NCT05358626

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,032

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2022

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

April 30, 2022

Last Update Submit

March 8, 2023

Conditions

Keywords

SARS-CoV-2SeroprevalenceIgG AntibodiesChildrenVietnamCovid-19

Outcome Measures

Primary Outcomes (2)

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

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

    6 month

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

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

    6 month

Secondary Outcomes (1)

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

    6 month

Interventions

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

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

In-patient or out-patient children aged from 0 to 18 years old, who have not have not been previously diagnosed and are presumed/confirmed COVID-19 negative, have blood specimens collected for routine biochemistry tests.

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnam National Children's Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Phuc H Phan, MD

    Vietnam National Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 3, 2022

Study Start

March 13, 2022

Primary Completion

June 5, 2022

Study Completion

November 13, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations