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

NCT05795790 | Unknown

• 1 other identifier: RC 35/20
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; Pediatrics; Immunology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Prevalence of subjects with a cellular T response to SARS-CoV-2

  Through study completion, an average of 3 years

• Prevalence of cross-reactivity with other coronaviruses

  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

  Through study completion, an average of 3 years

• Persistence of positivity for SARS-CoV-2 at nasopharyngeal swab

  Through study completion, an average of 3 years

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric subjects (0-17 years) accessing National Health System facilities for blood collection

You may qualify if:

• Children aged 0-17 years
• Access to National Health System facilities for blood collection.

You may not qualify if:

• Immunodepression (primary or secondary)
• Refusal to participate in the study

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marzia Lazzerini, MD

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Central Study Contacts

Marzia Lazzerini, MD

CONTACT

+390403785555; marzia.lazzerini@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 3, 2023
• Study Start: January 4, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

IT (1)