NCT05898529

Brief Summary

Children infected with COVID-19 are mostly asymptomatic. There is a dearth of data on the epidemiology of COVID-19 in the pediatric population. This is a prospective observational clinical study of pediatric surgical patients. COVID-19 rapid antigen testing will be performed on pediatric patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

June 9, 2023

Last Update Submit

January 23, 2025

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Antigen test positive result

    COVID-19 antigen test positive

    1 day

Interventions

Rapid antigen testDIAGNOSTIC_TEST

COVID-19 rapid antigen testing of nasal swab

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Consecutive surgical patients, aged 2-17 years.

You may qualify if:

  • surgical patients aged 2-17 years
  • informed consent for surgery
  • no COVID-19 diagnosis in previous 6 months
  • no history of nasal bleeding
  • no history of coagulopathy.

You may not qualify if:

  • patient refusal of testing
  • difficulty in obtaining consent
  • COVID-19 diagnosis in recent 6 month
  • history of nasal bleeding
  • history of coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Olumuyiwa Bamgbade

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olumuyiwa Bamgbade, MD,FRCPC

CONTACT

17786286600olu.bamgbade@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 12, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)