The Gold Standard for Current SARS CoV2 Detection is RT-PCRNCT04339686
Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening.
An observational study of The Gold Standard for Current SARS CoV2 Detection is RT-PCR, run by Poitiers University Hospital at 1 site in France.
Trial summary
All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- The Gold Standard for Current SARS CoV2 Detection is RT-PCR
- What is being tested?
- Thoracic CT Scan
- How many people
- 56,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2020to Nov 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients suspected of COVID 19 consulting for diagnostic
Who may be able to join
- All patients suspected of COVID 19 consulting for diagnostic
Who cannot join
- Delay between RT-PCR and Thoracic Scan greater than 6 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening. Comparison to Virological Testing and Multiparametric Gold Standard
All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health.
To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID.
Read more
CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary.
Ct Scan performance will be recorded and analyzed.
- Being tested
- Thoracic CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic CT ScanDiagnostic test
Retrospective analysis of the thoracic CT scan results compared to final discharge summary
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of COVID 19 | Not described Receives: Diagnostic Test: Thoracic CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of chest CT in screening for pulmonary lesions in clinical suspicions of COVID.
CT Report will dichotomized into evocative or non-evocative for COVID-related lung injury.
Measured: 1 month
Secondary outcomes (1)
Compare the diagnostic performance of chest CT and RT-PCR in COVID 19 at the initial consultation (screening).
Initial virological RT-PCR results: positive or negative depending on the laboratories of the institutions.
Scanner results according to French Thoracic Imaging Society.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start20 Apr 2020
- Primary completionSep 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Gold Standard for Current SARS CoV2 Detection is RT-PCRStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339686
- Sponsor's protocol ID
- POWER-COVID_CT
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening. Comparison to Virological Testing and Multiparametric Gold Standard
- ClinicalTrials.gov ID
- NCT04339686
- Acronym / sponsor ID
- POWER-COVID_CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56,000 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 9 Apr 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.
All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health.
To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID.
CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary.
Ct Scan performance will be recorded and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of COVID 19 | – | Diagnostic Test: Thoracic CT Scan |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients suspected of COVID 19 consulting for diagnostic
Key inclusion criteria (1 listed)
- All patients suspected of COVID 19 consulting for diagnostic
Key exclusion criteria (1 listed)
- Delay between RT-PCR and Thoracic Scan greater than 6 days.
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 |
|---|---|---|
| Thoracic CT ScanRetrospective analysis of the thoracic CT scan results compared to final discharge summary | Diagnostic test | Suspicion of COVID 19 |
Primary outcome
Diagnostic performance of chest CT in screening for pulmonary lesions in clinical suspicions of COVID.
Time frame: 1 month
CT Report will dichotomized into evocative or non-evocative for COVID-related lung injury.
1 secondary outcome
Compare the diagnostic performance of chest CT and RT-PCR in COVID 19 at the initial consultation (screening).
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
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.
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 The Gold Standard for Current SARS CoV2 Detection is RT-PCR, run by Poitiers University Hospital at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 28 Apr 2020. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume HERPE (681196778 ext. +33, guillaume.herpe@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of chest CT in screening for pulmonary lesions in clinical suspicions of COVID. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2020.