of Ivermectin Versus Combination of Hydroxychloroquine Plus Darunavir/ Ritonavir for Shortening Duration of SARS-CoV2 Detection From Respiratory Secretion Among Asymptomatic or Afebrile COVID-19 Infection
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Adverse event rates
研究概览
简要总结
This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.
详细描述
- Study procedure will be carried out after informed consent is obtained.
- Baseline physical exam and laboratory investigations will be performed.
- Eligible patients will be randomized to one of the two treatment arms.
- Symptoms and signs will be monitored daily.
- NP swab will be done at day5-7, and prior to discharge.
- Complete blood counts, blood chemistries, electrocardiography will be performed for adverse event monitoring within 5 days after end of study drugs' administration.
- Patients will be discharged at 2- 4 weeks after hospitalization, according to PCR results.
- There will be 1-2 follow up visit at out patient clinic for NP swab (patients with +ve last NP swab before discharge), and blood tests.
- Additional 5-8 ml. of EDTA blood will be taken at baseline and weekly for antibody detection.
- Interim analysis of both safety and efficacy will be performed when approximately 50% of enrollment is achieved.
- Intention to treat analysis is planned at the completion of enrollment.
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
- Single (Outcomes Assessor)
盲法说明
PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm
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
- •SAR-CoV2 detected by PCR from NP swab
- •Asymptomatic or upper respiratory symptoms such as runny noses
- •No history of fever or oral Temp <37.8 degree celsius
- •informed consent obtained
排除标准
- •Fever or respiratory rate >24/minute or oxygen saturation at room air< 94%
- •Any serious co-morbidity such as chronic lung disease, chronic kidney disease, cardiovascular diseases, arrythmia, diabetes mellitus with HbA1C > 8%, chronic liver disease, lymphocyte count <1,000cell/cu.mm.
- •History of ivermectin or any of the study drug allergy.
- •Concomitant medication with potential drug interaction with any of the study drugs such as alfuzosin, colchicine, ergot derivatives, cisapride, simvastatin and rifampicin
- •Pregnant or lactating woman
研究组 & 干预措施
ivermectin
Combination of
- oral ivermectin 600 mcg/kg/day once daily for 3 days
- Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days
干预措施: Ivermectin Pill (Drug)
ART/hydroxychloroquine
Combination of
- Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5
- Darunavir/ritonavir (400/100mg) every 12 hours for 5 days
- Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days
干预措施: Combined ART/hydroxychloroquine (Drug)
结局指标
主要结局
Adverse event rates
时间窗: after first dose until day 28 of follow up
Comparison of adverse event rates between treatment arms
Efficacy for shortening duration of SAR-CoV2 detection by PCR
时间窗: weekly after treatment until 4th week
comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm
次要结局
- Antibody detection rates(weekly after treatment until 4th week)
研究者
Yupin Suputtamongkol
Professor
Mahidol University