Effect of Nasopharyngeal Wash With Normal Saline on SARS-CoV2 Viral Load: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- SARS-CoV2 viral load
研究概览
简要总结
Although great progress has been made over the past 2 years in the scientific understanding of the biology, epidemiology, and pathogenesis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), case morbidity and fatality rates remain a great concern and continue to challenge the healthcare resources worldwide as novel variants emerge. There is therefore an urgent need for affordable and readily available strategies to reduce viral transmission. Previous studies in non coronavirus disease 2019 (COVID-19) patients have demonstrated that administration of low-salt (isotonic but 0.0375% Na) and isotonic saline (0.9% Na) solutions has been associated with an immediate, significant reduction in the microbial antigens and a related decline of microbial burden. The primary aim of the present study is to determine the effect of nasal washes with normal saline 0.9% on nasopharyngeal viral load in hospitalized patients with COVID-19 pneumonia. The secondary aim is to examine if this effect influences escalation to high flow nasal oxygen or non-invasive ventilation and admission to ICU in patients with COVID-19 pneumonia.
详细描述
Investigators will perform a prospective, randomized, pilot, controlled study in 50 patients with confirmed COVID-19 pneumonia. All patients will be treated with the standard protocol of care for COVID-19 at the Department of Infectious Diseases and will be randomized into one of two groups with the method of sequentially numbered, opaque, sealed envelopes, the normal saline group (will receive normal saline 0.9% solution for nasopharyngeal wash) and the control group (no treatment). In all patients, an initial baseline nasopharyngeal swab will be obtained at admission and will be placed in a sterile bottle of virus transport medium for SARS-CoV2 nucleic acid detection (day 1). Then, an educational review of nasopharyngeal wash technique will be performed. Patients from the normal saline group will be provided with eight 10 mL sterile bottles of sodium chloride 0.9% (NaCl 0.9%) solution and will be advised to perform nasopharyngeal wash with 10 ml of solution to each nostril, every 4 hours for a 16-hour period. Twenty-four hours after the baseline nasopharyngeal swab, and 8 hours after the last nasopharyngeal wash, a second nasopharyngeal swab will be collected for measurement of the viral load (day 2). All nasopharyngeal swabs will be collected by a physician blinded to group allocation and will be collected from the same nostril for each patient. Each sample will be tested at most up to 12 hours following collection. Patients demographic and clinical information will be recorded at admission [need for escalation to high flow nasal cannula (HFNC) or non invasive ventilation (NIV). Disease-related symptoms and potential adverse effects related to use of normal saline will also be monitored. All patients will be followed until hospital discharge, intensive care unit (ICU) admission or death. Those that will be discharged will be reexamined 14 days after hospital discharge for real-time polymerase chain reaction (RT-PCR). Manual chart review will be used to gather details of the laboratory studies, course, and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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
- •adult patients hospitalized primarily for COVID-19 pneumonia
- •confirmed SARS-CoV2 infection diagnosed through RT-PCR test of nasopharyngeal samples
排除标准
- •patients with confirmed SARS-CoV2 infection who were not primarily admitted for COVID-19 pneumonia
- •patients with use of intranasal sprays for at least two weeks prior to study enrollment
- •sinonasal surgery within 3 months prior to study enrollment
- •patients with sinusitis
- •inability to perform nasopharyngeal wash
- •participation in other trials
结局指标
主要结局
SARS-CoV2 viral load
时间窗: 24 hours
SARS-CoV2 viral load in nasopharyngeal swab in hospitalized patients with COVID-19 pneumonia
次要结局
- Need for escalation to HFNC / NIV, ICU admission(From date of randomization until hospital discharge, ICU admission or date of death from any cause, whichever came first assessed up to 3 months)
研究者
Ioannis Pantazopoulos
Assistant Professor of Emergency Medicine
Larissa University Hospital