Serology and Other Immunologic Response Tests in the Diagnosis of COVID-19 in Pediatrics

COVID-19 Clinical Trial

— Covid_IMMUNO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795790
• Other study ID #: RC 35/20
• Status: Recruiting
• Start date: January 4, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: IRCCS Burlo Garofolo
• Contact: Marzia Lazzerini, MD
• Phone: +390403785555
• Email: marzia.lazzerini[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Children aged 0-17 years

• Access to National Health System facilities for blood collection.

Exclusion Criteria:

• Immunodepression (primary or secondary)

• Refusal to participate in the study

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 3 years
Secondary	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	Through study completion, an average of 3 years
Secondary	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	Through study completion, an average of 3 years
Secondary	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	Through study completion, an average of 3 years
Secondary	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	Through study completion, an average of 3 years