Hypertonic Saline Nasal Irrigation and Gargling (HSNIG) for Suspected COVID-19: Pragmatic, Web-based Bayesian Adaptive Randomised Controlled Trial in Pakistan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 405
- 试验地点
- 2
- 主要终点
- Time to resolution of symptoms
研究概览
简要总结
Nasal washing (washout) followed by gargles with hypertonic saline (HSNIG) is believed to be effective in reducing the duration of illness in those with clinically suspected or confirmed COVID-19 being managed at home, and also is effective in reducing complications of COVID-19 and onward household transmission.
This study plans to investigate whether the use of HSNIG performed by adults with symptoms consistent with COVID-19 reduces the duration of symptoms when compared to participants managed using standard care.
详细描述
BACKGROUND
Analysis of data from the recent "Edinburgh and Lothians Viral Intervention Study" (ELVIS) pilot randomized controlled trial (RCT) indicates that hypertonic saline nasal irrigation and gargling (HSNIG) reduced the duration of coronavirus upper respiratory tract infection (URTI) by an average of two-and-a-half days. As such, it may offer a potentially safe, effective and scalable intervention in those with Coronavirus Disease-19 (COVID-19) following infection with the beta-coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
The researchers recently reported that epithelial cells mount an antiviral effect by producing hypochlorous acid (HOCl) from chloride ions. HOCl is the active ingredient in bleach. Epithelial cells have this innate antiviral immune mechanism to clear viral infections. Since bleach is effective against all virus types, it was tested to see whether a range of DNA, RNA, enveloped and non-enveloped viruses were inhibited in the presence of chloride ions supplied via salt (NaCl). All the viruses tested were inhibited in the presence of NaCl. The human viruses which were tested included: DNA/enveloped: herpes simplex virus; RNA/enveloped: human coronavirus 229E (HCoV-229E), respiratory syncytial virus, influenza A virus; and RNA/non-enveloped: coxsackievirus B3.
In COVID-19, high titers of SARS-CoV-2 are detectable in the upper respiratory tract of asymptomatic and symptomatic individuals. The titers are higher in the nose than the throat suggesting measures that control the infection and viral shedding will help reduce transmission.
Till the time a significant proportion of the world population is vaccinated against COVID-19, a safe and effective intervention is needed that can be implemented globally. The in-vitro data gives the evidence that NaCl has an antiviral effect that works across viral types. The findings from this post-hoc analysis of ELVIS need to be interpreted with caution. These data do however suggest that HSNIG may have a role to play in reducing symptoms and duration of illness in COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •Those living within larger cities of Pakistan (for laboratory access)
- •Those self-isolating at home within 5 days of the start of the illness with:
- •Clinical symptoms suggestive of COVID-19 (i.e. those who have at least one of the following symptoms: Respiratory symptoms, such as cough and shortness of breath; Fever; Muscle pain; Headache; Sore throat; New loss of taste or smell; Severe fatigue; Nausea or vomiting; Diarrhoea and Congestion or runny nose OR
- •Those with virologically confirmed SARS-CoV-2 infection and clinical symptoms indicative of COVID-19 (as detailed in (a) above).
- •Provision of informed consent
排除标准
- •Onset of illness (symptoms) more than 5 days
- •Inability to consent
- •Age less than 18 years.
- •Pregnancy
- •Immunosuppressed patients Inability to perform HSNIG
- •Those taking part in another interventional medical trial
- •Those with suspected/confirmed COVID-19 in whom hospital admission is recommended
- •Those who do not have access to email / internet
- •Those living in a household with another person currently participating in this study
- •Those who have not provided consent to take part
结局指标
主要结局
Time to resolution of symptoms
时间窗: 2 weeks
Self-reported time to resolution as assessed by completion of the validated self-reported UK-adapted short form of the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) which will be used to collect daily symptom data
次要结局
未报告次要终点
研究者
Osman Yusuf
Chief Consultant
The Allergy and Asthma Institute, Pakistan