Clinical Efficacy of Xylitol Based Nasal Spray for the Treatment of Mild COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Xlear, Inc
- 入组人数
- 80
- 主要终点
- Viral load reduction
研究概览
简要总结
Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. The nasal spray is comprised of xylitol and GSE (Grapefruit Seed extract) which provides antibacterial properties as well as preventing viral adhesion in the nasal passage. Studies into Xlear's antiviral effects on SARS-CoV-2 are currently ongoing but hypothetically, a Xylitol Based Nasal spray may prove to be a useful and inexpensive treatment for COVID-19 infection.
详细描述
- BACKGROUND and RATIONALE
In the wake of the Coronavirus disease 2019 (COVID-19) pandemic, worldwide healthcare has rapidly evolved in response. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel virus responsible for COVID-19, which at the most severe end of the spectrum of disease can require hospitalisation or ICU admission. Preventative measures are currently being taken with numerous vaccination programs across the world. However, there is currently no established treatment for mild COVID-19 infection, i.e., symptomatic infection not requiring hospitalisation, which makes up a significant proportion of cases. Xylitol has shown promising results in combating SARS-CoV-2 in vitro and this study aims to explore whether Xlear's Xylitol based Nasal Spray has an effect in vivo.
1.1 COVID-19 Infection SARS-CoV-2 is a positive-sense, single-strand RNA virus comprised of four structural proteins: Nucleocapsid (N) protein, Membrane (M) protein, Spike (S) protein and Envelope (E) protein. These structural proteins play an important role in receptor binding, transcription, replication and assembly of the virus in host cells (Boopathi et al., 2020). The nasal epithelium acts as the primary site for SARS-CoV-2 binding to angiotensin converting enzyme-2 (ACE2) - the receptor responsible for COVID-19 infection (Zhou et al., 2020). With nasal carriage playing a vital role in transmission, drugs administered intranasally could be a viable therapeutic option (Sungnak et al., 2020).
1.2 Drug: Xylitol Xylitol is a sugar alcohol derived from plants. It is used in the dental profession to prevent plaque build-up and inhibit enamel demineralisation by interfering with the metabolism of Streptococcus mutans, causing cell death and thus preventing dental caries (Janakiram et al., 2017). Xylitol not only demonstrates antimicrobial behaviour but can also modulate immunity and contribute to wound healing (Salli et al., 2019).
1.2.1 Xylitol and Respiratory Tract Infections Xylitol's inhibitory effect on Streptococcus mutans growth has prompted more research into its interactions with other nasopharyngeal pathogens responsible for respiratory tract infections. An in vitro study into alpha-haemolytic Streptococcus pneumoniae and beta-haemolytic Streptococci treated with 1% and 5% xylitol showed statistically significant inhibition of growth over a 24-hour incubation period (Kontiokari et al., 1999).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Subjects will be randomized 1:1 to receive the Xylitol Based Nasal Spray or a matching saline base placebo. This is a double blinded study. The Nasal Spray Kits will be randomized and allocated to patients in chronological order.
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
- •Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
- •Adult aged ≥18 years old with at least two comorbidities: diabetes (type 1 &2), obesity (BMI >30), hypertension, chronic heart disease, chronic pulmonary disease, chronic liver disease.
- •Internet access and capability and willingness to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
- •COVID-19 infection confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab;
- •Specimen collected within the past 48 hours;
- •Mild COVID-19 symptoms which may include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath
排除标准
- •Not fit to consent and unable to follow the protocol;
- •Age <18 years;
- •Current tracheostomy or laryngectomy;
- •Hypersensitivity to the active substance or to any of the excipients;
- •Concomitant respiratory therapy such as oxygen or ventilator support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
- •Need for hospitalisation for any reason;
- •Inability to safely self-administer nasal spray
- •Any clinical contraindications, as judged by the Qualified Medical Practitioner;
- •Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
- •Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
- •Lactating, pregnant or planning to become pregnant during the study period;
- •Diagnosed with prior COVID-19 infection (>48 hours from the time the test is reported prior to the time of screening).
- •No relevant comorbidity or only one comorbidity
结局指标
主要结局
Viral load reduction
时间窗: Day 0 (baseline), Day 2, 4 6 and 8
The between-groups difference in log-viral load over the total treatment period
次要结局
- Undetectable viral load(baseline to Day 2, 4, 6 and 8)
- Hospitalization requirement(Baseline through Day 8)
- Reduction of clinical symptoms score(Baseline through Day 14)
- Safety of Nasal Spray(Baseline through Day 14)
- Tolerability of Nasal Spray(Baseline through Day 14)