Randomised Single Blinded Clinical Study of Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in severity of COVID-19 infection
研究概览
简要总结
Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal irrigation for 14 days, followed by a 14 day observation period. Irrigation will be performed with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients will be able to identify their treatments, but study staff will be blinded as to assignment.
详细描述
BACKGROUND/OBJECTIVE
The potential role of the microbiome in COVID-19 disease remains little explored, yert may offer an unique therapeutic opportunity for its treatment. Airway inflammation and microbiome dysbiosis is present in COVID-19 patients and is related to evolution. The limited information on airway inflammation in COVID-19 suggests greater inflammation, as assessed by serum markers of inflammation, is associated by more severe disease. Late cell-mediated T-cell activation is paradoxically accompanied by TLR expression downregulation, which contributes to dysfunctional immune regulation. Individual predisposition to heightened inflammatory responses may contribute to this.
The investigators believe this early TLR downregulation is an important feature of the disease, allowing the disease to reproduce unchecked and spread during a prolonged asymptomatic shedding period.
Immune-evasion strategies are common to several viral infections such as influenza, respiratory syncytial virus, and human rhinovirus, COVID-19 may exploit this as well.
Lung microbiome data in COVID-19 is limited, but a small dataset of 8 hospitalised cases has been reported from China suggests pulmonary inflammation can be influenced by the microbiome at the time of intubation, arguing the need for a more favorable upper airway microbiome.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Investigator responsible for product allocation and blinding is not in contact with study participant and will only be made aware of the process of their evolution in case of emergency.
Study personel in daily contact with the patient are unaware of the patient treatment assignement and are thus blinded.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-59 years
- •Positive diagnosis of COVID-19 infection less than 96 hours
- •Characteristic respiratory symptoms present but no more than mild to moderate
- •No need for oxygen
- •Temperature less than 38.0 ºC
- •Not presently being considered for hospitalisation or ICU admission
- •Able to perform nasal irrigation
- •Able to provide consent
- •Able to communicate with the study team by phone, text or email
排除标准
- •Patients with pre-existing conditions or demographic features placing them at increased risk of complications from COVID10 infection will not be included in this study. These will be considered exclusion factors, thus individuals will be questioned as to the presence or these factors during their telephone screening.
- •Respiratory disorders:
- •Asthma, Pre-existing COPD, bronchiectasis or cystic fibrosis
- •Hypertension
- •Cardiovascular disease:
- •Rhythm disturbances, recent (less than 6 months), angina pectoris cardiac insufficiency
- •Immunosuppressed patients (other than COVID-19 induced)
- •Primary immune deficiencies such as hypogammaglobulinemia or common variable immune deficiency (CVID)
- •Chemotherapy depressing the immune system
- •Immune suppressing medications such as prednisone, Imuran, or TNF inhibitors, or anti-rejection transplant drugs.
- •Solid organ transplant
- •Cancer under treatment or within five years (except basocellular skin cancers)
- •Pregnant or breastfeeding women or women unwilling to practice contraception as outlined in the study protocol for the duration of the study period.
- •Allergy to milk or its derivatives
结局指标
主要结局
Change in severity of COVID-19 infection
时间窗: 4 weeks
Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.
次要结局
- Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS).(4 weeks)
- Number of days where rescue medication is required(4 weeks)
- Number of days with any symptom of anosmia(4 weeks)