Critical Path Institute, 1730 East River Road, Tucson, Arizona, 85718-5893, USA.
Br J Clin Pharmacol. 2021 Sep;87(9):3462-3480. doi: 10.1111/bcp.14630. Epub 2020 Nov 28.
Repurposing strategies to address the COVID-19 pandemic have been accelerated. As both pregnant and paediatric patients are likely to be excluded from most planned investigations, the list of repurposed options and the available data on these drugs and vaccines provide a baseline risk assessment and identify gaps for targeted investigation.
Clinical trials have been searched and reviewed; 23 repurposed drugs and drug combinations and nine candidate vaccines have been assessed regarding the availability of relevant data in paediatrics and pregnant women and to evaluate expected or unanticipated risk.
Thirteen of the repurposed drugs or drug combinations are indicated for use in paediatrics in some age category albeit for indications other than COVID-19; 10 of these are indicated for use in pregnant women. Even in cases where these drugs are indicated in the populations, source data from which safety and or dosing could be extrapolated for use in COVID-19 is sparse. Vaccine trials are ongoing and generally exclude pregnant women; only in a few instances have paediatric subgroups been planned for enrolment. Data from individual case studies and RWD may suggest that subpopulations of both paediatric patients and pregnant women may be more at risk, particularly those in an increased inflammatory state.
In conjunction with more prospective collaboration, plans are evolving to ensure that we will be better prepared to address similar situations especially in paediatrics and pregnant women where experience is limited and actual practice relies heavily on leveraging data from other populations and indications.
为应对 COVID-19 大流行，已加速了重新利用策略。由于大多数计划中的研究都可能排除孕妇和儿科患者，因此重新利用的选择清单以及这些药物和疫苗的可用数据提供了基线风险评估，并确定了针对特定人群进行调查的空白。
已搜索和审查了临床试验；已评估了 23 种重新利用的药物和药物组合以及 9 种候选疫苗，以评估其在儿科和孕妇中是否具有相关数据，并评估预期或意外风险。
在某些年龄组中，有 13 种重新利用的药物或药物组合可用于儿科，尽管并非用于治疗 COVID-19；其中有 10 种药物可用于孕妇。即使在这些药物可用于这些人群的情况下，也很少有可以从原始数据推断出用于 COVID-19 的安全性和/或剂量的数据。疫苗试验正在进行中，通常排除孕妇；只有在少数情况下计划招募儿科亚组。来自个别病例研究和 RWD 的数据可能表明，儿科患者和孕妇的亚组可能面临更大的风险，尤其是那些炎症状态增加的患者。
除了更具前瞻性的合作外，还在制定计划，以确保我们将更好地为类似情况做好准备，尤其是在儿科和孕妇中，因为经验有限，实际做法严重依赖于利用来自其他人群和适应症的数据。
