Gastrointestinal Symptoms of SARS-CoV-2 Infection: a Prospective Multicentre Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease
研究概览
简要总结
The coronavirus disease 2019 (COVID-19) initially developed at the beginning of December 2019 in Whuan, Hubei province of China has spread all over the world. Beside the most common symptoms at onset of illness including fever, fatigue, dry cough, myalgia and dyspnoea, there are less common symptoms such as headache abdominal pain, diarrhoea, nausea and vomiting. The proportion of patients complaining gastrointestinal symptoms is variable between 3,4% and 17,0%. Interestingly, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) RNA has been reported to be detectable in 50% of patients' stool samples and in these patients around the 50% had diarrhoea.
SARS-CoV2 transmission has been reported to be through droplets. However, mounting evidence indicates that SARS-CoV2 has a tropism for the gastrointestinal tract and is excreted with faeces. Accordingly, a faecal-oral route of transmission of the virus has been recently postulated. Indeed, SARS-CoV2 binds to host ACE 2 receptors (ACE2) to entry into cells which are abundantly expressed by intestinal epithelial cells and regulate intestinal inflammation. Taken together, this evidence could provide a rational basis for the development of gastrointestinal symptoms reported by COVID19 infected patients.
Primary aim: to evaluate the prevalence and prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease Secondary aims
- to evaluate long term consequences of COVID-19 on gastrointestinal symptoms
- to evaluate long term consequences of COVID-19 on the development of post-infection irritable bowel syndrome (PI-IBS)
- to evaluate long term consequences of COVID-19 on the development of post-infection dyspepsia
- to assess the clinical and laboratory predictors (risk factors) of post-infection gastrointestinal symptom development
详细描述
The investigators propose a multicentre observational prospective study according to the clinical routine practice of coronavirus disease 2019 (COVID-19) patients. All patients will be clinically evaluated at admission according to standard clinical practice. All data present in the inpatient medical record will be used for the study.
The study cohort will be composed by consecutively enrolled COVID19 confirmed inpatients (case group) and COVID19 negative patients hospitalized for other reasons (controls group) referred to the participants centres from May 1, 2020.
Patient's follow up will start at discharge and will continue for 12 months.
Definitions Confirmed COVID19 cases The definitions of COVID19 state are according to the World Health Organization (WHO) document released in March 2020.
A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms. Patients categorized as suspect or probable COVID19 cases will be excluded from enrolment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥18 years and ≤85 years
- •Consecutive COVID19 confirmed patients (COVID +ve) (case group)
- •Consecutive hospitalized COVID19 negative patients (COVID -ve) (control group)
- •Ability to conform to study protocol
排除标准
- •Patients under mechanical ventilation
- •Patients unable to report required data
- •Current diagnosis of cancer
结局指标
主要结局
Prognosis of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease
时间窗: one month
For the prognosis, mortality rates (%) at one month will be evaluated.
Prevalence of gastrointestinal symptoms in patients admitted to hospital for COVID19 disease as assessed by GSRS questionnaire
时间窗: one month
For the primary aims of the study, the presence of gastrointestinal symptoms at admission and at follow-up made 1 month after discharge will be evaluated. In particular, the validated Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (a 7-points Likert scale) will be used to assess the prevalence of gastrointestinal symptoms.
次要结局
- Long term consequences of COVID-19 on gastrointestinal symptoms on the development of post-infection (PI) irritable bowel syndrome (IBS).(12 months)
- Identification of risk factors for post-infection gastrointestinal symptom development.(12 months)
- long term consequences of COVID-19 on gastrointestinal symptoms on the development of post-infection (PI) dyspepsia.(12 months)
研究者
Giovanni Barbara
Professor
University of Bologna