SARS-CoV2 Infection Clinical Trial
— COVID-19Official title:
A Cross Sectional Study of the Systems Immunology and Viral Diversity of SARS-CoV2 Infection, COVID-19 Disease and Multisystem Inflammatory Syndrome in Children
Rationale: Severe Acute Respiratory Syndrome - Coronavirus - 2 (SARS-CoV2) and its related Coronavirus Disease - 19 (COVID-19) has become a health emergency worldwide. The medical community has been concerned since the beginning of the outbreak about the potential impact of COVID-19 in children, especially in those with underlying chronic diseases. Fortunately, COVID-19 has been reported to be less severe in children than in adults. Unfortunately, a new multisystem inflammatory syndrome apparently related to infection with SARS-CoV-2 has recently been reported in older children (known as MIS-C), manifested by severe abdominal pain, cardiac dysfunction and shock. However, the SARS-CoV2 infection and the underlying immunology of COVID-19, its correlation with disease severity and MIS-C in children is not fully explored. Objectives: To perform systems immunology and strain diversity among SARS-CoV2 and MIS-C infected children. Study design: Cross sectional study. Study population: Children attending outpatients units and admitted in wards in pediatric hospitals in Chennai. Main study parameters/endpoints: Immune responses in children with SARS-CoV2 infection and multisystem inflammatory syndrome in children (MIS-C) infection and its association of SARS-CoV2 viral diversity.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Year to 15 Years |
Eligibility | Inclusion Criteria: - Children between 1 to 15 years of age - Willing to provide informed consent (parents)/assent - For Group 1 - Positive or Negative for COVID-19 by RT-PCR but positive for SARS-CoV2 IgG - For Group 2 - Positive for COVID-19 by RT-PCR but negative for SARS-CoV2 IgG - For Group 3 - Positive for COVID-19 by RT-PCR or positive for SARS-CoV2 IgG antibody - For Group 4 - Control children who are negative for both RT-PCR and IgG antibody Exclusion Criteria: - Severely immunocompromised or anemic (WHO criteria in children) or malnourished - History of any illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the participant's participation in the protocol, or compromise the scientific objectives |
Country | Name | City | State |
---|---|---|---|
India | National Institute for Research in Tuberculosis | Chennai | Tamilnadu |
Lead Sponsor | Collaborator |
---|---|
Tuberculosis Research Centre, India | National Institutes of Health (NIH) |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterization of immune responses | Immune responses in children with SARS-CoV2 infection and multisystem inflammatory syndrome in children (MIS-C) infection and its association of SARS-CoV2 viral diversity | 6 months |
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