Interim analysis of an open-label randomized controlled trial evaluating nasal irrigations in non-hospitalized patients with coronavirus disease 2019.
Interim analysis of an open-label randomized controlled trial evaluating nasal irrigations in non-hospitalized patients with coronavirus disease 2019.
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DOI：
10.1002/alr.22703
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发表时间：
2020-12
影响因子：
6.4
通讯作者：
Turner JH
中科院分区：
文献类型：
--
作者：
Kimura KS;Freeman MH;Wessinger BC;Gupta V;Sheng Q;Huang LC;Von Wahlde K;Das SR;Chowdhury NI;Turner JH
方法我们从范德比尔特大学医学中心和附属检测中心获得了SARS冠状病毒2型定性RT-PCR诊断试验阳性的患者。患者在检测后24小时内入组研究，并接受拭子、病毒保存培养基和症状日记，其中包含经验证的威斯康星州上呼吸道症状-21调查（WURSS-21）的修改版本（Supp.图1）7.将患者随机分配至三个治疗组之一：1）每日两次用250 cc高渗盐水（HTS）冲洗，2）每日两次用含1%表面活性剂的高渗盐水（HTSS）冲洗，3）非干预（NI）组（Supp.图2）。在21天的研究期间，参与者按计划进行中鼻甲拭子检查，并记录每日温度和症状评分。之前的一项横断面研究发现，患者进行的中鼻甲拭子和医护人员进行的鼻咽拭子之间的敏感性相同且相关性较高8。研究方法和功率分析的全面细节中提供的方法部分在补充Appendix.ResultsWe完成的症状问卷，其中包括17例患者在无干预组，14个在高渗盐水和盐水+表面活性剂组（Supp.表1）。各组在年龄、性别、合并症和其他人口统计学和/或临床因素方面相似。诊断前症状天数的中位数范围为2.0 - 2.5，组间无差异。研究完成情况也相似，每个治疗组有3例患者失访。
MethodsWe identified patients diagnosed with a positive qualitative RT-PCR SARS-CoV-2 diagnostic test obtained from Vanderbilt University Medical Center and affiliated testing centers. Patients were enrolled in the study within 24 hours of testing and were given swabs, viral preservation media, and a symptom diary incorporating a modified version of the validated Wisconsin Upper Respiratory Symptom-21 Survey (WURSS-21)(Supp. Fig. 1) 7. Patients were randomized to one of three treatment arms: 1) twice daily irrigation with 250cc hypertonic saline (HTS), 2) twice daily irrigation with hypertonic saline with 1% surfactant (HTSS) and 3) a non-intervention (NI) group (Supp. Fig. 2). Participants performed scheduled mid-turbinate swabs and recorded daily temperatures and symptom scores over the 21-day study duration. A prior cross-sectional study found equivalent sensitivity and high correlation between patient-performed mid-turbinate swabs and nasopharyngeal swabs performed by health care workers 8. Comprehensive details of study methodology and power analysis are provided in the Methods section in the Supplementary Appendix.ResultsWe performed an interim analysis on the first 45 patients with completed symptom questionnaires, which included 17 patients in the no intervention group, and 14 each in the hypertonic saline and saline+ surfactant groups (Supp. Table 1). The groups were similar with respect to age, sex, comorbidities, and other demographic and/or clinical factors. The median number of symptomatic days before diagnosis ranged from 2.0 to 2.5 and did not differ between groups. Study completion was also similar with three patients lost to follow-up in each treatment arm.
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