Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Clinical risk factors of acute respiratory infection due to COVID-19 in children.
研究概览
简要总结
Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19.
Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future.
Primary Objective
- To determine the clinical characteristics and outcomes of Covid-19 in children.
- To characterize the clinical risk factors of Covid-19 in children..
Secondary Objectives
- To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children.
- To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective
详细描述
Nasal swabs will be collected from positive patient participants on Day 0. Timing of follow-up swabs will be guided by standard of care procedures.
Whole blood will be collected at Days 0. Follow-up blood sampling will be guided by standard of care procedures. Samples will be stored at -80oC.
Nasal swabs and whole blood will only be obtained at the same time standard of care procedures are performed. If a patient is not getting a blood draw, no sample will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Participant Inclusion Criteria:
- •Less than 24 years old at the time of enrollment on study.
- •St. Jude patients with laboratory confirmed Covid-19.
排除标准
- 未提供
研究组 & 干预措施
Positive COVID-19
Baseline and Day 28: Respiratory and Whole blood Samples Collected, Days 7 and 14: Respiratory Samples Collected
Monthly follow-up until Covid-19 is negative: Respiratory and Whole Blood Samples Collected
Negative COVID-19
Baseline and Day 28: Respiratory and Whole blood Samples Collected, Days 7 and 14: Respiratory Samples Collected
结局指标
主要结局
Clinical risk factors of acute respiratory infection due to COVID-19 in children.
时间窗: Baseline-day 60
Pearson or Spearman's correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.
Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.
时间窗: Baseline-Day 60
Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.
次要结局
- Immunologic response to acute respiratory infection due to COVID-19 in children.(Baseline-Day 60)
- Duration of viral shedding and evolution in children longitudinally.(Baseline-Day 60)
- Immunologic response to acute respiratory infection due to COVID-19 in children.(Baseline-day 60)