Primary Care : Suspected and Confirmed Cases of COVID-19SOPRACNCT05124145
Primary Care in AURA for COVID-19
An observational study of Primary Care : Suspected and Confirmed Cases of COVID-19 and Primary Health Care, run by Research on Healthcare Performance Lab U1290 at 1 site in France.
Trial summary
As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Care : Suspected and Confirmed Cases of COVID-19, Primary Health Care, COVID-19 Pandemic
- How many people
- 7,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 5 Nov 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients consulting a health professional in primary care in the AURA region, by physical encounter, visio-consultation or telephone call, during the COVID-19 epidemics period
Who may be able to join
- Suspect or confirmed COVID-19 case consulting in primary care in the Aura region
Who cannot join
- Patient with a COVID-19 diagnosis excluded after clinical examination or investigation.
- Patient refusing to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network
As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.
- Conditions
- Primary Care : Suspected and Confirmed Cases of COVID-19, Primary Health Care, COVID-19 Pandemic
- Being tested
- No intervention (surveillance system)
- Keywords
- COVID-19, Primary care, Clinical epidemiology, Practice assessment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (surveillance system)Other
The surveillance network will collect data on all consecutive COVID-19 cases
| Study group | Role | What they receive |
|---|---|---|
| surveillance network | The surveillance network is made of 200 health professionals from 85 practices Receives: Other: No intervention (surveillance system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the weekly incidence of COVID-19 confirmed cases
Confirmed cases will be defined by the positivity of the detection of SARS-CoV-2 in RT-PCR and possibly by serology (for patients in whom a test is performed).
The incidence rate of confirmed cases will be estimated from the number of new cases confirmed by a positive biological test reported in the patient population of the participating facilities.
Measured: 30 days after the COVID-19 suspected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Apr 2020
- Primary completion2 Nov 2020
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Care : Suspected and Confirmed Cases of COVID-19Studies 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 only
- Time perspective
- Other
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research on Healthcare Performance Lab U1290
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent LETRILLART, MD, PhD, Principal investigator, Research on Healthcare Performance Lab U1290
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124145
- Sponsor's protocol ID
- SOPRAC
- Acronym
- SOPRAC
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 26 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 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network
- ClinicalTrials.gov ID
- NCT05124145
- Acronym / sponsor ID
- SOPRAC / SOPRAC
- Conditions
- Primary Care : Suspected and Confirmed Cases of COVID-19, Primary Health Care, COVID-19 Pandemic
- Keywords
- COVID-19, Primary care, Clinical epidemiology, Practice assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Research on Healthcare Performance Lab U1290University, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 17 Nov 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.
As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surveillance network | – | Other: No intervention (surveillance system)The surveillance network is made of 200 health professionals from 85 practices |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting a health professional in primary care in the AURA region, by physical encounter, visio-consultation or telephone call, during the COVID-19 epidemics period
Key inclusion criteria (1 listed)
- Suspect or confirmed COVID-19 case consulting in primary care in the Aura region
Key exclusion criteria (2 listed)
- Patient with a COVID-19 diagnosis excluded after clinical examination or investigation.
- Patient refusing to participate to the 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 |
|---|---|---|
| No intervention (surveillance system)The surveillance network will collect data on all consecutive COVID-19 cases | Other | surveillance network |
Primary outcome
Estimation of the weekly incidence of COVID-19 confirmed cases
Time frame: 30 days after the COVID-19 suspected
Confirmed cases will be defined by the positivity of the detection of SARS-CoV-2 in RT-PCR and possibly by serology (for patients in whom a test is performed). The incidence rate of confirmed cases will be estimated from the number of new cases confirmed by a positive biological test reported in the patient population of the participating facilities.
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 26 Nov 2021.
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.
Laurent LETRILLART, MD, PhD principal investigator
Research on Healthcare Performance Lab U1290
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 Primary Care : Suspected and Confirmed Cases of COVID-19 and Primary Health Care, run by Research on Healthcare Performance Lab U1290 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 26 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?
Estimation of the weekly incidence of COVID-19 confirmed cases (time frame: 30 days after the COVID-19 suspected). 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 26 Nov 2021.