COVID-19NCT05358626
Seroprevalence of Infection-induced SARS-CoV-2 Antibodies (COVID-19) in Children
An observational study of COVID-19, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial summary
It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions. The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- COVID-19
- What is being tested?
- SARS-CoV-2 IgG Antibody testing
- How many people
- 4,032 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Mar 2022to 13 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: In-patient or out-patient children aged from 0 to 18 years old, who have not have not been previously diagnosed and are presumed/confirmed COVID-19 negative, have blood specimens collected for routine biochemistry tests.
Who may be able to join
- Age ≤ 18 years old.
- Seeking medical care at Vietnam National Children's Hospital for any condition not related to acute Covid-19
- Have not been previously diagnosed and are presumed/confirmed COVID-19 negative
- Have blood specimens collected for any routine biochemistry test on the date enrollment
Who cannot join
- Refusal to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam
It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions.
The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children
Read the detailed description
Enrolled participants will have a survey about demographic information, history of previous suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status. For participants aged less than 12 months, participants' mothers' status of Covid-19 vaccination and/or previous infection will be recorded. Participants will then complete serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 IgG Antibody testing
- Keywords
- SARS-CoV-2, Seroprevalence, IgG Antibodies, Children, Vietnam, Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 IgG Antibody testingDiagnostic test
IgG Antibody testing for previous exposure to SARS-CoV-2
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of children with IgG SARS-CoV-2 antibodies in Plasma
The percentage of children with IgG SARS-CoV-2 antibodies to the total number of children enrolled in the study
Measured: 6 month
Immunoglobulins (G) to SARS-CoV-2 in plasma
Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays
Measured: 6 month
Secondary outcomes (1)
Measure of association between SARS-CoV-2 IgG seropositivity and characteristics
socio-demographics, previous exposure to SARS-CoV-2
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start13 Mar 2022
- Primary completion5 Jun 2022
- Study completion13 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cross-sectional
- Enrolment
- 4,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phuc Huu Phan, National Children's Hospital, Vietnam
- Investigators
- Phuc H Phan, MD, Principal investigator, National Children's Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358626
- Sponsor's protocol ID
- ChildrensHVietnam
- Status last verified
- Mar 2023
- First submitted
- 30 Apr 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam
- ClinicalTrials.gov ID
- NCT05358626
- Acronym / sponsor ID
- ChildrensHVietnam
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Seroprevalence, IgG Antibodies, Children, Vietnam, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,032 participants (actual)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 13 Nov 2022 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions.
The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children
Detailed description
Enrolled participants will have a survey about demographic information, history of previous suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status. For participants aged less than 12 months, participants' mothers' status of Covid-19 vaccination and/or previous infection will be recorded. Participants will then complete serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- In-patient or out-patient children aged from 0 to 18 years old, who have not have not been previously diagnosed and are presumed/confirmed COVID-19 negative, have blood specimens collected for routine biochemistry tests.
Key inclusion criteria (4 listed)
- Age ≤ 18 years old.
- Seeking medical care at Vietnam National Children's Hospital for any condition not related to acute Covid-19
- Have not been previously diagnosed and are presumed/confirmed COVID-19 negative
- Have blood specimens collected for any routine biochemistry test on the date enrollment
Key exclusion criteria (1 listed)
- Refusal to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 IgG Antibody testingIgG Antibody testing for previous exposure to SARS-CoV-2 | Diagnostic test | – |
Primary outcome
The percentage of children with IgG SARS-CoV-2 antibodies in Plasma
Time frame: 6 month
The percentage of children with IgG SARS-CoV-2 antibodies to the total number of children enrolled in the study
Immunoglobulins (G) to SARS-CoV-2 in plasma
Time frame: 6 month
Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays
1 secondary outcome
Measure of association between SARS-CoV-2 IgG seropositivity and characteristics
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Phuc H Phan, MD principal investigator
National Children's Hospital, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
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 4 inclusion and 1 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage of children with IgG SARS-CoV-2 antibodies in Plasma (time frame: 6 month). 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 9 Mar 2023.