跳至主要内容
临床试验/ACTRN12620000457943
ACTRN12620000457943撤回2 期

A Randomised, Double Blind, Placebo-Controlled Trial of the Efficacy of Hydroxychloroquine for the Community-Based Treatment of Adults With Diagnosed COVID-19

Medical Research Institute of New Zealand0 个研究点目标入组 70 人开始时间: 2020年4月8日最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
入组人数
70

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • Aged 18 to 75 years.
  • Laboratory confirmed SARS-CoV2 infection.
  • Advised to self-manage COVID-19 in the community by the regional public health team.
  • In the Investigator’s opinion, is able and willing to comply with all trial requirements.
  • Baseline Flu PRO score >1.3
  • Able to receive and commence randomised treatment via courier the day after consent was obtained.

排除标准

  • Known pregnancy or planning to become pregnant during the study period
  • Currently breastfeeding
  • Known maculopathy or retinal disorder.
  • Known cardiac disease/dysrhythmia or prolonged QTc
  • Know renal disease
  • Known hepatic disease
  • Known hypomagnesaemia or hypokalaemia.
  • Currently using hydroxychloroquine or any 4-aminoquinoline.
  • Use of medications prolonging QTc including: Class IA (quinidine, procainamide, disopyramide) and III (amiodarone, sotalol, ibutilide, dofetilide) antiarrythmics, macrolides, methadone, fluoroquinolones, domperidone, fluconazole, ondansetron, tacrolimus, tramadol, anti-retrovirals.
  • Current use of tamoxifen, digoxin, tricyclics, SSRIs, antipsychotics, halfantrine, cyclosporin and anti-epileptic medications
  • Current use of oral hypoglycaemics including glipizide, glyburide, gliclazide, glimepiride, repaglinide, nateglinide, metformin, rosiglitazone, pioglitazone, acarbose, miglitol, voglibose, sitagliptin, saxagliptin, vildagliptin, linagliptin, alogliptin, dapagliflozin, canagliflozin, bromocriptine.
  • Sensitivity or allergy to 4-aminoquinilone compounds or any excipients used in the study
  • Unable to access digital consent forms or maintain remote contact with the study team
  • Have any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

研究者

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