EmergenciesRECOPNCT04371328
Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection
An observational study of Emergencies, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Emergencies
- What is being tested?
- RECOP unit patient
- How many people
- 1,860 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2020to 30 Jun 2020
- How long will I take part?
- 1 Month
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial
Who may be able to join
- All patients over the age of 15 admitted to the RECOP unit for dyspnea
Who cannot join
- Patient admitted to shock for respiratory distress requiring immediate respiratory support.
- Patient under justice safeguard
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection (Unit "COVID Possible")
This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units.
The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units.
This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.
- Conditions
- Emergencies
- Being tested
- RECOP unit patient
- Keywords
- COVID 19, aspecific respiratory symptomatology
- Medical subject headings
- Emergencies, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECOP unit patientOther
All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified.
30 days after inclusion, virological status and mortality will be collect
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the characteristics of patients admitted to reCOP units according to their virological status vis-à-vis COVID-19
The virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking
Measured: 30 days
Secondary outcomes (1)
Develop a predictive model of the risk of being COVID for patients admitted to the emergency room for dyspnea
demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start13 Mar 2020
- Primary completion5 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prospective
- Enrolment
- 1,860 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Balen, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371328
- Sponsor's protocol ID
- RC31/20/0094
- Acronym
- RECOP
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- 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 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection (Unit "COVID Possible")
- ClinicalTrials.gov ID
- NCT04371328
- Acronym / sponsor ID
- RECOP / RC31/20/0094
- Conditions
- Emergencies
- Keywords
- COVID 19, aspecific respiratory symptomatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,860 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 May 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.
This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units.
The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units.
This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial
Key inclusion criteria (1 listed)
- All patients over the age of 15 admitted to the RECOP unit for dyspnea
Key exclusion criteria (2 listed)
- Patient admitted to shock for respiratory distress requiring immediate respiratory support.
- Patient under justice safeguard
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 |
|---|---|---|
| RECOP unit patientAll patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified. 30 days after inclusion, virological status and mortality will be collect | Other | – |
Primary outcome
Describe the characteristics of patients admitted to reCOP units according to their virological status vis-à-vis COVID-19
Time frame: 30 days
The virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking
1 secondary outcome
Develop a predictive model of the risk of being COVID for patients admitted to the emergency room for dyspnea
Time frame: 0 days
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 8 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Frédéric Balen, MD principal investigator
University Hospital of Toulouse
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 Emergencies, run by University Hospital, Toulouse 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 2 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 8 Oct 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?
Describe the characteristics of patients admitted to reCOP units according to their virological status vis-à-vis COVID-19 (time frame: 30 days). 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 8 Oct 2021.