Sars-Cov2 Antibodies in Children and Adolescents Living With HIVSARS-Cov2NCT04726137
European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol. Covid-19
An observational study of Sars-Cov2 Antibodies in Children and Adolescents Living With HIV, run by PENTA Foundation at 7 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Sars-Cov2 Antibodies in Children and Adolescents Living With HIV
- How many people
- 906 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 14 Oct 2020to 9 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- All sexes
- Child, Adult
Study population: Paediatric infectious disease clinics across Europe and ongoing study in South Africa
Who may be able to join
- < 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Spain2 sites
Hospital Sant Joan De Déu
Barcelona, 08950
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Greece1 site
"Agia Sophia" Children's Hospital of Athens, First Department of Paediatrics & Immunobiology & Vaccinology
Athens
About this study
Official title: European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol
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.
Read more
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.
Read the 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 and Paediatric Infections Cohort Collaboration (EPPICC) Paediatric Study and the Cape Town Adolescent Antiretroviral Cohort (CTAAC). In CTAAC, adolescents without HIV are also enrolled and will be included in this study. For all participants, two blood samples will be taken at routine clinic visits approximately six months apart and tested for antibodies to SARS-CoV-2; clinical data and data on potential COVID-19 exposures will also be collected.
MAIN AIM OF THE STUDY The overall aim of this study is to describe the prevalence and distribution of antibodies to SARS-CoV-2 in children and adolescents living with HIV in Europe and South Africa.
Primary objective:
•To estimate prevalence of SARS-CoV-2 antibodies in the paediatric and adolescent HIV population and how this changes over time, overall and by key age groups and regions
Secondary objectives:
- To assess factors associated with presence of SARS-CoV-2 antibodies (including demographic factors, antiretroviral treatment, HIV-associated factors or co-morbidities and exposure to household members with COVID-19)
- To estimate the incidence of changes in antibody status to SARS-CoV-2 and associated factors
ENROLMENT Where feasible, all children and adolescents meeting the inclusion criteria and attending the participating clinics during the study period will be invited to take part; where this is not possible, a convenience sample of children and adolescents (e.g. those attending clinic on a specified day of the week) should be invited. The invitation to participate should be independent of the patient's probability of having been exposed to COVID-19. Participants enrolled in the EPPICC Paediatric Study or CTAAC will continue to be followed up as part of the ongoing study.
DATA COLLECTION The study will use data collected in the main EPPICC Paediatric study for participants attending clinics which participate in that study. This includes demographic data and clinical, therapeutic, laboratory and outcome information relating to HIV, COVID-19 and multi-system inflammatory syndrome in children (MIS-C). These data are extracted from clinic records and submitted as part of the main EPPICC study, and will be linked to data collected through the serology study.
Sites which are not members of the EPPICC network will submit equivalent data relating to the time of the two study visits for CLWHIV and HIV-uninfected adolescents.
Additionally, a short questionnaire will be completed by the participant (or their parent / carer) about potential exposures to COVID-19, including diagnoses in household members and known contacts.
For any participant with a record of a suspected or confirmed COVID-19 or MIS-C diagnosis, the cohort will be asked to complete an additional case record form providing details of the diagnosis (e.g. clinical features, hospital admissions, treatments and outcomes).
Cohorts will send pseudonymised electronic datasets to the MRC CTU at UCL. Transfer of data to the MRC CTU at UCL takes place using Galaxkey or an equivalent secure method such as UCL's REDCap server. Data will then be uploaded into a customised database.
LABORATORY TESTING Where sites are conducting serological testing as part of standard care, venous blood samples taken at each site will be transported to the laboratory(ies) routinely carrying out antibody testing for that site. Samples will be analysed with the tests used by each site in routine practice according to manufacturers' instructions or, if in-house tests are used, local SOPs/protocols.
At sites not offering routine serological testing, arrangements should be made with local laboratories for testing. There is strong preference for tests for IgG against the viral spike protein; however, it is recognised that there may be local considerations influencing the range of tests available across settings and results from other tests will be considered.
DISCONTINUATION OR EARLY WITHDRAWAL OF PARTICIPANTS Participants (or their parents/carers) may withdraw from the study at any time without providing a reason.
Participants wishing to withdraw from the study will be offered two options:
- Participants may withdraw from active follow-up (i.e. future study procedures) within this study but allow the retention and use of data already collected, and further linkage with other data sources as described in the Participant Information Sheet.
- Participants may withdraw completely from the study, in which case all data and samples collected (if not already tested) would be destroyed and no further follow-up or linkage would take place as part of this study.
Should a participant (or their parent / carer) lose the capacity to consent, they will be withdrawn from active follow-up and their data / samples retained and included in data linkages. Participants who withdraw for any reason will not be replaced.
All withdrawals will be recorded in the study database.
