Status:
COMPLETED
European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol. Covid-19
Lead Sponsor:
PENTA Foundation
Collaborating Sponsors:
Centre Hospitalier Universitaire Saint Pierre
University of Athens
Conditions:
Sars-Cov2 Antibodies in Children and Adolescents Living With HIV
Eligibility:
All Genders
Up to 24 years
Brief Summary
Scientific knowledge about the COVID-19 pandemic and the virus that is causing it (SARS-CoV-2) is developing rapidly, and the investigators have a clearer idea of the population groups who are at high...
Detailed Description
The study will be conducted within existing cohorts of children, adolescents and young adults living with HIV being followed up in several European countries and South Africa: the European Pregnancy a...
Eligibility Criteria
Inclusion
- \< 18 years at HIV diagnosis
- Current age under 25 years
- Attending routine HIV care in a participating clinic
- Currently in follow-up in CTAAC, a cohort which contributes to EPPICC, or another collaborating cohort
- If aged ≥16 years (or local legal adult age), willing and able to give informed consent to participate in the study
- If aged \<16 years (or local legal adult age), a parent/carer able to give informed consent for participating in the study (and, depending on local requirements, those aged ≥10 years, with capacity, to also provide assent).
- In addition, in South Africa HIV-uninfected adolescents will be eligible to participate in the study during planned study visits if they meet the following inclusion criteria:
- Current age under 25 years
- In follow-up in the CTAAC study
- If aged ≥18 years, willing and able to give informed consent to participate in the study
- If aged \<18 years, a parent/carer is able to give informed consent for participating in the study and participant willing and able to provide assent.
Exclusion
- Children and adolescents are ineligible if they are taking part in a COVID-19 / SARS-CoV-2 vaccine study at enrollment.
- However, should a participant who is enrolled in the EPPICC-SARS-CoV-2 study subsequently join a COVID-19 / SARS-CoV-2 vaccine study or receive a COVID-19 / SARS-CoV-2 vaccine, these are not reasons for exclusion from this study. Data will be collected on vaccine receipt and participation in vaccine studies.
Key Trial Info
Start Date :
October 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 9 2022
Estimated Enrollment :
906 Patients enrolled
Trial Details
Trial ID
NCT04726137
Start Date
October 14 2020
End Date
July 9 2022
Last Update
September 20 2024
Active Locations (7)
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1
Centre Hospitalier Universitaire Saint Pierre
Brussels, Belgium
2
"Agia Sophia" Children's Hospital of Athens, First Department of Paediatrics & Immunobiology & Vaccinology
Athens, Greece
3
University of Cape Town
Cape Town, South Africa
4
Hospital Sant Joan De Déu
Barcelona, Spain, 08950