Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting
研究概览
简要总结
A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.
详细描述
This study is designed to allow immunosuppressed children, their parents or adult patients to self-record their experiences of COVID-19 and other viral respiratory illnesses. Patients, parents and of immunosuppressed patients and patients aged 16-17 yrs will be provided with online information and asked to fill in online questionnaires at baseline and weekly thereafter. Information collected includes medication, symptoms, contact with health care providers, test results and impact on daily activities. Data will be collected and analysed weekly to be able to monitor any potential risk factors for severe disease. This study is complementary to, and not overlapping with, the global ISARIC World Health Organisation protocol that will be studying COVID-19 cases admitted to all National Health Service (NHS) Trusts, including all children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •Children part: Parent of immunosuppressed patient aged <16 years or immunosuppressed patient aged 16-17 years
- •Adult part: Immunosuppressed patient aged >17 years
- •Family or themselves able to complete the questionnaire which will be in English (due to current resources available translation will not be possible)
- •Reliable access to the internet
排除标准
- •Unable to understand English
结局指标
主要结局
To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting
时间窗: 1 year
To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year
次要结局
- Number of children/adults tested positive for COVID19(1 year)
- Number of children/adults admitted in hospital because of COVID19(1 year)
- To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children(1 year)