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临床试验/EUCTR2021-001177-22-DK
EUCTR2021-001177-22-DK进行中(未招募)1 期

Amantadine for COVID-19: A randomized, placebo controlled, double-blinded, clinical trial

Copenhagen University Hospital, Hvidovre , Capital Region0 个研究点目标入组 242 人开始时间: 2021年3月29日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
242

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • ?Population at risk of developing severe COVID-19, defined as either:
  • Age = 40 years of age
  • Age = 18 years of age and at least one known comorbidity
  • Age = 18 years of age and a BMI = 30
  • ?COVID-19 disease confirmed by the presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR) within 5 days prior to inclusion.
  • ?For women of childbearing age (defined as non-sterile premenopausal women): Negative pregnancy test and willingness to use contraceptive during the study period (90 days)
  • ?Provision of informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 121
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 121

排除标准

  • ?Current hospitalization
  • ?Allergy to amantadine hydrochloride, rimantadine or inactive ingredients.
  • ?Known history of:
  • Untreated narrow-angle glaucoma
  • Kidney disease with eGFR < 35 ml/min
  • Heart failure, proarrhythmic conditions, ventricular arrhythmias.
  • Parkinson’s disease
  • Gastric ulcer
  • Liver Disease
  • Hereditary galactose intolerance, lactose intolerance or glucose/galactose malabsorption
  • ?Current use of:
  • Neuroleptics/antipsychotics/ levodopa
  • Anticholinergics
  • ?Concurrent malignancy requiring chemotherapy
  • ?Pregnancy and breastfeeding

研究者

发起方
Copenhagen University Hospital, Hvidovre , Capital Region

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