Covid19NCT04636294
Borderline COVID-19 PCR Test Result
An observational study of Covid19 and Virus, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- SARS-CoV-2 PCR
- How many people
- 30,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2020to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: * Ambulant (majority) * Hospital personnel * Hospitalized patients
Who may be able to join
- Every individual that delivers a nasopharyngeal lysate for SARS-CoV-2 RNA determination by PCR.
Who cannot join
- Patients without a previous borderline COVID-19 PCR result within 96 hours are excluded for the follow-up study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- SARS-CoV-2 PCR
- Medical subject headings
- COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 PCRDiagnostic test
SARS-CoV-2 PCR of nasopharyngeal lysate.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result. | Not described Receives: Diagnostic Test: SARS-CoV-2 PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of positivity conversion after receiving a COVID-19 borderline PCR result.
Measured: 3 days
Secondary outcomes (1)
Symptoms predicting COVID-19 positivity conversion after receiving a borderline PCR result.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Aug 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636294
- Sponsor's protocol ID
- f/2020/166
- Status last verified
- Feb 2021
- First submitted
- 18 Nov 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33689985
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Patients With a Borderline COVID-19 PCR Test Result
- ClinicalTrials.gov ID
- NCT04636294
- Acronym / sponsor ID
- f/2020/166
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result. | – | Diagnostic Test: SARS-CoV-2 PCR |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * Ambulant (majority) * Hospital personnel * Hospitalized patients
Key inclusion criteria (1 listed)
- Every individual that delivers a nasopharyngeal lysate for SARS-CoV-2 RNA determination by PCR.
Key exclusion criteria (1 listed)
- Patients without a previous borderline COVID-19 PCR result within 96 hours are excluded for the follow-up study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 PCRSARS-CoV-2 PCR of nasopharyngeal lysate. | Diagnostic test | COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result. |
Primary outcome
Ratio of positivity conversion after receiving a COVID-19 borderline PCR result.
Time frame: 3 days
1 secondary outcome
Symptoms predicting COVID-19 positivity conversion after receiving a borderline PCR result.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 33689985Boeckmans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Virus, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of positivity conversion after receiving a COVID-19 borderline PCR result. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.