COVID-19EFFI-COVID-19NCT05077228
Efficiency of the Imaging Strategy for the Management of Suspected Covid-19
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Emergency departments have been placed at the heart of the patient triage strategy during the COVID-19 epidemic. In the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 28 Oct 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020
Who may be able to join
- Major subject (≥18 years old)
- Subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020
- Subject affiliated to a social health insurance protection scheme
- Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Emergency departments have been placed at the heart of the patient triage strategy during the COVID-19 epidemic. In the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local radiology and virology teams. While the pandemic in France appears to be currently under control, it is important to assess the sorting strategies put in place to deal with a new epidemic.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Dyspnea, Cough, Sputum, Diarrhea, Confusion
- Medical subject headings
- COVID-19, Dyspnea, Cough, Diarrhea, Confusion
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective study of the imaging strategy for the management of suspected Covid-19
Measured: Files analysed retrospectively from March 09, 2020 to May 08, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Oct 2020
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina GARNIER KEPKA, MD, Principal investigator, Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077228
- Sponsor's protocol ID
- 7976
- Acronym
- EFFI-COVID-19
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of the Imaging Strategy for the Management of Suspected Covid-19
- ClinicalTrials.gov ID
- NCT05077228
- Acronym / sponsor ID
- EFFI-COVID-19 / 7976
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Dyspnea, Cough, Sputum, Diarrhea, Confusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 14 Oct 2021 (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.
Emergency departments have been placed at the heart of the patient triage strategy during the COVID-19 epidemic. In the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local radiology and virology teams. While the pandemic in France appears to be currently under control, it is important to assess the sorting strategies put in place to deal with a new epidemic.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020
Key inclusion criteria (4 listed)
- Major subject (≥18 years old)
- Subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020
- Subject affiliated to a social health insurance protection scheme
- Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A retrospective study of the imaging strategy for the management of suspected Covid-19
Time frame: Files analysed retrospectively from March 09, 2020 to May 08, 2020 will be examined]
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 15 Nov 2021.
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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.
Sabrina GARNIER KEPKA, MD principal investigator
Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg
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 COVID-19, run by University Hospital, Strasbourg, France 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 4 inclusion and 3 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 15 Nov 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 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?
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?
A retrospective study of the imaging strategy for the management of suspected Covid-19 (time frame: Files analysed retrospectively from March 09, 2020 to May 08, 2020 will be examined]). 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 15 Nov 2021.