MISC COVID-19 Study in Pediatric Population

NCT04844242 | Recruiting DMC

• 1 other identifier: 2020 034
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV2 Infection; Multisystem Inflammatory Syndrome in Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Group 1

Prior SARS-CoV2 infection as defined by being positive for IgG

Group 2

COVID-19 disease as defined as children positive by RT-PCR

Group 3

Children with MIS-C according to the WHO or CDC criteria

Group 4

Control children who are negative for both RT-PCR and antibody

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tuberculosis Research Centre, India: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

National Institute for Research in Tuberculosis

Chennai, Tamil Nadu, 600031, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 36322537 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, nasopharyngeal swab

MeSH Terms

Conditions

COVID-19; pediatric multisystem inflammatory disease, COVID-19 related

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

PAVAN KUMAR, PhD

CONTACT

9940292543; pavankumarn@nirt.res.in

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 14, 2021
• Study Start: December 23, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)