Trial Outcomes & Findings for European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol. Covid-19 (NCT NCT04726137)
NCT ID: NCT04726137
Last Updated: 2024-09-20
Results Overview
Recruitment status
COMPLETED
Target enrollment
906 participants
Primary outcome timeframe
Throughout follow-up (at baseline for participants with one sample only; median 6 months for those with two samples)
Results posted on
2024-09-20
Participant Flow
Participant milestones
| Measure |
Study Cohort.
This is an observational study in which consenting participants were enrolled from existing cohorts (EPPICC European Pregnancy and Paediatric Infections Cohort Collaboration, CTAAC Cape Town Adolescent Antiretroviral Cohort and CHIPS+ Collaborative HIV Paediatric Study+). EPPICC and CHIPS+ comprise children and adolescents living with HIV (CALWHIV); CTAAC also enrols HIV-negative adolescents. Participants were eligible if they were aged \<25 and, amongst CALWHIV, aged \<18 at the time of HIV diagnosis. Initially, SARS-CoV-2 vaccination was an exclusion criterion, although this was subsequently removed in anticipation of increasing vaccine availability. Following informed consent / assent, all participants gave up to two blood samples for serological analysis. (This may be considered as a 'single arm' study).
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|---|---|
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Overall Study
STARTED
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906
|
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Overall Study
COMPLETED
|
759
|
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Overall Study
NOT COMPLETED
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147
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant was missing age data
Baseline characteristics by cohort
| Measure |
Study Cohort.
n=903 Participants
This is an observational study in which consenting participants were enrolled from existing cohorts (EPPICC European Pregnancy and Paediatric Infections Cohort Collaboration, CTAAC Cape Town Adolescent Antiretroviral Cohort and CHIPS+ Collaborative HIV Paediatric Study+). EPPICC and CHIPS+ comprise children and adolescents living with HIV (CALWHIV); CTAAC also enrols HIV-negative adolescents. Participants were eligible if they were aged \<25 and, amongst CALWHIV, aged \<18 at the time of HIV diagnosis. Initially, SARS-CoV-2 vaccination was an exclusion criterion, although this was subsequently removed in anticipation of increasing vaccine availability. Following informed consent / assent, all participants gave up to two blood samples for serological analysis. (This may be considered as a 'single arm' study).
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|---|---|
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Age, Continuous
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17.1 years
n=902 Participants • One participant was missing age data
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Sex: Female, Male
Female
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476 Participants
n=903 Participants
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Sex: Female, Male
Male
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427 Participants
n=903 Participants
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Race/Ethnicity, Customized
White/Caucasian
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59 participants
n=903 Participants
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Race/Ethnicity, Customized
Black
|
612 participants
n=903 Participants
|
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Race/Ethnicity, Customized
Other
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64 participants
n=903 Participants
|
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Race/Ethnicity, Customized
Unknown
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168 participants
n=903 Participants
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Region of Enrollment
Greece
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21 participants
n=903 Participants
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Region of Enrollment
Belgium
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19 participants
n=903 Participants
|
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Region of Enrollment
Ukraine
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160 participants
n=903 Participants
|
|
Region of Enrollment
South Africa
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410 participants
n=903 Participants
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Region of Enrollment
United Kingdom
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202 participants
n=903 Participants
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Region of Enrollment
Spain
|
91 participants
n=903 Participants
|
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HIV infection
|
800 Participants
n=903 Participants
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PRIMARY outcome
Timeframe: Throughout follow-up (at baseline for participants with one sample only; median 6 months for those with two samples)Outcome measures
| Measure |
Study Cohort.
n=903 Participants
This is an observational study in which consenting participants were enrolled from existing cohorts (EPPICC European Pregnancy and Paediatric Infections Cohort Collaboration, CTAAC Cape Town Adolescent Antiretroviral Cohort and CHIPS+ Collaborative HIV Paediatric Study+). EPPICC and CHIPS+ comprise children and adolescents living with HIV (CALWHIV); CTAAC also enrols HIV-negative adolescents. Participants were eligible if they were aged \<25 and, amongst CALWHIV, aged \<18 at the time of HIV diagnosis. Initially, SARS-CoV-2 vaccination was an exclusion criterion, although this was subsequently removed in anticipation of increasing vaccine availability. Following informed consent / assent, all participants gave up to two blood samples for serological analysis. (This may be considered as a 'single arm' study).
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Number of Participants With at Least One Positive SARS-CoV-2 Antibody Test.
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563 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Study Cohort.
n=770 Participants
This is an observational study in which consenting participants were enrolled from existing cohorts (EPPICC European Pregnancy and Paediatric Infections Cohort Collaboration, CTAAC Cape Town Adolescent Antiretroviral Cohort and CHIPS+ Collaborative HIV Paediatric Study+). EPPICC and CHIPS+ comprise children and adolescents living with HIV (CALWHIV); CTAAC also enrols HIV-negative adolescents. Participants were eligible if they were aged \<25 and, amongst CALWHIV, aged \<18 at the time of HIV diagnosis. Initially, SARS-CoV-2 vaccination was an exclusion criterion, although this was subsequently removed in anticipation of increasing vaccine availability. Following informed consent / assent, all participants gave up to two blood samples for serological analysis. (This may be considered as a 'single arm' study).
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|---|---|
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Number of Unvaccinated Participants With at Least One Positive SARS-CoV-2 Antibody Test.
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409 participants
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Adverse Events
Study Cohort.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place