Status:
RECRUITING
MISC COVID-19 Study in Pediatric Population
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
SARS-CoV2 Infection
Multisystem Inflammatory Syndrome in Children
Eligibility:
All Genders
1-15 years
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 c...
Detailed Description
Scientific Background: COVID-19 is a global health crisis. The clinical characteristics, disease progression and outcome in children and young adults appear significantly milder compared to older ind...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04844242
Start Date
December 23 2020
End Date
December 31 2024
Last Update
May 30 2024
Active Locations (1)
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1
National Institute for Research in Tuberculosis
Chennai, Tamil Nadu, India, 600031