PDF(Pubmed)
Abstract：
The nose is the portal for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection, suggesting the nose as a target for topical antiviral therapies. The purpose of this study was to assess both the in vivo and in vitro efficacy of a detergent-based virucidal agent, Johnson and Johnson\'s Baby Shampoo (J&J), in SARS-CoV-2-infected subjects.
Subjects were randomized into three treatment groups: (1) twice daily nasal irrigation with J&J in hypertonic saline, (2) hypertonic saline alone, and (3) no intervention. Complementary in vitro experiments were performed in cultured human nasal epithelia. The primary outcome measure in the clinical trial was change in SARS-CoV-2 viral load over 21 days. Secondary outcomes included symptom scores and change in daily temperature. Outcome measures for in vitro studies included change in viral titers.
Seventy-two subjects completed the clinical study (n = 24 per group). Despite demonstrated safety and robust efficacy in in vitro virucidal assays, J&J irrigations had no impact on viral titers or symptom scores in treated subjects relative to controls. Similar findings were observed administering J&J to infected cultured human airway epithelia using protocols mimicking the clinical trial regimen. Additional studies of cultured human nasal epithelia demonstrated that lack of efficacy reflected pharmacokinetic failure, with the most virucidal J&J detergent components rapidly absorbed from nasal surfaces.
In this randomized clinical trial of subjects with SARS-CoV-2 infection, a topical detergent-based virucidal agent had no effect on viral load or symptom scores. Complementary in vitro studies confirmed a lack of efficacy, reflective of pharmacokinetic failure and rapid absorption from nasal surfaces.
Subjects were randomized into three treatment groups: (1) twice daily nasal irrigation with J&J in hypertonic saline, (2) hypertonic saline alone, and (3) no intervention. Complementary in vitro experiments were performed in cultured human nasal epithelia. The primary outcome measure in the clinical trial was change in SARS-CoV-2 viral load over 21 days. Secondary outcomes included symptom scores and change in daily temperature. Outcome measures for in vitro studies included change in viral titers.
Seventy-two subjects completed the clinical study (n = 24 per group). Despite demonstrated safety and robust efficacy in in vitro virucidal assays, J&J irrigations had no impact on viral titers or symptom scores in treated subjects relative to controls. Similar findings were observed administering J&J to infected cultured human airway epithelia using protocols mimicking the clinical trial regimen. Additional studies of cultured human nasal epithelia demonstrated that lack of efficacy reflected pharmacokinetic failure, with the most virucidal J&J detergent components rapidly absorbed from nasal surfaces.
In this randomized clinical trial of subjects with SARS-CoV-2 infection, a topical detergent-based virucidal agent had no effect on viral load or symptom scores. Complementary in vitro studies confirmed a lack of efficacy, reflective of pharmacokinetic failure and rapid absorption from nasal surfaces.
摘要：
背景：鼻子是严重急性呼吸道综合征-冠状病毒-2（SARS-CoV-2）感染的门户，建议将鼻子作为局部抗病毒治疗的目标。这项研究的目的是评估基于洗涤剂的杀病毒剂的体内和体外功效，约翰逊和约翰逊的婴儿洗发水（J＆J），在SARS-CoV-2感染的受试者中。
方法：受试者随机分为三个治疗组：（1）每天两次使用J＆J高渗盐水进行鼻腔冲洗，(2)单独使用高渗盐水，（3）不干预。在培养的人鼻上皮中进行了补充的体外实验。临床试验中的主要结果指标是SARS-CoV-2病毒载量在21天内的变化。次要结果包括症状评分和每日温度变化。体外研究的结果测量包括病毒滴度的变化。
结果：72名受试者完成了临床研究（每组n=24）。尽管在体外杀病毒试验中证明了安全性和强大的功效，相对于对照,J&J冲洗对治疗的受试者中的病毒滴度或症状评分没有影响。使用模拟临床试验方案的方案对感染的培养的人气道上皮施用J&J观察到类似的发现。对培养的人鼻上皮的其他研究表明，缺乏疗效反映了药代动力学失败，与大多数杀病毒J&J洗涤剂成分迅速从鼻表面吸收。
结论：在这项针对SARS-CoV-2感染受试者的随机临床试验中，基于洗涤剂的局部杀病毒剂对病毒载量或症状评分无影响.补充的体外研究证实了缺乏疗效，反映药代动力学失败和从鼻表面快速吸收。
方法：受试者随机分为三个治疗组：（1）每天两次使用J＆J高渗盐水进行鼻腔冲洗，(2)单独使用高渗盐水，（3）不干预。在培养的人鼻上皮中进行了补充的体外实验。临床试验中的主要结果指标是SARS-CoV-2病毒载量在21天内的变化。次要结果包括症状评分和每日温度变化。体外研究的结果测量包括病毒滴度的变化。
结果：72名受试者完成了临床研究（每组n=24）。尽管在体外杀病毒试验中证明了安全性和强大的功效，相对于对照,J&J冲洗对治疗的受试者中的病毒滴度或症状评分没有影响。使用模拟临床试验方案的方案对感染的培养的人气道上皮施用J&J观察到类似的发现。对培养的人鼻上皮的其他研究表明，缺乏疗效反映了药代动力学失败，与大多数杀病毒J&J洗涤剂成分迅速从鼻表面吸收。
结论：在这项针对SARS-CoV-2感染受试者的随机临床试验中，基于洗涤剂的局部杀病毒剂对病毒载量或症状评分无影响.补充的体外研究证实了缺乏疗效，反映药代动力学失败和从鼻表面快速吸收。
