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临床试验/NCT04838834
NCT04838834已完成不适用

Monitoring Serologic Response to SARS-COV-2 / Coronavirus Disease 2019 (COVID-19) in Children, Adolescents, and Young Adults Receiving Biologic Therapies (RECONN)

Connecticut Children's Medical Center1 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
472
试验地点
1
主要终点
Presence of anti-SARS-CoV-2 Immunoglobulin G (IgG)

研究概览

简要总结

Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. Whether children and young adults with inflammatory bowel disease (IBD) or juvenile idiopathic arthritis (JIA) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from COVID-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (MISC), is entirely unclear. This research focuses on the heretofore uncharacterized immune response to SARS-CoV-2 infection in children and young adults with IBD or JIA who are receiving maintenance immunosuppressive biologic therapies. Given the large Connecticut based infusion program, in a region of the United States with a recent large outbreak of COVID-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. The investigators will longitudinally determine antibody development and durability to SARS-CoV-2 in approximately 450-500 children and young adults with IBD or JIA receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. This period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-SARS CoV-2 vaccines. The specific aim is to study the acute and convalescent antibody responses to SARS-CoV-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for IBD and JIA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 27 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 2 to 27 years inclusive
  • Patients receiving biologic infusions for inflammatory or rheumatologic disorders at the Connecticut Children's Infusion Center, at a minimum frequency of 2 infusions over a 4 month period
  • Consent/assent as indicated
  • Have vein access placement as standard of care

排除标准

  • Patient and/or parent/legal guardian refused participation
  • Inability to draw requisite blood sample for serum collection

结局指标

主要结局

Presence of anti-SARS-CoV-2 Immunoglobulin G (IgG)

时间窗: At the time of infusions for up to 2 years

次要结局

  • Presence of anti-SARS-CoV-2 IgG neutralizing antibodies(At the time of infusions for up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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