COVIDNCT04347408
Seroprevalence of SARS-Cov-2 Antibodies in Children
An observational study of COVID and Corona Virus Infection, run by Queen's University, Belfast at 5 sites in United Kingdom.
Trial summary
It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 1 month to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID, Corona Virus Infection, Multisystem Inflammatory Syndrome in Children
- What is being tested?
- Covid-19 Antibody testing (IgG and IgM) and Blood Storage
- How many people
- 1,100 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 6 May 2020to 14 Nov 2023
- 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 1 month to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged from 0 to 15 who are resident in the United Kingdom
Who may be able to join
None listed.
Who cannot join
- Not currently receiving antibiotics, not admitted to hospital within the last seven days, not receiving immunosuppressive drugs and never diagnosed with a malignancy.
- Admitted children with paediatric multisystem inflammatory syndrome and admitted children with other serious infections.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Royal Belfast Hospital for Sick Children
Belfast, BT126BA
University Hospital of Wales
Cardiff
Royal Hospital for Children
Glasgow
Public Health England
London
Public Health England
Manchester
About this study
Official title: Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study
It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.
Read the detailed description
Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome. The majority of coronaviruses cause disease in a specific host species but some have infected humans by cross-species transmission. This process has led to a number of severe outbreaks of human disease including severe acute respiratory syndrome (SARS) in 2003 and Middle East respiratory syndrome (MERS) in 2012.
From December 2019 a novel infection "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) was identified in the Wuhan region of China. The infection was identified as the causal factor in a growing number of severe cases of pneumonia. This disease was subsequently named coronavirus disease 2019 (COVID-19) by World Health Organisation (WHO). SARS-CoV-2 has been shown to cause severe disease similar to the previous SARS coronavirus from 2003. Severe disease is associated with pneumonia and damage to vital organs including lung, heart, liver, and kidney.
Fortunately SARS-CoV-2 appears to cause only mild, or no, symptoms in children.
The social distancing measures in the United Kingdom include the closure of schools and the cancelling of routine paediatric clinics. These drastic, but necessary, steps are likely to have a profound effect on the well-being of children.
This study is required to determine what proportion of children have been exposed to SARS-Cov-2 and how many, if any, have neutralizing antibodies. The findings from this study could be used to inform public health decisions regarding the re-opening of schools and other services vital to the well-being of children.
In addition the study will recruit children with paediatric multi-system inflammatory syndrome admitted to the Royal Belfast Hospital for Sick Children along with matched controls with other infections.
- Being tested
- Covid-19 Antibody testing (IgG and IgM), Blood Storage
- Keywords
- antibodies
- Medical subject headings
- Coronavirus Infections, pediatric multisystem inflammatory disease, COVID-19 related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 Antibody testing (IgG and IgM)Diagnostic test
Antibody testing for previous exposure to Covid-19
Blood StorageOther
Storage of blood for multi-omics analysis
| Study group | Role | What they receive |
|---|---|---|
| Healthy Children | Healthy children of healthcare workers between 2 and 15 years of age Receives: Diagnostic Test: Covid-19 Antibody testing (IgG and IgM); Other: Blood Storage | |
| Paediatric Multisystem Inflammatory Syndrome | Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome Receives: Diagnostic Test: Covid-19 Antibody testing (IgG and IgM); Other: Blood Storage | |
| Serious Infection | Children admitted to hospital with serious infections Receives: Diagnostic Test: Covid-19 Antibody testing (IgG and IgM); Other: Blood Storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoglobulins (G and M) to SARS-Cov2 in Plasma
- Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays
Measured: 6 months
Secondary outcomes (3)
Echocardiogram Ejection Fraction
Measure of cardiac function
Measured: 6 months
High-sensitivity Cardiac Troponin Test
Cardiac Enzyme
Measured: 6 months
Brain Natriuretic Peptide
Cardiac enzyme
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start6 May 2020
- Primary completion1 Dec 2021
- Study completion14 Nov 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Principal investigator, Thomas Waterfield, Queen's University, Belfast
- Investigators
- Thomas Waterfield, BMBCh, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347408
- Sponsor's protocol ID
- 282617
- Status last verified
- Nov 2023
- First submitted
- 7 Apr 2020
- Last updated
- 7 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Waterfield T, Watson C, Moore R, Ferris K, Tonry C, Watt A, McGinn C, Foster S, Evans J, Lyttle MD, Ahmad S, Ladhani S, Corr M, McFetridge L, Mitchell H, Brown K, Amirthalingam G, Maney JA, Christie S. Seroprevalence of SARS-CoV-2 antibodies in children: a prospective multicentre cohort study. Arch Dis Child. 2021 Jul;106(7):680-686. doi: 10.1136/archdischild-2020-320558. Epub 2020 Nov 10.
