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Coalition: Advocacy for prospective clinical trials to test the post-exposure potential of hydroxychloroquine against COVID-19

机译:联盟:倡导进行前瞻性临床试验以测试羟氯喹对COVID-19的暴露后潜力

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摘要

Our coalition of public health experts, doctors, and scientists worldwide want to draw attention to the need for high-quality evaluation protocols of the potential beneficial effect of hydroxychloroquine (HCQ) as a post-exposure drug for exposed people. In the absence of an approved, recognized effective pre or post-exposure prophylactic drug or vaccine for COVID-19, nor of any approved and validated therapeutic drug, coupled with social and political pressure raised by publicity both regarding the potential beneficial effect of hydroxychloroquine (HCQ) as well as potential risks from HCQ, we urge the immediate proper clinical trials. Specifically, we mean using HCQ for post-exposure of people with close contact with patients with positive COVID19 rtPCR, including home and medical caregivers. We have reviewed the mechanisms of antiviral effect of HCQ, the risk-benefit ratio taking into consideration the PK/PD of HCQ and the thresholds of efficacy. We have studied its use as an antimalarial, an antiviral, and an immunomodulating drug and concluded that the use of HCQ at doses matching that of the standard treatment of Systemic Lupus erythematous, which has proven safety and efficacy in terms of HCQ blood and tissue concentration adapted to bodyweight (2,3), at 6 mg/kg/day 1 (loading dose) followed by 5 mg/kg/ day, with a maximum limit of 600 mg/day in all cases should swiftly be clinically evaluated as a post-exposure drug for exposed people.
机译:我们由全球公共卫生专家,医生和科学家组成的联盟希望引起人们的关注,即需要高质量评估方案,以评估羟氯喹(HCQ)作为暴露后人群的暴露后药物的潜在有益作用。没有针对COVID-19的经批准,公认的有效暴露前或暴露后预防性预防药物或疫苗,也没有任何经批准和验证的治疗性药物,以及宣传引起的社会和政治压力,均涉及羟氯喹的潜在有益作用( HCQ)以及HCQ带来的潜在风险,我们敦促立即进行适当的临床试验。具体而言,我们的意思是使用HCQ对与COVID19 rtPCR阳性的患者(包括家庭和医疗护理人员)密切接触的人进行接触后治疗。我们已经考虑了HCQ的抗病毒作用机制,风险收益比,并考虑了HCQ的PK / PD和功效阈值。我们已经研究了其作为抗疟药,抗病毒药和免疫调节药的用途,并得出结论,以与标准治疗系统性红斑狼疮的剂量相匹配的剂量使用HCQ,在HCQ血液和组织浓度方面已证明其安全性和有效性适应体重(2,3),以6 mg / kg /天1(负荷剂量),然后以5 mg / kg /天,在所有情况下最高限制为600 mg / day进行临床后评估-暴露人群的暴露药物。

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