ANALYSIS PLAN Proportions with SARS-CoV-2 antibody at baseline and follow-up and the number/incidence of changes in antibody status between baseline and subsequent test will be estimated overall and by key patient characteristics, region, history of symptomatic COVID-19, contact with COVID-19 cases. Factors associated with the presence of SARS-CoV-2 antibody, changes in antibody status and any subsequent COVID-19 diagnosis (if numbers allow), will be explored using univariable and multivariable logistic and Poisson regression. Exposures of interest include age, sex, ART class and regimen (e.g. protease inhibitor- or tenofovir-based versus other), CD4 count, viral load, ethnicity, BMI-for-age z-score, co-infections (e.g. tuberculosis), co-morbidities and household size.
The association between HIV status and SARS-CoV-2 seropositivity, changes in antibody status and subsequent COVID-19 diagnosis will be assessed in the South African cohort (which includes HIV-uninfected children as well as CLWHIV) using similar methods.
If there is substantial variation in the type of antibody test used (anti-S versus anti-N), analyses will be stratified by type of test. For participants with positive results at both baseline and follow-up and if data allow, quantitative antibody results will be explored to qualitatively describe the possible contribution of re-exposure boosting antibody responses (versus persistence of an existing response).
In sensitivity analyses, we will investigate the implications of misclassification of results due to imperfect sensitivity / specificity of the serological tests used.
COMPLIANCE The study will be conducted in compliance with the approved protocol, the Declaration of Helsinki 1996, the principles of Good Clinical Practice as laid down by the ICH topic E6 (R2), General Data Protection Regulation and the UK Data Protection Act 2018 (DPA number: Z6364106), and the UK Policy Framework for Health and Social Care Research.
Each cohort is responsible for ensuring compliance with local and national regulatory and ethical processes, and data protection.
- Keywords
- HIV, COVID-19, Sars-Cov2, children, adolescents, paediatric, cohort, infectious diseases
- Medical subject headings
- COVID-19, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Positive SARS-CoV-2 Antibody Test.
Measured: 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.
Measured: Throughout follow-up (at baseline for participants with one sample only; median 6 months for those with two samples)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start14 Oct 2020
- Primary completion9 Jul 2022
- Study completion9 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sars-Cov2 Antibodies in Children and Adolescents Living With HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre, University of Athens, University of Cape Town, Hospital General Universitario Gregorio Marañon, Hospital Sant Joan de Deu, Great Ormond Street Hospital for Children NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Northern Care Alliance NHS Group, University Hospital Birmingham NHS Foundation Trust, Imperial College Healthcare NHS Trust, King's College Hospital NHS Trust, St George's University Hospitals NHS Foundation Trust, CHIPS+ Cohort, University College, London
- Responsible party
- Sponsor
- Investigators
- Intira J Collins, PhD, Study director, jeannie.collins@ucl.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726137
- Sponsor's protocol ID
- 17493/002
- Acronym
- SARS-Cov2
- Status last verified
- May 2024
- First submitted
- 18 Jan 2021
- Last updated
- 20 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol
- ClinicalTrials.gov ID
- NCT04726137
- Acronym / sponsor ID
- SARS-Cov2 / 17493/002
- Keywords
- HIV, COVID-19, Sars-Cov2, children, adolescents, paediatric, cohort, infectious diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 906 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre, University of Athens, University of Cape Town, Hospital General Universitario Gregorio Marañon, Hospital Sant Joan de Deu, Great Ormond Street Hospital for Children NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Northern Care Alliance NHS Group, University Hospital Birmingham NHS Foundation Trust, Imperial College Healthcare NHS Trust, King's College Hospital NHS Trust, St George's University Hospitals NHS Foundation Trust, CHIPS+ Cohort, University College, London
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 9 Jul 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Posted 20 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and Paediatric Infections Cohort Collaboration (EPPICC) Paediatric Study and the Cape Town Adolescent Antiretroviral Cohort (CTAAC). In CTAAC, adolescents without HIV are also enrolled and will be included in this study. For all participants, two blood samples will be taken at routine clinic visits approximately six months apart and tested for antibodies to SARS-CoV-2; clinical data and data on potential COVID-19 exposures will also be collected.
MAIN AIM OF THE STUDY The overall aim of this study is to describe the prevalence and distribution of antibodies to SARS-CoV-2 in children and adolescents living with HIV in Europe and South Africa.
Primary objective:
•To estimate prevalence of SARS-CoV-2 antibodies in the paediatric and adolescent HIV population and how this changes over time, overall and by key age groups and regions
Secondary objectives:
- To assess factors associated with presence of SARS-CoV-2 antibodies (including demographic factors, antiretroviral treatment, HIV-associated factors or co-morbidities and exposure to household members with COVID-19)
- To estimate the incidence of changes in antibody status to SARS-CoV-2 and associated factors
ENROLMENT Where feasible, all children and adolescents meeting the inclusion criteria and attending the participating clinics during the study period will be invited to take part; where this is not possible, a convenience sample of children and adolescents (e.g. those attending clinic on a specified day of the week) should be invited. The invitation to participate should be independent of the patient's probability of having been exposed to COVID-19. Participants enrolled in the EPPICC Paediatric Study or CTAAC will continue to be followed up as part of the ongoing study.
