Covid-19COVID AMBU 60NCT04363099
Multicentre Observational Study on Management COVID 19 Positive Outpatients in a French Cluster.
An observational study of Covid-19, run by Maison de Sante Pluridisciplinaire de Creil at 1 site in France.
Trial summary
Since December 2019, a new agent, the coronavirus SARS-Cov-2, has spread from China to the rest of the world causing an international epidemic of respiratory diseases called COVID-19. Oise was one of the first clusters in France, with more than 4,000 confirmed cases. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Covid-19
- What is being tested?
- observational
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 31 Dec 2020
- 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 Up to 99 years
- All sexes
- Child, Adult, Older adult
Study population: ambulatory patients
Who may be able to join
- patients with covid 19 symptoms
- patients who had a contact with a person PCR Covid 19+
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Since December 2019, a new agent, the coronavirus SARS-Cov-2, has spread from China to the rest of the world causing an international epidemic of respiratory diseases called COVID-19. Oise was one of the first clusters in France, with more than 4,000 confirmed cases. A significant proportion (80%) of patients with COVID-19 are ambulatory. However, few data are available for this particular population in France. Thus, few clear recommendations are available.
We propose to conduct a large cohort of observation of suspected or confirmed COVID-19 patients on an ambulatory basis in the Oise region. This observatory will make it possible to describe the epidemiological characteristics and initial management of COVID-19 patients and to identify early severity factors.
- Conditions
- Covid-19
- Being tested
- observational
- Keywords
- ambulatory, outpatients, COVID 19, Oise, France
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
observational management of outpatients COVID 19
| Study group | Role | What they receive |
|---|---|---|
| outpatients COVID 19 positive | Not described Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical description of covid 19 ambulatory cases.
Measured: 3 months
Secondary outcomes (2)
Biological and radiological description of ambulatory cases
Measured: 3 months
Prevalence of positive cases (PCR and/or serological positive)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maison de Sante Pluridisciplinaire de Creil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DIMI Svetlane, Maison de Sante Pluridisciplinaire de Creil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363099
- Sponsor's protocol ID
- 2020-A01059-30
- Acronym
- COVID AMBU 60
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Observational Study on Management COVID 19 Positive Outpatients in a French Cluster.
- ClinicalTrials.gov ID
- NCT04363099
- Acronym / sponsor ID
- COVID AMBU 60 / 2020-A01059-30
- Conditions
- Covid-19
- Keywords
- ambulatory, outpatients, COVID 19, Oise, France
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Maison de Sante Pluridisciplinaire de CreilUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Apr 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.
Since December 2019, a new agent, the coronavirus SARS-Cov-2, has spread from China to the rest of the world causing an international epidemic of respiratory diseases called COVID-19. Oise was one of the first clusters in France, with more than 4,000 confirmed cases. A significant proportion (80%) of patients with COVID-19 are ambulatory. However, few data are available for this particular population in France. Thus, few clear recommendations are available.
We propose to conduct a large cohort of observation of suspected or confirmed COVID-19 patients on an ambulatory basis in the Oise region. This observatory will make it possible to describe the epidemiological characteristics and initial management of COVID-19 patients and to identify early severity factors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatients COVID 19 positive | – | Other: observational |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- ambulatory patients
Key inclusion criteria (2 listed)
- patients with covid 19 symptoms
- patients who had a contact with a person PCR Covid 19+
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| observationalobservational management of outpatients COVID 19 | Other | outpatients COVID 19 positive |
Primary outcome
clinical description of covid 19 ambulatory cases.
Time frame: 3 months
2 secondary outcomes
Biological and radiological description of ambulatory cases
Time frame: 3 months
Prevalence of positive cases (PCR and/or serological positive)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
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 Maison de Sante Pluridisciplinaire de Creil 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svetlane DIMI, M.D (+33650002085, svetlane.dimi@sfr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical description of covid 19 ambulatory cases. (time frame: 3 months). 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 27 Apr 2020.