Investigating the Therapeutic Role of Topical Medical Treatment in Oral and Nasal Cavities on the Patients With Positive Severe Cute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8
研究概览
简要总结
The goal of this study is to recruit confirmed Covid-19 patients, to evaluate whether the topical anti-septic can improve clinical outcome in early Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infection. During the global pandemic period, an effective and highly available method once be identified, it will reduce the risk of disease transmission and lower the medical burden.
详细描述
Oral and nasal disinfection, a simple method with the application of commonly used antiseptic agents is frequently performed in the otolaryngology and dental practice. The ability to deactivate viral particles with a good safety profile may be an important benefit in the control of viral proliferation and shedding. Actually, multiple anti-septic agents demonstrated virucidal properties against SARS-CoV-2 in several in vitro studies. Among these, Povidone-Iodine (PVP-I), common usage in otolaryngology operation and topical therapy, showed high virucidal properties (0.45% PVP-I, throat spray, 4-log drop in viral load) and of great safety. There is also evidence that topical usage of saline can decrease the severity of upper respiratory tract infection. In addition, carrageenan, a sulphated polysaccharide purified from red marine algae, had shown efficacy in inhibiting multiple viruses, including in vitro studies of SARS-CoV-2. Some randomized controlled trials had also shown their abilities in improving patients' symptoms with a good safety profile. Multiple international organizations are conducting relating randomized clinical trials to evaluate whether the topical anti-septic improves clinical outcomes after early SARS-CoV-2 infection. The added value of topical antiseptic agents may be beneficial in improving symptoms, reducing viral load and alleviating the rate of disease progression. Due to relatively low risk, well-toleration to the general population, and highly available characteristics, the potential benefits of these agents deserve more attention.
The goal of this study is to investigate the changes in clinical symptoms and sequential laboratory data in confirmed COVID-19 adult patients at the early disease stage. By applying topical anti-septic which is frequently used in otolaryngology procedures, the investigators will evaluate the impact of this intervention on the symptoms, viral load and the rate of disease progression. During the global pandemic period, an effective and highly available method once be identified, it will reduce the risk of disease transmission and lower the medical burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age older than 20 years of age
- •admission with a confirmed positive test for SARS-CoV-2 infection by reverse transcription polymerase chain reaction (RT- PCR)
- •disease onset (start of COVID-19 symptom and PCR test) for ≤ 120 hours
- •available informed consent of this study.
- •Full COVID-19 vaccination(at least after 2nd dose of TFDA-approved vaccine 14 days)
排除标准
- •receiving oxygen supply before intervention
- •known intolerance/allergy to the study drugs
- •sinus/oral operation within 30 days of the beginning of the study
- •using intranasal medication before randomization
- •no available informed consent
- •inability to self-care or reply to questionnaire
研究组 & 干预措施
Topical medical treatment
Intranasal spray and oral gargling
干预措施: Carrageenan nasal spray and 1% PVP- mouthwash and gargle (Drug)
结局指标
主要结局
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8
时间窗: 7 days
the mean change of viral titers of COVID-19 between Day 1 and Day 8 by RT-PCR test
次要结局
- length of hospitalization(up to 14 days)
- days of discharge(up to 30 days)
- number of days in an ICU(up to 14 days)
- symptoms related to COVID-19(10 days)
- frequency of adverse effects of interest after anti-septic(10 days)
- number of days Non Invasive Ventilation (NIV) was required during hospitalization(up to 14 days)
- mortality rates(up to 30 days)