A Randomized Clinical Trial to Investigate Safety & Efficacy of Low-dose Aspirin / Ivermectin Combination Therapy in Management of COVID-19 Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 490
- 主要终点
- SARS COV 2 Viral clearance
研究概览
简要总结
COVID-19, caused by the novel Severe Acute Respiratory Syndrome Corona Virus 2 (SARSCoV-2), has become a global pandemic. Fortunately, most of the COVID-19 cases confirmed are categorized as mild for whom home- based symptomatic management with monitoring of clinical deterioration is recommended. Despite providing symptomatic management, a therapeutic drug that would limit the course of infection is greatly needed to stop COVID-19 disease progression. Considering the current SARS-CoV-2 epidemiology and the legitimate rash towards appropriate therapies, our study seeks to evaluate the safety and efficacy of low dose aspirin and ivermectin combination therapy in COVID-19 patients.
详细描述
Micro clotting is to date reported as a major cause of death among COVID-19 patients. SARS-CoV-2 associated micro clotting results into acute respiratory distress syndrome (ARDS) and death. This micro-clotting cascade supports the potential role of anticoagulants like aspirin, heparin in the clinical management of COVID-19 patients. Other areas that could be considered for potential treatment of COVID-19 include drugs and analogues of drugs that have demonstrated potential in-vitro and or in-vivo activity against SARS-CoV-2 like hydroxychloroquine, azithromycin, lopinavir/ritonavir and remdesivir and ivermectin. Ivermectin has demonstrated broad-spectrum anti-viral activity and inhibition of the causative virus (SARS-CoV-2) with ability to cause a 5000-fold reduction in viral RNA within 48hrs.
Although aspirin and ivermectin do not exhibit any synergistic or potentiation at cellular level, a clinical additive effect resulting from combination therapy with low dose aspirin and ivermectin is plausible. There is no documented drug-drug interactions or other biological basis that contra-indicate co-administration of low dose aspirin and ivermectin.
We therefore propose, to explore the clinical use of combination anticoagulant: lower dose aspirin and the FDA-approved anti-parasitic drug: ivermectin, in treatment of COVID-19 patients in an exploratory randomized trial.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Willingness to comply with all study procedures and availability over the study duration *Patients aged above 18years to 64 years
- •PCR positive for SARS-Cov-2 (COVID-19) from any of the MOH COVID-19 accredited testing laboratories
- •Moderately ill COVID-19 patients score 3(Hospitalized with no oxygen therapy) to 4 (Hospitalized with oxygen by mask or nasal prongs) according to the WHO ordinal scale for clinical improvement which translates to moderate to severe COVID-19 patients according to the Ministry of Health Uganda COVID-19 disease category.
- •Exclusion criteria:
- •Participants with known hypersensitivity to Ivermectin
- •Clinical diagnosis of severe renal and hepatic impairment.
- •Pregnancy or breast feeding.
- •Co-treatment with either strong cytochrome p-450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affected ivermectin disposition and clinical outcomes
- •Co-morbidities including asthma
- •Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan in the last 4 years
- •Persons clinically diagnosed with and receiving treatment for any diathesis and PUD
- •Active participation in another clinical trial
排除标准
- 未提供
研究组 & 干预措施
Arm 2
Drug: 3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1)
干预措施: 3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1) (Drug)
Arm 3
3-day Ivermectin 600 mcg/kg/day/14-day 75mgASA/day + standard of care (Intervention 2)
干预措施: 3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1) (Drug)
结局指标
主要结局
SARS COV 2 Viral clearance
时间窗: Day 14
SARS COV 2 Viral load
World Health Organization COVID-19 ordinal improvement score
时间窗: Day 14
Minimum score is 0 (un infected, no clinical or virological evidence of infection) Maximum sore is 8 (death) Higher scores mean a worse outcome, low scores mean a better outcome
次要结局
- Spectrum and severity of adverse events(Days one to day 14)
- Clinical recovery(Day 14)
- Maximum Plasma concentration(Days one to six)
- Minimum Plasma concentration(Days one to six)
- Area Under the Curve(Days one to six)
研究者
College of Health Sciences
Chair and Associate professor Department of Pharmacology and Therapeutics
Makerere University