Actively Recruiting

Age: 1Year - 15Years
All Genders
NCT04844242

MISC COVID-19 Study in Pediatric Population

Led by Tuberculosis Research Centre, India · Updated on 2024-05-30

180

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

Sponsors

T

Tuberculosis Research Centre, India

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

MISC COVID-19 Study in Pediatric Population

Who Can Participate

Age: 1Year - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institute for Research in Tuberculosis

Chennai, Tamil Nadu, India, 600031

Actively Recruiting

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Research Team

P

PAVAN KUMAR, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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