SARS-CoV2COPREGNCT04615676
Prospective Evaluation of the Predictive Criteria of Severity for Respiratory Infection Due to COVID-19 Virus
An observational study of SARS-CoV2, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- SARS-CoV2
- What is being tested?
- Follow-up phone call
- How many people
- 4,734 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 17 Jul 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 (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected
Who may be able to join
- patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID
Who cannot join
- unknown contact facility
- call not regulated by a practitioner from the medical emergency help team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Predictive Criteria of Severity Related to Patient Calling Emergency Centre for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID-19.
Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.
- Conditions
- SARS-CoV2
- Being tested
- Follow-up phone call
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up phone callOther
Follow-up phone call after month to detect which patient have been hospitalized
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
Hospitalization declared by the patient 1 month after his call to the emergency call center
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start27 Apr 2020
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2Studies 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
- 4,734 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles-Henri HOUZE-CERFON, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615676
- Sponsor's protocol ID
- RC31/20/0141
- Acronym
- COPREG
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Predictive Criteria of Severity Related to Patient Calling Emergency Centre for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID-19.
- ClinicalTrials.gov ID
- NCT04615676
- Acronym / sponsor ID
- COPREG / RC31/20/0141
- Conditions
- SARS-CoV2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,734 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 4 Nov 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.
Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.
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 (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected
Key inclusion criteria (1 listed)
- patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID
Key exclusion criteria (2 listed)
- unknown contact facility
- call not regulated by a practitioner from the medical emergency help team
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 |
|---|---|---|
| Follow-up phone callFollow-up phone call after month to detect which patient have been hospitalized | Other | – |
Primary outcome
Hospitalization
Time frame: Month 1
Hospitalization declared by the patient 1 month after his call to the emergency call center
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 9 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Charles-Henri HOUZE-CERFON principal investigator
University Hospital, 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 SARS-CoV2, 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 9 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?
Hospitalization (time frame: Month 1). 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 9 Nov 2020.