Observing COVID-19 effects in children
A Cross Sectional Study of the Systems Immunology and Viral Diversity of SARS-CoV2 Infection, COVID-19 Disease and Multisystem Inflammatory Syndrome in Children
Tuberculosis Research Centre, India · NCT04844242
This study looks at how COVID-19 affects children, especially those with a serious condition called MIS-C, to see how their immune systems respond and how different virus strains might play a role.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 1 Year to 15 Years |
| Sex | All |
| Sponsor | Tuberculosis Research Centre, India (other gov) |
| Locations | 1 site (Chennai, Tamil Nadu) |
| Trial ID | NCT04844242 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the immunological responses and strain diversity of SARS-CoV-2 in children, particularly focusing on those affected by Multisystem Inflammatory Syndrome in Children (MIS-C). It will involve a cross-sectional analysis of children aged 1 to 15 years, categorizing them based on their COVID-19 test results and antibody presence. The study seeks to understand the correlation between SARS-CoV-2 infection and the severity of symptoms in pediatric patients, as well as the potential underlying immunological factors. By gathering data on these aspects, the research aims to fill gaps in knowledge regarding COVID-19's impact on children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 15 years with varying COVID-19 test results and antibody statuses.
Not a fit: Patients who are severely immunocompromised, anemic, or malnourished may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of COVID-19 in children and improve management strategies for those affected by MIS-C.
How similar studies have performed: Other studies have explored COVID-19 in children, but this specific focus on MIS-C and immunological responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chennai, Tamil Nadu
- National Institute for Research in Tuberculosis — Chennai, Tamil Nadu, India (RECRUITING)
Study contacts
- Study coordinator: PAVAN KUMAR, PhD
- Email: pavankumarn@nirt.res.in
- Phone: 9940292543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SARS-CoV2 Infection, Multisystem Inflammatory Syndrome in Children