COVID-19Covid_IMMUNONCT05795790
Serology and Other Immunologic Response Tests in the Diagnosis of COVID-19 in Pediatrics
An observational study of COVID-19, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Despite the SARS-CoV-2 virus being present worldwide, and although it is now clear that children are affected by the disease with milder symptoms than adults, many immunological questions, which are very relevant for Public Health reasons and for the organization of services, remain unsolved. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- COVID-19
- How many people
- 249 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jan 2021to 31 Dec 2023
- 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 Up to 17 years
- All sexes
- Child
Study population: Pediatric subjects (0-17 years) accessing National Health System facilities for blood collection
Who may be able to join
- Children aged 0-17 years
- Access to National Health System facilities for blood collection.
Who cannot join
- Immunodepression (primary or secondary)
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, 34137
Marzia Lazzerini, MD, +390403785555, marzia.lazzerini@burlo.trieste.it
About this study
Official title: Observational Cross-sectional Study to Define the Role of Serology and Other Immunological Tests in the Diagnosis of COVID-19 in the Pediatric Population
Despite the SARS-CoV-2 virus being present worldwide, and although it is now clear that children are affected by the disease with milder symptoms than adults, many immunological questions, which are very relevant for Public Health reasons and for the organization of services, remain unsolved. The role of serology for the diagnosis of COVID-19, particularly in the pediatric age, is still very uncertain. Preliminary evidence suggests that not all children with SARS-Cov-2 infection develop antibody levels that can be detected by currently employed methods. This makes it crucial to identify other methodologies that are able to evaluate the true prevalence of prior SARS-CoV-2 infection in the pediatric population. Many other aspects of the immunological mechanisms of response to SARS-CoV-2 are also uncertain, such as the role of cellular immunity, and generally the role of immunity (cellular and antibody) in protecting against the disease in the medium and long term. Finally, questions remain open regarding cross-immunity with other previously circulating coronaviruses and their impact on the pediatric population in terms of protection against COVID-19 infection, disease development, or reinfection. This study aims to help clarify the role of serology and other immune response tests in the diagnosis of COVID-19 in the pediatric population. Specifically, it aims to assess: the prevalence of SARS-CoV-2 seroconversion cases among the pediatric population accessing the National Health System (NHS), at different moments in time and in different regions of Italy; whether cellular immunity tests can help to identify children who have had SARS-CoV-2 infection, particularly children with low antibody levels, and thus to better estimate the prevalence of prior SARS-CoV-2 infection; the prevalence of cross-reactivity with other coronaviruses; whether immunity (antibody and cellular) is protective in the medium/long term; and if there are healthy carriers, i.e. individuals who have had prior SARS-CoV-2 infection, who are asymptomatic but may harbor SARS-CoV-2 in the pharynx, with the risk of transmitting it.
- Conditions
- COVID-19
- Keywords
- COVID-19, Pediatrics, Immunology
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SARS-CoV-2 seroconversion
In blood samples collected among the pediatric population accessing the National Health System at different times and in different regions of Italy
Measured: Through study completion, an average of 3 years
Secondary outcomes (4)
Prevalence of subjects with a cellular T response to SARS-CoV-2
In blood samples collected among the pediatric population accessing the National Health System at different times and in different regions of Italy
Measured: Through study completion, an average of 3 years
Prevalence of cross-reactivity with other coronaviruses
In blood samples collected among the pediatric population accessing the National Health System at different times and in different regions of Italy
Measured: Through study completion, an average of 3 years
Frequency of activation of IgG-type immunity (antibody and cellular) in children testing positive for SARS-CoV-2 at nasopharyngeal swab
In blood samples collected among the pediatric population accessing the National Health System at different times and in different regions of Italy
Measured: Through study completion, an average of 3 years
Persistence of positivity for SARS-CoV-2 at nasopharyngeal swab
Among the pediatric population accessing the National Health System at different times and in different regions of Italy
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start4 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marzia Lazzerini, MD, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795790
- Sponsor's protocol ID
- RC 35/20
- Acronym
- Covid_IMMUNO
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cross-sectional Study to Define the Role of Serology and Other Immunological Tests in the Diagnosis of COVID-19 in the Pediatric Population
- ClinicalTrials.gov ID
- NCT05795790
- Acronym / sponsor ID
- Covid_IMMUNO / RC 35/20
- Conditions
- COVID-19
- Keywords
- COVID-19, Pediatrics, Immunology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Apr 2023 (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.
Despite the SARS-CoV-2 virus being present worldwide, and although it is now clear that children are affected by the disease with milder symptoms than adults, many immunological questions, which are very relevant for Public Health reasons and for the organization of services, remain unsolved. The role of serology for the diagnosis of COVID-19, particularly in the pediatric age, is still very uncertain. Preliminary evidence suggests that not all children with SARS-Cov-2 infection develop antibody levels that can be detected by currently employed methods. This makes it crucial to identify other methodologies that are able to evaluate the true prevalence of prior SARS-CoV-2 infection in the pediatric population. Many other aspects of the immunological mechanisms of response to SARS-CoV-2 are also uncertain, such as the role of cellular immunity, and generally the role of immunity (cellular and antibody) in protecting against the disease in the medium and long term. Finally, questions remain open regarding cross-immunity with other previously circulating coronaviruses and their impact on the pediatric population in terms of protection against COVID-19 infection, disease development, or reinfection. This study aims to help clarify the role of serology and other immune response tests in the diagnosis of COVID-19 in the pediatric population. Specifically, it aims to assess: the prevalence of SARS-CoV-2 seroconversion cases among the pediatric population accessing the National Health System (NHS), at different moments in time and in different regions of Italy; whether cellular immunity tests can help to identify children who have had SARS-CoV-2 infection, particularly children with low antibody levels, and thus to better estimate the prevalence of prior SARS-CoV-2 infection; the prevalence of cross-reactivity with other coronaviruses; whether immunity (antibody and cellular) is protective in the medium/long term; and if there are healthy carriers, i.e. individuals who have had prior SARS-CoV-2 infection, who are asymptomatic but may harbor SARS-CoV-2 in the pharynx, with the risk of transmitting it.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric subjects (0-17 years) accessing National Health System facilities for blood collection
Key inclusion criteria (2 listed)
- Children aged 0-17 years
- Access to National Health System facilities for blood collection.
Key exclusion criteria (2 listed)
- Immunodepression (primary or secondary)
- Refusal to participate in the study
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
Prevalence of SARS-CoV-2 seroconversion
Time frame: Through study completion, an average of 3 years
In blood samples collected among the pediatric population accessing the National Health System at different times and in different regions of Italy
4 secondary outcomes
Prevalence of subjects with a cellular T response to SARS-CoV-2
Time frame: Through study completion, an average of 3 years
Prevalence of cross-reactivity with other coronaviruses
Time frame: Through study completion, an average of 3 years
Frequency of activation of IgG-type immunity (antibody and cellular) in children testing positive for SARS-CoV-2 at nasopharyngeal swab
Time frame: Through study completion, an average of 3 years
Persistence of positivity for SARS-CoV-2 at nasopharyngeal swab
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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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.
Marzia Lazzerini, MD study director
IRCCS materno infantile Burlo Garofolo
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 IRCCS Burlo Garofolo at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marzia Lazzerini, MD (+390403785555, marzia.lazzerini@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SARS-CoV-2 seroconversion (time frame: Through study completion, an average of 3 years). 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 3 Apr 2023.