Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05795790

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

COVID-19 Clinical Trial

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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05795790
Study type Observational
Source IRCCS Burlo Garofolo
Contact Marzia Lazzerini, MD
Phone +390403785555
Email marzia.lazzerini@burlo.trieste.it
Status Recruiting
Phase
Start date January 4, 2021
Completion date December 31, 2023
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure