NCT04952519终止3 期
Efficacy of Amantadine Treatment in COVID-19 Patients
Noblewell12 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2021年3月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 193
- 试验地点
- 12
- 主要终点
- Time to recovery
研究概览
简要总结
Demonstration of the efficacy of amantadine over placebo in the population of patients with moderate or severe COVID-19 in the initial stage of the disease treated in the hospital
详细描述
Use of high-doses of amantadine in hospitalized patients in the early phase of moderate or severe COVID-19, compared to placebo, will shorten the duration of the disease and reduce the risk of death and treatment with invasive mechanical ventilation in Intensive Care Units (ICU).
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
- Triple (Participant, Care Provider, 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
- •Age of respondents - 18 years and older.
- •Confirmation of SARS-CoV-2 infection by PCR
- •Hospitalized patient with COVID-19, defined according to the following criteria (all of the following criteria must be present):
- •radiological (X-ray of klp or TK klp) features of pneumonia,
- •blood saturation (SaO2) measured at rest in the absence of oxygen <95%,
- •it is not necessary to apply on the day of patient enrollment: high-flow oxygen therapy or mechanical ventilation (non-invasive or invasive).
- •Time up to 10 days from the onset of COVID-19 symptoms. The onset of COVID-19 symptoms is the first day on which the first symptom typical for SARS-CoV-2 or COVID-19 infection (in the opinion of the attending physician at the center) occurred, such as: fever, cough, shortness of breath, changes in taste or smell , muscle pain, chest pain, diarrhea, nausea, vomiting, sore throat, nasal congestion.
排除标准
- •Pregnancy or lactation
- •Presence of medical contraindications for inclusion in the examination in the opinion of the attending physician, in particular:
- •a) comorbidities: i) clinically significant hepatic or renal insufficiency; ii) epilepsy or seizures (current or history of); iii) psychiatric or somatic diseases (present or in a history of agitation or confusion, delirium syndromes or exogenous psychoses); iv) cardiovascular diseases such as: severe congestive heart failure, cardiomyopathy, myocarditis, grade II-IV AV block, bradycardia, QT prolongation, perceived U waves or family history of congenital long QT syndrome, severe ventricular arrhythmias a history of heart (including torsade de pointes); v) diseases or conditions that significantly reduce the immunity of a patient (e.g. solid organ transplant, bone marrow transplantation (BMT), AIDS, immune biologics and / or high-dose steroids (> 20 mg prednisone daily).
- •b) hypersensitivity to any component of the preparation, c) parallel use of drugs that prolong the QT interval, d) hypokalemia or hypomagnesaemia, e) untreated angle-closure glaucoma, f) use of amantadine currently or in the last 3 months prior to study inclusion; g) participation in another clinical program
研究组 & 干预措施
Amantadine
Experimental
干预措施: Amantadine (Drug)
Placebo
Placebo Comparator
干预措施: Amantadine (Drug)
结局指标
主要结局
Time to recovery
时间窗: 28 days
Time to recovery, defined as the first day during the 28-day clinical follow-up during which the patient's clinical condition is graded 1, 2, or 3 on an eight-point "Normal Symptom Score"
次要结局
未报告次要终点
研究者
研究点 (12)
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