Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community With Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide in Decreasing Recovery Time
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Hospital admission or mortality related to COVID-19
研究概览
简要总结
There is an urgent need to identify effective treatments for SARS-CoV-2 infection that helps people recover quicker and reduces the need for hospital admission. The investigators develop an open, adaptive, platform trial to evaluate treatments, Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide suitable for use in the community for treating COVID-like-illness that might help people recover sooner and prevent hospitalisation.
详细描述
There is an urgent need to identify interventions against COVID-19 suitable for wide use in the community that have been proven to be effective in reducing symptom duration or hospitalisation. There is urgent need to know whether potential COVID-19 treatments such as Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide that are available for rapid pragmatic evaluation might modify the course of COVID-19 infections, particularly among those who are at higher risk of complications, such as those aged 50 years and over with comorbidity and those aged 65 years and over.
Most reported trials have been conducted in hospital settings, and there is little evidence from community settings, where most people with COVID-19 receive care and where deployment of effective early treatment could speed time to recovery and reduce complications. The investigators established a multi-arm, adaptive platform, randomised controlled trial for community treatment of COVID-19 syndromic illness in people at higher risk of an adverse illness course.
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
- •COVID-1 9 patients with mild symptoms and the results were confirmed by Antigen Test Kit or PCR for SARS-CoV-
- •People who have symptoms consistent with COVID-19 and test positive for SARS-CoV-2 infection within 48 hours of being known.
- •Participants are 18 years of age or older.
排除标准
- •Almost recovered (generally much improved and symptoms now mild or almost absent)
- •Judgement of the recruiting clinician deems ineligible.
- •Previous randomisation to an arm of the trial
- •Pregnancy
- •Breastfeeding
- •Known severe hepatic impairment.
- •Known severe renal impairment.
- •Currently taking Fluvoxamine, Bromhexine, Cyproheptadine, or Niclosamide
研究组 & 干预措施
Fluvoxamine Arm
The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime.
干预措施: FluvoxaMINE Maleate 50 MG (Drug)
Fluvoxamine in Combination with Bromhexine Arm
The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime. Co- administration with bromhexine 8 mg, 1 tablet twice taken after meals and taken at least 8 hours apart, for 10 days.
干预措施: Fluvoxamine, Bromhexine (Combination Product)
Fluvoxamine in Combination with Cyproheptadine Arm
The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime. Co- administration with cyproheptadine 4 mg, 1 tablet, three times, orally after meals and should be taken every 8 hours apart, for 14 days.
干预措施: Fluvoxamine, Cyproheptadine (Combination Product)
Niclosamide Arm
The subjects received 1 tablet of niclosamide 1000 mg orally in divided doses twice a day. After meals in the morning and evening for a total of 14 days.
干预措施: Niclosamide Pill (Drug)
Niclosamide in Combination with Bromhexine Arm
The subjects received 1 tablet of niclosamide 1000 mg orally in divided doses twice a day. After meals in the morning and evening for a total of 14 days. Co-administration with bromhexine 8 mg, 1 tablet twice taken after meals and taken at least 8 hours apart, for 10 days.
干预措施: Niclosamide, Bromhexine (Combination Product)
结局指标
主要结局
Hospital admission or mortality related to COVID-19
时间窗: Within 28 days
Contacts with health services reported by patients and/or captured by reports of patients' medical records
Time taken to self- report recovery
时间窗: Enrolment through final day of participation
Patient reports the day they feel recovered
Progression to severe COVID-19 Disease
时间窗: Enrolment through final day of participation
O2 saturation \<92% on room air (in two consecutive measurements at least 2 hours apart) OR 2) requirement of hospitalization OR 3) need for artificial ventilation OR 4) death.
次要结局
- Reduction (change) in GI viral shedding (by PCR)(Days 0,7,14)
- Change in respiratory viral clearance (by PCR)(Days 0,7,14)
- Time to resolution of a fever(Enrolment through final day of participation)
- Negative effects on well being(Days 0,7,15,28,60)
研究者
Dhammika Leshan Wannigama, MD
Fellow and Scientist
Chulalongkorn University