EmergenciesEPRICODNCT04422587
Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea
An observational study of Emergencies, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This research aims to improve our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 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 7 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 15 years 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
This research aims to improve our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 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.
A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However, virological tests do not currently allow rapid results for COVID-19.
Research project of investigatory aims to develop a predictive model of the risk of being COVID-19 positive for patients admitted to the emergency room for acute dyspnea.
- Conditions
- Emergencies
- Being tested
- RECOP unit patient
- Keywords
- COVID-19, diagnostic strategy, acute dyspnea
- 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.
| Study group | Role | What they receive |
|---|---|---|
| RECOP unit patient | 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. Receives: Other: RECOP unit patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a predictive model of the risk of being COVID-19 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: inclusion day
Secondary outcomes (3)
Describe the characteristics of patients admitted to reCOP units according to their virological status
The COVID-19 virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking
Measured: 30 days
Virological status
Virological status will be collected by a phone call at the patient
Measured: 30 days
Mortality status
Mortality status will be collected by a phone call at the patient
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start13 Mar 2020
- Primary completion5 Jun 2020
- Study completion7 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
- Other
- 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
- Paul-Henri Auboiroux, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422587
- Sponsor's protocol ID
- RC31/20/0149
- Acronym
- EPRICOD
- Status last verified
- Nov 2020
- First submitted
- 5 Jun 2020
- Last updated
- 5 Nov 2020
- 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea
- ClinicalTrials.gov ID
- NCT04422587
- Acronym / sponsor ID
- EPRICOD / RC31/20/0149
- Conditions
- Emergencies
- Keywords
- COVID-19, diagnostic strategy, acute dyspnea
- 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
- 7 Jun 2020 (actual)
- First posted
- 9 Jun 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 our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 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.
A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However, virological tests do not currently allow rapid results for COVID-19.
Research project of investigatory aims to develop a predictive model of the risk of being COVID-19 positive for patients admitted to the emergency room for acute dyspnea.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RECOP unit patient | – | Other: 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. |
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 15 years 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. | Other | RECOP unit patient |
Primary outcome
Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea
Time frame: inclusion day
demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor
3 secondary outcomes
Describe the characteristics of patients admitted to reCOP units according to their virological status
Time frame: 30 days
Virological status
Time frame: 30 days
Mortality status
Time frame: 30 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 5 Nov 2020.
- 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.
Paul-Henri Auboiroux, 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 5 Nov 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?
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?
Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea (time frame: inclusion day). 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 5 Nov 2020.