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OpenTrials
Completed

NCT Number: NCT05358626

Seroprevalence of Infection-induced SARS-CoV-2 Antibodies (COVID-19) in Children

It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions.

The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vietnam National Children's Hospital

Hanoi, Vietnam

About this study

Enrolled participants will have a survey about demographic information, history of previous suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status. For participants aged less than 12 months, participants' mothers' status of Covid-19 vaccination and/or previous infection will be recorded. Participants will then complete serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≤ 18 years old.
  • Seeking medical care at Vietnam National Children's Hospital for any condition not related to acute Covid-19
  • Have not been previously diagnosed and are presumed/confirmed COVID-19 negative
  • Have blood specimens collected for any routine biochemistry test on the date enrollment

Exclusion criteria

  • Refusal to participate in this study.

Treatment and study plan

SARS-CoV-2 IgG Antibody testing

Diagnostic Test

IgG Antibody testing for previous exposure to SARS-CoV-2

Primary outcomes

  1. The percentage of children with IgG SARS-CoV-2 antibodies in Plasma

    Time frame: 6 month

    The percentage of children with IgG SARS-CoV-2 antibodies to the total number of children enrolled in the study

  2. Immunoglobulins (G) to SARS-CoV-2 in plasma

    Time frame: 6 month

    Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays

Secondary outcomes

  1. Measure of association between SARS-CoV-2 IgG seropositivity and characteristics

    Time frame: 6 month

    socio-demographics, previous exposure to SARS-CoV-2

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Registry information

Official study title

Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 3, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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