Ivermectin Role in Severe Covid-19 Treatment; a Double-blinded, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Reduction in the WHO ordinal scale of clinical status by at least two points
研究概览
简要总结
Because ivermectin is being used to treat COVID-19 with insufficient evidence, the investigator conducted a randomized clinical trial to investigate the efficacy and safety of ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. The study was conducted in Shebin-Elkom teaching hospital and recruited patients from December 6, 2020, to January 31, 2021.
详细描述
This study is an adaptive, randomized, double-blinded, controlled trial to evaluate the safety and efficacy of therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a single-center trial that will be conducted in Shebin Elkom teaching hospital. The study will be a series of 3-arm comparisons between two different investigational therapeutic agents (Ivermectin and Hydroxychloroquine) and a placebo. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about the successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.
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
- Double (Participant, Care Provider)
盲法说明
Unlabelled tablets were prepared for each patient in a special envelope in a time-based manner in the central pharmacy
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
- •Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- •Understands and agrees to comply with planned study procedures.
- •Agrees to the collection of OP swabs and venous blood per protocol.
- •Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
- •Severe cases according to WHO definition.
排除标准
- •ALT/AST > 5 times the upper limit of normal.
- •Mortality within 12 hours of admission.
- •Anticipated transfer to another hospital within 24 hours.
- •Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
- •Mechanically ventilated on admission
研究组 & 干预措施
ivermectin
ivermectin was given as a total daily dose of 36 mg on days 0, 3, 6. The daily dose was divided into 3 equal doses of 12 mg (2 tablets) every 8 hours
干预措施: ivermectin (Drug)
hydroxychloroquine
hydroxychloroquine was given as 200 mg (one tablet) every 12 hours for 5 days
干预措施: hydroxychloroquine (Drug)
Placebo
Unlabelled standard treatment according to the clinical condition of patients
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the WHO ordinal scale of clinical status by at least two points
时间窗: 14 days
The ordinal scale consists of 7 points, the maximum score is 7 which indicates a worst outcome, while the minimum score is 1 which indicates a better outcome
Time to discharge
时间窗: within 14 days
time to discharge to home after no more need for hospitalization
次要结局
- Mortality(14 days)
研究者
Hozaifa Elsawah
Clinical Pharmacist
Elaraby Hospital