NCT04854759Unknown3 期
The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms in Patients Infected With the SARS-CoV-2 Virus
Independent Public Clinical Hospital No. 4 in Lublin8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Development of clinical deterioration
研究概览
简要总结
The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus. Multicenter randomized, double-blind, placebo-controlled, non-commercial clinical 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
- Double (Participant, Investigator)
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
- •Men and women aged 18 and over
- •Can give informed consent
- •Confirmed positive result for SARS-CoV-2 within 72 hours from the date the result was issued (according to the laboratory report)
- •Patient presently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnoea, chest pain, diarrhea, nausea, vomiting, anosmia, lack of taste, sore throat, nasal congestion
- •At initial screening, the subject will report at least one and no more than 3 of the following risk factors for clinical worsening: age ≥40, obesity, hypertension, diabetes, pulmonary disease (e.g., asthma, COPD), and immune disorders (e.g. rheumatoid arthritis, lupus), neurological diseases: e.g. after a distant stroke or trauma to the brain, multiple sclerosis, dementia and other neurodegenerative diseases)
- •Patients hospitalized due to meeting the above criteria and requiring observation in a hospital or outpatient setting.
排除标准
- •Disease severe enough to meet the study's primary endpoint of clinical worsening (eg, current O2 saturation <92% with patient exposure to room air, current use of supplemental oxygen to maintain O2 saturation ≥ 92%).
- •WHO score ≥4 (requires oxygen therapy during hospitalization)
- •Concomitant diseases which, in the opinion of the attending physician, prevent the patient from participating in the study, such as: decompensated cirrhosis, active ulcer disease, epilepsy and symptomatic convulsions, untreated angle-closure glaucoma determined on the basis of the patient's interview and / or medical documentation . In addition, immunocompromised patients (solid organ transplant, BMT, AIDS, renal failure (patients with renal impairment may develop drug poisoning) or other diseases not mentioned and other diseases treated with biological, immunological and / or steroids in high doses will not be eligible for the study. doses (> 20 mg prednisone daily).
- •Hypersensitivity to any component of the preparation, severe congestive heart failure, cardiomyopathy, myocarditis, II-III degree AV block, bradycardia, clinically significant prolongation of the QT interval, or a family history of congenital long QT syndrome, severe ventricular arrhythmias (including torsade de pointes), concomitant use of drugs that prolong the QT interval, hypokalaemia, hypomagnesaemia,
- •Pregnancy, the period of breastfeeding.
- •Parallel intake of memantine or other drugs acting on the CNS (neuroleptics, anxiolytics, antiepileptic drugs, antidepressants).
- •Other neurological conditions with agitation or confusion, delirium syndromes or psychoses.
- •Receipt of a partial or full vaccination schedule against SARS-CoV-2 is also an exclusion criterion from the study.
研究组 & 干预措施
Study group
Experimental
干预措施: Amantadine Hydrochloride (Drug)
Control group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Development of clinical deterioration
时间窗: Up to day 15 from randomization
Defined as dyspnoea - physical examination - doctor's assessment
Clinical deterioration occurs
时间窗: Up to day 15 from randomization
Defined as achievement of ≥4 points on the WHO \[OSCI-WHO\] scale (7-point clinical status assessment scale)
次要结局
- General Health Scale (PROMIS® Global Health Scale)(Day 15, 30 complementary visit-optional, 90, 150, 210)
- The neurological assessment(Day 15, 30 complementary visit-optional, 90, 150, 210)
- Time to clinical deterioration(Day 15, 30 complementary visit-optional, 90, 150, 210)
- Survival time(Day 15, 30 complementary visit-optional, 90, 150, 210)
研究者
研究点 (8)
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