Borderline COVID-19 PCR Test Result

February 15, 2021 updated by: Jessa Hospital

Follow-up of Patients With a Borderline COVID-19 PCR Test Result

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Clinical Laboratory Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Ambulant (majority)
  • Hospital personnel
  • Hospitalized patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result.
Diagnostic test: SARS-CoV-2 PCR
SARS-CoV-2 PCR of nasopharyngeal lysate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio of positivity conversion after receiving a COVID-19 borderline PCR result.
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms predicting COVID-19 positivity conversion after receiving a borderline PCR result.
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • f/2020/166

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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