From the Division of Infectious Diseases and Departments of Biostatistics and Bioinformatics and Medicine, Duke University School of Medicine, Durham, North Carolina, and UnityPoint Health, Des Moines, Iowa.
South Med J. 2022 Apr;115(4):256-261. doi: 10.14423/SMJ.0000000000001374.
The coronavirus disease 2019 (COVID-19) pandemic has disproportionately afflicted vulnerable populations. Older adults, particularly residents of nursing facilities, represent a small percentage of the population but account for 40% of mortality from COVID-19 in the United States. Racial and ethnic minority individuals, particularly Black, Hispanic, and Indigenous Americans have experienced higher rates of infection and death than the White population. Although there has been an unprecedented explosion of clinical trials to examine potential therapies, participation by members of these vulnerable communities is crucial to obtaining data generalizable to those communities.
We undertook an open-label, factorial randomized clinical trial examining hydroxychloroquine and/or azithromycin for hospitalized patients.
Of 53 screened patients, 11 (21%) were enrolled. Ten percent (3/31) of Black patients were enrolled, 33% (7/21) of White patients, and 50% (6/12) of Hispanic patients. Forty-seven percent (25/53) of patients declined participation despite eligibility; 58%(18/31) of Black patients declined participation. Forty percent (21/53) of screened patients were from a nursing facility and 10% (2/21) were enrolled. Enrolled patients had fewer comorbidities than nonenrolled patients: median modified Charlson comorbidity score 2.0 (interquartile range 0-2.5), versus 4.0 (interquartile range 2-6) for nonenrolled patients ( 0.006). The limitations of the study were the low participation rate and the multiple treatment trials concurrently recruiting at our institution.
The high rate of nonparticipation in our trial of nursing facility residents and Black people emphasizes the concern that clinical trials for therapeutics may not target key populations with high mortality rates.
2019 年冠状病毒病（COVID-19）大流行对弱势群体造成了不成比例的影响。老年人，尤其是疗养院的居民，在人口中所占比例很小，但占美国 COVID-19 死亡人数的 40%。少数族裔和族裔群体，尤其是黑人和西班牙裔以及美国原住民，其感染和死亡人数高于白人。尽管为研究潜在疗法进行了前所未有的临床试验爆炸，但这些弱势群体成员的参与对于获得可推广到这些社区的数据至关重要。
我们进行了一项开放标签，析因随机临床试验，以检查羟氯喹和/或阿奇霉素对住院患者的疗效。
在筛选出的 53 名患者中，有 11 名（21%）入选。黑人患者中有 10%（3/31），白人患者中有 33%（7/21），西班牙裔患者中有 50%（6/12）。尽管符合条件，但仍有 58%（18/31）的黑人患者和 47%（25/53）的患者拒绝参加。筛查出的 53 名患者中有 47%（25/53）来自疗养院，其中 10%（2/21）入选。入选患者的合并症少于未入选患者：中位改良 Charlson 合并症评分 2.0（四分位距 0-2.5），而非入选患者为 4.0（四分位距 2-6）（P=0.006）。研究的局限性在于参与率低和我们机构同时进行的多项治疗试验。
我们的疗养院居民和黑人参与临床试验的比例很高，这强调了一个令人担忧的问题，即针对高死亡率的关键人群的治疗方法临床试验可能无法针对这些人群。
