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The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study
BACKGROUND: Data regarding the kinetics of anti–SARS-CoV-2 antibodies and information about post–COVID-19 condition (colloquially known as “long COVID”) in children are scarce, especially in low-income countries. Even though cases of COVID-19 in children are less prevalent than adults, post–COVID-19...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10246664/ https://www.ncbi.nlm.nih.gov/pubmed/37246961 http://dx.doi.org/10.2196/43344 |
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author | Arguni, Eggi Chamida, Fatia Murni Indrawanti, Ratni Rusmawatiningtyas, Desy Dewi, Yunika Puspa Laksanawati, Ida Safitri |
author_facet | Arguni, Eggi Chamida, Fatia Murni Indrawanti, Ratni Rusmawatiningtyas, Desy Dewi, Yunika Puspa Laksanawati, Ida Safitri |
author_sort | Arguni, Eggi |
collection | PubMed |
description | BACKGROUND: Data regarding the kinetics of anti–SARS-CoV-2 antibodies and information about post–COVID-19 condition (colloquially known as “long COVID”) in children are scarce, especially in low-income countries. Even though cases of COVID-19 in children are less prevalent than adults, post–COVID-19 condition cases in children are high and have a burden that may impact their growth and development. There are other features of antibody kinetics in connection with SARS-CoV-2 infection that are yet unknown as of this writing, especially in children following infection. Furthermore, the long-term results, risk factors, and underlying pathophysiology are still uncertain. To better understand post–COVID-19 condition in children, it is necessary to further investigate the impact of clinically significant factors such multisystem inflammatory syndrome and disease severity among hospitalized survivors through their SARS-CoV-2 antibody response. OBJECTIVE: We aim to analyze anti–receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies over time and characterize the signs and symptoms of post–COVID-19 condition in pediatric patients at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. METHODS: This is a longitudinal observational study in Indonesia. Pediatric patients diagnosed with COVID-19 by positive molecular assay using nasopharyngeal swab will be tested for anti–SARS-CoV-2 antibodies using the Roche Elecsys Anti-SARS-CoV-2 S assay at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. Antibody titer data will be reported as means and SDs. The respondents’ signs and symptoms will be observed up to 6 months after the onset of infection, including the vaccination event, reinfection, rehospitalization, and mortality. The clinical features will be reported as frequencies and percentages. RESULTS: Participant enrollment began in February 2022. As of September 30, 2022, a total of 58 patients were enrolled. After data collection, results are expected to be analyzed in August 2023. CONCLUSIONS: This study will allow us to know the kinetics of anti–receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies and data regarding post–COVID-19 condition up to 6 months following infection in the Indonesian pediatric population. Furthermore, this study has the potential to serve as a foundation for government decisions about vaccination programs and prevention measures. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43344 |
format | Online Article Text |
id | pubmed-10246664 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-102466642023-06-08 The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study Arguni, Eggi Chamida, Fatia Murni Indrawanti, Ratni Rusmawatiningtyas, Desy Dewi, Yunika Puspa Laksanawati, Ida Safitri JMIR Res Protoc Protocol BACKGROUND: Data regarding the kinetics of anti–SARS-CoV-2 antibodies and information about post–COVID-19 condition (colloquially known as “long COVID”) in children are scarce, especially in low-income countries. Even though cases of COVID-19 in children are less prevalent than adults, post–COVID-19 condition cases in children are high and have a burden that may impact their growth and development. There are other features of antibody kinetics in connection with SARS-CoV-2 infection that are yet unknown as of this writing, especially in children following infection. Furthermore, the long-term results, risk factors, and underlying pathophysiology are still uncertain. To better understand post–COVID-19 condition in children, it is necessary to further investigate the impact of clinically significant factors such multisystem inflammatory syndrome and disease severity among hospitalized survivors through their SARS-CoV-2 antibody response. OBJECTIVE: We aim to analyze anti–receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies over time and characterize the signs and symptoms of post–COVID-19 condition in pediatric patients at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. METHODS: This is a longitudinal observational study in Indonesia. Pediatric patients diagnosed with COVID-19 by positive molecular assay using nasopharyngeal swab will be tested for anti–SARS-CoV-2 antibodies using the Roche Elecsys Anti-SARS-CoV-2 S assay at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. Antibody titer data will be reported as means and SDs. The respondents’ signs and symptoms will be observed up to 6 months after the onset of infection, including the vaccination event, reinfection, rehospitalization, and mortality. The clinical features will be reported as frequencies and percentages. RESULTS: Participant enrollment began in February 2022. As of September 30, 2022, a total of 58 patients were enrolled. After data collection, results are expected to be analyzed in August 2023. CONCLUSIONS: This study will allow us to know the kinetics of anti–receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies and data regarding post–COVID-19 condition up to 6 months following infection in the Indonesian pediatric population. Furthermore, this study has the potential to serve as a foundation for government decisions about vaccination programs and prevention measures. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43344 JMIR Publications 2023-06-06 /pmc/articles/PMC10246664/ /pubmed/37246961 http://dx.doi.org/10.2196/43344 Text en ©Eggi Arguni, Fatia Murni Chamida, Ratni Indrawanti, Desy Rusmawatiningtyas, Yunika Puspa Dewi, Ida Safitri Laksanawati. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.06.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Arguni, Eggi Chamida, Fatia Murni Indrawanti, Ratni Rusmawatiningtyas, Desy Dewi, Yunika Puspa Laksanawati, Ida Safitri The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study |
title | The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study |
title_full | The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study |
title_fullStr | The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study |
title_full_unstemmed | The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study |
title_short | The Kinetics of Anti–SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post–COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study |
title_sort | kinetics of anti–sars-cov-2 antibodies in pediatric patients and the characterization of post–covid-19 condition at 6 months after infection: protocol for a longitudinal observational study |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10246664/ https://www.ncbi.nlm.nih.gov/pubmed/37246961 http://dx.doi.org/10.2196/43344 |
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