SSPC, The Science Foundation Ireland Research Centre for Pharmaceuticals, Ireland; Bernal Institute, University of Limerick, Ireland.
SSPC, The Science Foundation Ireland Research Centre for Pharmaceuticals, Ireland; School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Ireland.
Med Hypotheses. 2020 Oct;143:110110. doi: 10.1016/j.mehy.2020.110110. Epub 2020 Jul 15.
Current formulations and dose regimens of hydroxychloroquine (HCQ) put patients at risk of harm. An analysis of clinical trials registered on ClinicalTrials.gov revealed that this may continue as many studies combine HCQ with agents that prolong the QT interval. Further, almost all of the trials registered do not consider dosage adjustment in the elderly, a patient population most likely to require HCQ treatment. Here we describe an inhaled formulation of HCQ which has passed safety studies in clinical trials for the treatment of asthma and discuss how this approach may reduce side-effects and improve efficacy. As this simple formulation progressed to phase II studies, safety data can be used to immediately enable phase II trials in COVID-19.
目前的羟氯喹(HCQ)制剂和剂量方案使患者面临伤害风险。对 ClinicalTrials.gov 上注册的临床试验进行分析后发现,这种情况可能会持续下去,因为许多研究将 HCQ 与延长 QT 间期的药物联合使用。此外,几乎所有注册的试验都没有考虑在老年人中调整剂量,而老年人是最需要 HCQ 治疗的患者群体。在这里,我们描述了一种 HCQ 的吸入制剂,该制剂已在临床试验中通过了治疗哮喘的安全性研究,并讨论了这种方法如何降低副作用和提高疗效。随着这种简单制剂进入 II 期研究,安全性数据可立即用于 COVID-19 的 II 期试验。