PubMed 33172887
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT04347408
- Acronym / sponsor ID
- 282617
- Keywords
- antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- 6 May 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Posted 18 Aug 2021
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 healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.
Detailed description
Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome. The majority of coronaviruses cause disease in a specific host species but some have infected humans by cross-species transmission. This process has led to a number of severe outbreaks of human disease including severe acute respiratory syndrome (SARS) in 2003 and Middle East respiratory syndrome (MERS) in 2012.
From December 2019 a novel infection "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) was identified in the Wuhan region of China. The infection was identified as the causal factor in a growing number of severe cases of pneumonia. This disease was subsequently named coronavirus disease 2019 (COVID-19) by World Health Organisation (WHO). SARS-CoV-2 has been shown to cause severe disease similar to the previous SARS coronavirus from 2003. Severe disease is associated with pneumonia and damage to vital organs including lung, heart, liver, and kidney.
Fortunately SARS-CoV-2 appears to cause only mild, or no, symptoms in children.
The social distancing measures in the United Kingdom include the closure of schools and the cancelling of routine paediatric clinics. These drastic, but necessary, steps are likely to have a profound effect on the well-being of children.
This study is required to determine what proportion of children have been exposed to SARS-Cov-2 and how many, if any, have neutralizing antibodies. The findings from this study could be used to inform public health decisions regarding the re-opening of schools and other services vital to the well-being of children.
In addition the study will recruit children with paediatric multi-system inflammatory syndrome admitted to the Royal Belfast Hospital for Sick Children along with matched controls with other infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Children | – | Diagnostic Test: Covid-19 Antibody testing (IgG and IgM), Other: Blood StorageHealthy children of healthcare workers between 2 and 15 years of age |
| Paediatric Multisystem Inflammatory Syndrome | – | Diagnostic Test: Covid-19 Antibody testing (IgG and IgM), Other: Blood StorageChildren admitted to hospital with Paediatric Multisystem Inflammatory Syndrome |
| Serious Infection | – | Diagnostic Test: Covid-19 Antibody testing (IgG and IgM), Other: Blood StorageChildren admitted to hospital with serious infections |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged from 0 to 15 who are resident in the United Kingdom
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Not currently receiving antibiotics, not admitted to hospital within the last seven days, not receiving immunosuppressive drugs and never diagnosed with a malignancy.
- Admitted children with paediatric multisystem inflammatory syndrome and admitted children with other serious infections.
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 |
|---|---|---|
| Covid-19 Antibody testing (IgG and IgM)Antibody testing for previous exposure to Covid-19 | Diagnostic test | Healthy Children, Paediatric Multisystem Inflammatory Syndrome, Serious Infection |
| Blood StorageStorage of blood for multi-omics analysis | Other | Healthy Children, Paediatric Multisystem Inflammatory Syndrome, Serious Infection |
Primary outcome
Immunoglobulins (G and M) to SARS-Cov2 in Plasma
Time frame: 6 months
• Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays
3 secondary outcomes
Echocardiogram Ejection Fraction
Time frame: 6 months
High-sensitivity Cardiac Troponin Test
Time frame: 6 months
Brain Natriuretic Peptide
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33172887Waterfield T, Watson C, Moore R, Ferris K, Tonry C, Watt A, McGinn C, Foster S, Evans J, Lyttle MD, Ahmad S, Ladhani S, Corr M, McFetridge L, Mitchell H, Brown K, Amirthalingam G, Maney JA, Christie S. Seroprevalence of SARS-CoV-2 antibodies in children: a prospective multicentre cohort study. Arch Dis Child. 2021 Jul;106(7):680-686. doi: 10.1136/archdischild-2020-320558. Epub 2020 Nov 10.
Related trials for COVID
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Thomas Waterfield, BMBCh principal investigator
Queen's University, Belfast
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Corona Virus Infection, run by Queen's University, Belfast at 5 sites in United Kingdom.
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 0 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 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 18 Aug 2021). 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?
Immunoglobulins (G and M) to SARS-Cov2 in Plasma (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347408, which also lists 1 linked publication.
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 7 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.