European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol. Covid-19

NCT04726137 | Completed Results

• 1 other identifier: 17493/002
• Study Type: observational
• Target: 906
• Locations: 6 countries
• Sites: 7

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 higher risk of becoming infected, having serious illness, and dying. However, less is known about COVID-19 in children, adolescents and young adults living with HIV. It is not yet known whether, or how, HIV affects people's risk of being infected with the virus or becoming ill. This study aims to find out whether children and adolescents living with HIV have had the COVID-19 virus, even if they did not have symptoms and did not realise it at the time. When a person is infected with a virus, their immune system fights the infection. As a result, they produce proteins called antibodies, and it may take a few weeks for enough antibodies to be made to be detected by a blood test. These antibodies may help protect the person from getting the same infection again. This study wants to find out how many children and adolescents living with HIV across Europe and South Africa have antibodies to the COVID-19 virus. It wants to see if the proportion with antibodies is different in younger children compared to older adolescents and young adults, and whether it varies between different countries. Children and adolescents with HIV regularly attend hospital outpatient appointments, and during these appointments blood samples may be taken to monitor their health. This study will invite these patients to be tested for antibodies to the COVID-19 virus during their routine visit. The participants will be asked a few short questions about COVID-19 diagnoses in their household and other risk factors for exposure to the virus, and it will collect information on their HIV, medications and any other illnesses they may have. At their next routine clinic visit, approximately 6 months later, it will test them again for antibodies. Testing twice will let see how the percentage of children, adolescents and young adults with antibodies to the COVID-19 virus has changed over time. In South Africa, HIV-uninfected adolescents from a similar socioeconomic background to those living with HIV and recruited to the study will be invited to join this study, which will allow us to compare the prevalence of antibodies across the two groups. The information from this study will help scientists and healthcare workers care for children, adolescents and young adults living with HIV during the ongoing COVID-19 epidemic in the best possible way. Participants may be given their test results, together with information about what the result means, depending on the usual practice within their clinic.

Conditions

Sars-Cov2 Antibodies in Children and Adolescents Living With HIV

Keywords

HIV; COVID-19; Sars-Cov2; children; adolescents; paediatric; cohort; infectious diseases

Outcome Measures

Primary Outcomes (2)

• Number of Participants With at Least One Positive SARS-CoV-2 Antibody Test.

  Throughout follow-up (at baseline for participants with one sample only; median 6 months for those with two samples)

• Number of Unvaccinated Participants With at Least One Positive SARS-CoV-2 Antibody Test.

  Participants who have not received the SARS-CoV-2 vaccine at the time the sample was taken.

  Throughout follow-up (at baseline for participants with one sample only; median 6 months for those with two samples)

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Paediatric infectious disease clinics across Europe and ongoing study in South Africa

You may qualify if:

• \< 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).
• 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.

You may not qualify if:

• Children and adolescents are ineligible if they are taking part in a COVID-19 / SARS-CoV-2 vaccine study at enrollment.

Sponsors & Collaborators

• PENTA Foundation: lead
• Centre Hospitalier Universitaire Saint Pierre: collaborator
• University of Athens: collaborator
• University of Cape Town: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Sant Joan de Deu: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Northern Care Alliance NHS Group: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• CHIPS+ Cohort: collaborator
• University College, London: collaborator

Study Sites (7)

Centre Hospitalier Universitaire Saint Pierre

Brussels, Belgium

Location

"Agia Sophia" Children's Hospital of Athens, First Department of Paediatrics & Immunobiology & Vaccinology

Athens, Greece

Location

University of Cape Town

Cape Town, South Africa

Location

Hospital Sant Joan De Déu

Barcelona, 08950, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

CBO Perinatal Prevention of AIDS Initiative (PPAI)

Odesa, 65012, Ukraine

Location

University College London

London, WC1E 6BT, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Communicable Diseases

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Giorgia Dalla Valle
• Organization: Fondazione Penta ETS

giorgia.dallavalle@pentafoundation.org

393783022748

Study Officials

• Intira J Collins, PhD

  jeannie.collins@ucl.ac.uk

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 27, 2021
• Study Start: October 14, 2020
• Primary Completion: July 9, 2022
• Study Completion: July 9, 2022
• Last Updated: September 20, 2024
• Results First Posted: September 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); ZA (1); ES (2); GB (1); BE (1); UA (1)