DATA COLLECTION The study will use data collected in the main EPPICC Paediatric study for participants attending clinics which participate in that study. This includes demographic data and clinical, therapeutic, laboratory and outcome information relating to HIV, COVID-19 and multi-system inflammatory syndrome in children (MIS-C). These data are extracted from clinic records and submitted as part of the main EPPICC study, and will be linked to data collected through the serology study.
Sites which are not members of the EPPICC network will submit equivalent data relating to the time of the two study visits for CLWHIV and HIV-uninfected adolescents.
Additionally, a short questionnaire will be completed by the participant (or their parent / carer) about potential exposures to COVID-19, including diagnoses in household members and known contacts.
For any participant with a record of a suspected or confirmed COVID-19 or MIS-C diagnosis, the cohort will be asked to complete an additional case record form providing details of the diagnosis (e.g. clinical features, hospital admissions, treatments and outcomes).
Cohorts will send pseudonymised electronic datasets to the MRC CTU at UCL. Transfer of data to the MRC CTU at UCL takes place using Galaxkey or an equivalent secure method such as UCL's REDCap server. Data will then be uploaded into a customised database.
LABORATORY TESTING Where sites are conducting serological testing as part of standard care, venous blood samples taken at each site will be transported to the laboratory(ies) routinely carrying out antibody testing for that site. Samples will be analysed with the tests used by each site in routine practice according to manufacturers' instructions or, if in-house tests are used, local SOPs/protocols.
At sites not offering routine serological testing, arrangements should be made with local laboratories for testing. There is strong preference for tests for IgG against the viral spike protein; however, it is recognised that there may be local considerations influencing the range of tests available across settings and results from other tests will be considered.
DISCONTINUATION OR EARLY WITHDRAWAL OF PARTICIPANTS Participants (or their parents/carers) may withdraw from the study at any time without providing a reason.
Participants wishing to withdraw from the study will be offered two options:
- Participants may withdraw from active follow-up (i.e. future study procedures) within this study but allow the retention and use of data already collected, and further linkage with other data sources as described in the Participant Information Sheet.
- Participants may withdraw completely from the study, in which case all data and samples collected (if not already tested) would be destroyed and no further follow-up or linkage would take place as part of this study.
Should a participant (or their parent / carer) lose the capacity to consent, they will be withdrawn from active follow-up and their data / samples retained and included in data linkages. Participants who withdraw for any reason will not be replaced.
All withdrawals will be recorded in the study database.
ANALYSIS PLAN Proportions with SARS-CoV-2 antibody at baseline and follow-up and the number/incidence of changes in antibody status between baseline and subsequent test will be estimated overall and by key patient characteristics, region, history of symptomatic COVID-19, contact with COVID-19 cases. Factors associated with the presence of SARS-CoV-2 antibody, changes in antibody status and any subsequent COVID-19 diagnosis (if numbers allow), will be explored using univariable and multivariable logistic and Poisson regression. Exposures of interest include age, sex, ART class and regimen (e.g. protease inhibitor- or tenofovir-based versus other), CD4 count, viral load, ethnicity, BMI-for-age z-score, co-infections (e.g. tuberculosis), co-morbidities and household size.
The association between HIV status and SARS-CoV-2 seropositivity, changes in antibody status and subsequent COVID-19 diagnosis will be assessed in the South African cohort (which includes HIV-uninfected children as well as CLWHIV) using similar methods.
If there is substantial variation in the type of antibody test used (anti-S versus anti-N), analyses will be stratified by type of test. For participants with positive results at both baseline and follow-up and if data allow, quantitative antibody results will be explored to qualitatively describe the possible contribution of re-exposure boosting antibody responses (versus persistence of an existing response).
In sensitivity analyses, we will investigate the implications of misclassification of results due to imperfect sensitivity / specificity of the serological tests used.
COMPLIANCE The study will be conducted in compliance with the approved protocol, the Declaration of Helsinki 1996, the principles of Good Clinical Practice as laid down by the ICH topic E6 (R2), General Data Protection Regulation and the UK Data Protection Act 2018 (DPA number: Z6364106), and the UK Policy Framework for Health and Social Care Research.
Each cohort is responsible for ensuring compliance with local and national regulatory and ethical processes, and data protection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Paediatric infectious disease clinics across Europe and ongoing study in South Africa
Key inclusion criteria (11 listed)
- < 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With at Least One Positive SARS-CoV-2 Antibody Test.
Time frame: 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.
Time frame: Throughout follow-up (at baseline for participants with one sample only; median 6 months for those with two samples)
Participants who have not received the SARS-CoV-2 vaccine at the time the sample was taken.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Intira J Collins, PhD study director
jeannie.collins@ucl.ac.uk
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-Cov2 Antibodies in Children and Adolescents Living With HIV, run by PENTA Foundation at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Belgium, Greece, South Africa, Ukraine and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With at Least One Positive SARS-CoV-2 Antibody Test. (time frame: Throughout follow-up (at baseline for participants with one sample only; median 6 months for those with two samples)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.