HomelessCOVIDHomelessNCT04408131
Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study
A study testing Blood sample in people with Homeless, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population. The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homeless
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2020to 30 May 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in the city of Marseille
- Being homeless
- Be over 18 years of age
Who cannot join
- Persons under guardianship
- Persons who refused to sign the research consent
Trial locations and contacts
1 site in 1 country.
About this study
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.
The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).
Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.
- Conditions
- Homeless
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
virological test
Blood sampleBiological
serological test
| Study group | Role | What they receive |
|---|---|---|
| Homeless people | Experimental | Blood sample Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
the covid mortality rate
The mortality rate is determined by the initial clinical diagnosis and follow-up of the patient by the field team.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start28 May 2020
- Primary completion27 Jan 2021 (estimated)
- Study completion30 May 2023
Why it stopped: study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HomelessStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408131
- Sponsor's protocol ID
- 2020-32
- Other IDs
- 2020-A01398-31
- Acronym
- COVIDHomeless
- Status last verified
- May 2023
- First submitted
- 28 May 2020
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mosnier E, Loubiere S, Monfardini E, Alibert A, Landier J, Ninoves L, Bosetti T, Auquier P, Mosnier M, Wakap SN, Warszawski J, Tinland A. Cumulative incidence of SARS-CoV-2 infection within the homeless population: insights from a city-wide longitudinal study. BMJ Open. 2023 Feb 23;13(2):e065734. doi: 10.1136/bmjopen-2022-065734.
PubMed 36822808
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study
- ClinicalTrials.gov ID
- NCT04408131
- Acronym / sponsor ID
- COVIDHomeless / 2020-32
- Conditions
- Homeless
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 27 Jan 2021 (estimated)
- Study completion
- 30 May 2023 (actual)
- First posted
- 29 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.
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.
The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).
Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Homeless people | Experimental | Biological: Blood sampleBlood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Living in the city of Marseille
- Being homeless
- Be over 18 years of age
Key exclusion criteria (2 listed)
- Persons under guardianship
- Persons who refused to sign the research consent
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 |
|---|---|---|
| Blood samplevirological test | Biological | Homeless people |
| Blood sampleserological test | Biological | Homeless people |
Primary outcome
the covid mortality rate
Time frame: 90 days
The mortality rate is determined by the initial clinical diagnosis and follow-up of the patient by the field team.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 36822808Mosnier E, Loubiere S, Monfardini E, Alibert A, Landier J, Ninoves L, Bosetti T, Auquier P, Mosnier M, Wakap SN, Warszawski J, Tinland A. Cumulative incidence of SARS-CoV-2 infection within the homeless population: insights from a city-wide longitudinal study. BMJ Open. 2023 Feb 23;13(2):e065734. doi: 10.1136/bmjopen-2022-065734.
- 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.
Jean-Olivier ARNAUD, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Homeless, run by Assistance Publique Hopitaux De Marseille 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 3 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: withdrawn, as of the sponsor's last update on 31 May 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
the covid mortality rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408131, which also lists 1 linked publication.
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 31 May 2023.