A multicentric, longitudinal study on measurement of Immune Responses in Multisystem Inflammatory Syndrome in Children (MIS-C)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Plasma cytokines, sC5b-9 and anti SARS-CoV-2 IgG and neutralizing antibody levels along with clinical correlation may help diagnose and differentiate MIS-C from other conditions with overlapping clinical features like Kawasaki disease.
研究概览
简要总结
Background: Multisystem inflammatory syndrome in children (MIS-C) is a hyperinflammatory condition that is being reported in regions with receding SARS-CoV-2 infection peaks. The pathophysiology of MIS-C has not been explored much. Here, in such cases we will be profiling aberrant immune activation and its alteration with therapy.
Novelty: Measuring plasma levels of a broad range of pro-inflammatory biomarkers may not only help in understanding the pathophysiology of MIS-C but also differentiate it from similar hyperinflammatory conditions like Kawasaki disease. None of the prior studies have looked at the cytokine responses before and after the therapeutic intervention. Also, deeper immunophenotyping is required in different geographies where comorbidities and genetic background differ and may have a role to play in the prognosis. There is a dearth of Indian data on immune responses in MIS-C.
Objectives: To measure the immune responses in MIS-C patients at two time points, before and after therapeutic intervention and compare it with the control groups.
Methods: Study and control subjects in the age-group 0 -19 years, fulfilling the inclusion and exclusion criteria will be enrolled. After a detailed clinical evaluation, the following tests will be done:
a. ELISA to detect IgG antibodies against SARS-CoV-2 virus
b. Surrogate assay for the detection of SARS-CoV-2 neutralizing antibodies
c. Soluble C5b-9 assay by ELISA
d. Proinflammatory biomarkers multiplex assay
Expected outcome: Plasma cytokines and other biomarkers, sC5b-9 and anti SARS-CoV-2 IgG and neutralizing antibody levels along with clinical correlation may help diagnose and differentiate MIS-C from other conditions with overlapping clinical features like Kawasaki disease. It may also help in the prognostication. Assessing a wider range of biosignatures may also give a better understanding of the pathophysiology of this hyperinflammatory condition.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 19.00 Year(s)（—）
- 性别
- All
入选标准
- •Study group: Patients diagnosed to be MIS-C cases by the treating physicians and co-investigators at the three collaborating centres (Kasturba Medical College, Manipal; Kasturba Medical College, Mangalore and Ramaiah Medical College, Bangalore) as per the WHO case definition.
- •Control groups: There will be three sub-groups in this: A) SARS-CoV-2 RT PCR positive patients in the age group, 0 – 19, not fitting into the WHO case definition of MIS-C.
- •B) Age matched healthy controls who are negative for SARS-CoV-2 RT-PCR and do not have signs and symptoms of any ongoing infection.
- •C) Children were classified as having complete/incomplete Kawasaki Disease (KD) by using American Heart Association criteria.
排除标准
- •Subjects on immunomodulatory therapy for samples obtained following the first visit to the treating physician.
结局指标
主要结局
Plasma cytokines, sC5b-9 and anti SARS-CoV-2 IgG and neutralizing antibody levels along with clinical correlation may help diagnose and differentiate MIS-C from other conditions with overlapping clinical features like Kawasaki disease.
时间窗: At first visit and follow up after 1 month
次要结局
- Understand the pathophysiology of MIS-C(At first visit and follow up after 1 month)