COVID-19
A Cross Sectional Study of the Systems Immunology and Viral Diversity of SARS-CoV2 Infection, COVID-19 Disease and Multisystem Inflammatory Syndrome in Children
Sponsor study identifier
Secondary identifiers
OTHER · NIRT-IEC
observational
180
1 country
1
Study Start
December 23, 2020
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 23, 2020
Actual (reported)April 13, 2021
Actual (reported)April 14, 2021
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Prior SARS-CoV2 infection as defined by being positive for IgG
COVID-19 disease as defined as children positive by RT-PCR
Children with MIS-C according to the WHO or CDC criteria
Control children who are negative for both RT-PCR and antibody
Children attending outpatient clinics and admitted in the wards of Institute Of Child Health and Hospital for Children, Rainbow Childrens Hospital and Dr. Mehta's Childrens Hospitals, Chennai.
National Institute for Research in Tuberculosis
Chennai, Tamil Nadu, 600031, India
Rajamanickam A, Nathella PK, Venkataraman A, Varadarjan P, Kannan S, Pandiarajan AN, Renji RM, Elavarasan E, Thimmaiah A, Sasidaran K, Krishnamoorthy N, Natarajan S, Ramaswamy G, Sundaram B, Putlibai S, Hissar S, Selladurai E, Uma Devi KR, Nutman TB, Babu S. Unique cellular immune signatures of multisystem inflammatory syndrome in children. PLoS Pathog. 2022 Nov 2;18(11):e1010915. doi: 10.1371/journal.ppat.1010915. eCollection 2022 Nov.
Blood, nasopharyngeal swab
First Submitted
April 13, 2021
First Posted
April 14, 2021
Study Start
December 23, 2020
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
Contact the study team to confirm eligibility.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 30, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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