SARS-CoV2 InfectionCoPSSNCT05128435
Coronavirus Pediatric Serological Study
An observational study of SARS-CoV2 Infection, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The Coronavirus Pediatric Serological Study's aim is to provide a better insight of children's immune response after SARS-CoV-2 infection. Serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection. Read more about this study
- Who is it for?
- Ages 0 to 179 monthsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Blood sample
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2020to 31 May 2021
- 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 179 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children under 15 years old
Who may be able to join
- Tested positive for SARS-CoV-2 by PCR on naso-pharyngeal swab performed in Saint-Pierre Hospital (Brussels) between March 1 2020 and December 31 2020
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
The Coronavirus Pediatric Serological Study's aim is to provide a better insight of children's immune response after SARS-CoV-2 infection.
Serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection.
The study was performed in collaboration with the Institute of Medical Immunology, were antibody levels were measured and immunoglobulin subclasses profiles were studied.
Read the detailed description
The hospital laboratory provided us the list of children under 15 years old tested for SARS-CoV-2 in Saint-Pierre Hospital (Brussels) by PCR on nasopharyngeal swab between March 1 2020 and December 31 2020.
The medical files of all children that were tested positive for SARS-CoV-2 were reviewed and clinical information was collected.
For each positive child, the family was contacted by phone 3 months after the proven viral infection in order to ask permission to take a single blood test.
Covid19 serologies were performed in the hospital laboratory, and blood samples were then sent to the Institute of Medical Immunology, were antibody levels and immunoglobulin subclasses were studied.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Blood sample
- Keywords
- SARS-CoV-2, Immune response, Children
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Blood sample taken 3 to 5 months after the infection
| Study group | Role | What they receive |
|---|---|---|
| Positive Children | Children under 15 years old tested positive for SARS-CoV-2 by PCR on nasopharyngeal swab Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 antibody levels in asymptomatic patients
Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who did not show any symptoms at the time of the viral infection
Measured: 3 to 5 months after SARS-CoV-2 infection
SARS-CoV-2 antibody levels in mildly symptomatic patients
Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children presenting mild symptoms at the time of the viral infection
Measured: 3 to 5 months after SARS-CoV-2 infection
SARS-CoV-2 antibody levels in hospitalized patients
Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who required an hospitalisation at the time of the viral infection
Measured: 3 to 5 months after SARS-CoV-2 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Tomasi, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128435
- Sponsor's protocol ID
- 200629
- Acronym
- CoPSS
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 22 Nov 2021
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronavirus Pediatric Serological Study
- ClinicalTrials.gov ID
- NCT05128435
- Acronym / sponsor ID
- CoPSS / 200629
- Conditions
- SARS-CoV2 Infection
- Keywords
- SARS-CoV-2, Immune response, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 22 Nov 2021 (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.
The Coronavirus Pediatric Serological Study's aim is to provide a better insight of children's immune response after SARS-CoV-2 infection.
Serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection.
The study was performed in collaboration with the Institute of Medical Immunology, were antibody levels were measured and immunoglobulin subclasses profiles were studied.
Detailed description
The hospital laboratory provided us the list of children under 15 years old tested for SARS-CoV-2 in Saint-Pierre Hospital (Brussels) by PCR on nasopharyngeal swab between March 1 2020 and December 31 2020.
The medical files of all children that were tested positive for SARS-CoV-2 were reviewed and clinical information was collected.
For each positive child, the family was contacted by phone 3 months after the proven viral infection in order to ask permission to take a single blood test.
Covid19 serologies were performed in the hospital laboratory, and blood samples were then sent to the Institute of Medical Immunology, were antibody levels and immunoglobulin subclasses were studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive Children | – | Diagnostic Test: Blood sampleChildren under 15 years old tested positive for SARS-CoV-2 by PCR on nasopharyngeal swab |
Who may qualify
- Ages
- 0 to 179 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children under 15 years old
Key inclusion criteria (1 listed)
- Tested positive for SARS-CoV-2 by PCR on naso-pharyngeal swab performed in Saint-Pierre Hospital (Brussels) between March 1 2020 and December 31 2020
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| Blood sampleBlood sample taken 3 to 5 months after the infection | Diagnostic test | Positive Children |
Primary outcome
SARS-CoV-2 antibody levels in asymptomatic patients
Time frame: 3 to 5 months after SARS-CoV-2 infection
Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who did not show any symptoms at the time of the viral infection
SARS-CoV-2 antibody levels in mildly symptomatic patients
Time frame: 3 to 5 months after SARS-CoV-2 infection
Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children presenting mild symptoms at the time of the viral infection
SARS-CoV-2 antibody levels in hospitalized patients
Time frame: 3 to 5 months after SARS-CoV-2 infection
Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who required an hospitalisation at the time of the viral infection
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 22 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV2 Infection, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 1 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 22 Nov 2021. 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 Belgium. 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?
SARS-CoV-2 antibody levels in asymptomatic patients (time frame: 3 to 5 months after SARS-CoV-2 infection). The study lists 3 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 22 Nov 2021.