Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- qRT-PCR
研究概览
简要总结
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
详细描述
This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Empty capsule will sub-cutaneous injection of ivermectin will be used
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease
- •Age 18 and above
- •BMI 18-28 kg/m
排除标准
- •Allergy to any drug
- •Co-morbidities: any pre-existing cardiac disease, pulmonary disease
- •Arrhythmias
- •Pregnancy
- •RT-PCR performed >3 days prior to enrollment
研究组 & 干预措施
Ivermectin alone
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
干预措施: Ivermectin Injectable Solution (Drug)
Ivermectin alone
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
干预措施: Placebo empty capsule (Drug)
Ivermectin with Zinc
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Ivermectin Injectable Solution (Drug)
Ivermectin with Zinc
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Zinc (Drug)
Ivermectin with Zinc
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Placebo empty capsule (Drug)
Placebo
Placebo drug plus standard care
干预措施: Injectable Placebo (Other)
Placebo
Placebo drug plus standard care
干预措施: Placebo empty capsule (Drug)
Ivermectin (oral) alone
Oral ivermectin 0.2mg/kg/day
干预措施: Placebo empty capsule (Drug)
Ivermectin (oral) alone
Oral ivermectin 0.2mg/kg/day
干预措施: Oral Ivermectin (Drug)
Ivermectin (oral) with Zinc
Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Zinc (Drug)
Ivermectin (oral) with Zinc
Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Placebo empty capsule (Drug)
Ivermectin (oral) with Zinc
Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Oral Ivermectin (Drug)
Zinc Alone
20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Zinc (Drug)
Zinc Alone
20mg Zinc Sulphate 8 hourly plus standard care
干预措施: Placebo empty capsule (Drug)
结局指标
主要结局
qRT-PCR
时间窗: 14 days
time needed to turn positive COVID-19 PCR to negative
Time taken for alleviation of symptoms
时间窗: upto 14 days
time needed to turn off symptoms
Severity of symptoms
时间窗: upto 14 days
time needed of symptom serverity
次要结局
- Severity of symptoms(14 days)
- Morality(30 days)
研究者
Sohaib Ashraf
Post-Graduate Resident Cardiology
Sheikh Zayed Federal Postgraduate Medical Institute