目的:目的是评估海水洗鼻对症状持续时间的疗效,鼻内病毒载量,COVID-19和URTIS的家庭传播。
方法:这种前瞻性,随机化,控制,多中心,平行研究纳入355例轻度/中度COVID-19和URTI成人,鼻部症状≤48h.活性组用未稀释的等渗海水每天进行4次鼻腔冲洗,而对照组(不进行鼻腔冲洗)。使用WURSS-21问卷每天自我评估症状,持续3周。在第0天、第5天、第14天和第21天收集的鼻咽拭子上通过RT-PCR测量病毒载量。另外对SARS-CoV-2进行数字液滴PCR。
结果:总体上COVID-19受试者恢复了活动组中完成日常活动的能力(-1.6天,p=0.0487),味道较早改善(-2天,p=0.0404)。在D0时出现严重鼻部症状的COVID-19受试者表现出最早的失语症消退(-5.2天,p=0.0281),鼻后滴注(-4.1天,p=0.0102),面部疼痛/沉重(-4.5天,p=0.0078),头痛(-3.1天,p=0.0195),喉咙痛(-3.3天,p=0.0319),呼吸困难(-3.1天,p=0.0195),胸部充血(-2.8天,p=0.0386)和食欲不振(-4.5天,p=0.0186)用鼻腔冲洗。在URTIS主题中,鼻漏的较早解决(-3.5天,p=0.0370),鼻后滴注(-3.7天,p=0.0378),和总体疾病(-4.3天,p=0.0248)用鼻腔冲洗报告。向更严重的COVID-19的演变在活动期比对照组更低,在最年轻的受试者中病毒载量较早减少(第5天≥1.5log10拷贝/10000个细胞:88.9%vs62.5%,p=0.0456)。在活跃的群体中,在具有Delta变异的受试者中,SARS-CoV-2阳性家庭接触的百分比(0-10.7%)与对照组(3.2-16.1%)相比较低(p=0.0413)。
结论:该试验显示了海水鼻腔冲洗在COVID-19和URTI中的有效性和安全性。
背景:试验注册表ClinicalTrials.gov:NCT04916639。注册日期:04.06.2021。
OBJECTIVE: The objective was to assess the efficacy of seawater nasal wash on symptom duration, intranasal viral load, household transmission in COVID-19 and URTIs.
METHODS: This prospective, randomized, controlled, multicentric, parallel study included 355 mild/moderate COVID-19 and URTI adults with rhinologic symptoms ≤ 48h. Active group performed 4-daily nasal washes with undiluted isotonic seawater versus control group (without nasal wash). Symptoms were self-assessed daily using the WURSS-21 questionnaire for 3 weeks. Viral load was measured by RT-PCR on nasopharyngeal swabs collected on Day 0, Day 5, Day 14 and Day 21. Digital droplet PCR was additionally performed for SARS-CoV-2.
RESULTS: Overall COVID-19 subjects recovered earlier the ability to accomplish daily activities in the active group (- 1.6 day, p = 0.0487) with earlier improvement of taste (- 2 days, p = 0.0404). COVID-19 subjects with severe nasal symptoms at D0 showed the earliest resolution of anosmia (- 5.2 days, p = 0.0281), post-nasal drip (- 4.1 days, p = 0.0102), face pain/heaviness (- 4.5 days, p = 0.0078), headache (- 3.1 days, p = 0.0195), sore throat (- 3.3 days, p = 0.0319), dyspnea (- 3.1 days, p = 0.0195), chest congestion (- 2.8 days, p = 0.0386) and loss of appetite (- 4.5 days, p = 0.0186) with nasal wash. In URTIs subjects, an earlier resolution of rhinorrhea (- 3.5 days, p = 0.0370), post-nasal drip (- 3.7 days, p = 0.0378), and overall sickness (- 4.3 days, p = 0.0248) was reported with nasal wash. Evolution towards more severe COVID-19 was lower in active vs control, with earlier viral load reduction in youngest subjects (≥ 1.5log10 copies/10000 cells at Day 5: 88.9% vs 62.5%, p = 0.0456). In the active group, a lower percentage of SARS-CoV-2 positive household contacts (0-10.7%) was reported vs controls (3.2-16.1%) among subjects with Delta variant (p = 0.0413).
CONCLUSIONS: This trial showed the efficacy and safety of seawater nasal wash in COVID-19 and URTIs.
BACKGROUND: Trial registry ClinicalTrials.gov: NCT04916639. Registration date: 04.06.2021.