NCT04636294

Brief Summary

Follow-up of patients with a borderline PCR result. Data of patients that were re-tested within 96 hours after receiving a borderline COVID-19 PCR result are reviewed. This is a retrospective study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

November 18, 2020

Last Update Submit

February 15, 2021

Conditions

Covid19Virus

Outcome Measures

Primary Outcomes (1)

  • Ratio of positivity conversion after receiving a COVID-19 borderline PCR result.

    3 days

Secondary Outcomes (1)

  • Symptoms predicting COVID-19 positivity conversion after receiving a borderline PCR result.

    1 day

Study Arms (1)

COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result.

Diagnostic Test: SARS-CoV-2 PCR

Interventions

SARS-CoV-2 PCRDIAGNOSTIC_TEST

SARS-CoV-2 PCR of nasopharyngeal lysate.

COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Ambulant (majority) * Hospital personnel * Hospitalized patients

You may qualify if:

  • Every individual that delivers a nasopharyngeal lysate for SARS-CoV-2 RNA determination by PCR.

You may not qualify if:

  • Patients without a previous borderline COVID-19 PCR result within 96 hours are excluded for the follow-up study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Laboratory Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (1)

  • Boeckmans J, Cartuyvels R, Hilkens P, Bruckers L, Magerman K, Waumans L, Raymaekers M. Follow-up testing of borderline SARS-CoV-2 patients by rRT-PCR allows early diagnosis of COVID-19. Diagn Microbiol Infect Dis. 2021 Jun;100(2):115350. doi: 10.1016/j.diagmicrobio.2021.115350. Epub 2021 Feb 18.

    PMID: 33689985DERIVED

MeSH Terms

Conditions

COVID-19Virus Diseases

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 19, 2020

Study Start

August 1, 2020

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

BE(1)