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
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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