COVIDCOVIDIMMUNOPSYNCT04381845
Immunity and Infections in the Psychiatric Population
A study testing COVID19 immunization testing in people with COVID and Psychiatric Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients. The secondary objective of this cohort follow-up is to: 1. Clinically characterize COVID patients who are positive for serological testing 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Psychiatric Disorders
- What is being tested?
- COVID19 immunization testing
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2021to 10 Dec 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
- Adult patient
- Hospitalized in one of the participating psychiatric wards during the inclusion period
- Signed informed consent
Who cannot join
- Inability to obtain the consent of the patient or legal representative, if applicable
- Patient under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris
Paris, Île-de-France Region
Isabelle Vivaldo, isabelle.vivaldo@aphp.fr
Pierre-André Natella, PharmD, pierre.natella@aphp.fr
About this study
Official title: Immunity and COVID Infections in the Psychiatric Population
The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients.
The secondary objective of this cohort follow-up is to:
- Clinically characterize COVID patients who are positive for serological testing
- Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis
- Immunologically characterize COVID patients who are positive for serological testing
- Exploring the links between susceptibility to COVID19 and erythrocytic blood groups
Read the detailed description
All patients accepting to participate will be included in participating psychiatry services and will have a COVID Serological Test for Inclusion with confirmation at J15 including immune-genetics data.
A Comparison of COVID patients versus no COVID patients will be based on a clinical examination (psychiatric, somatic) and blood samples collected at J0 and J15.
- Conditions
- COVID, Psychiatric Disorders
- Being tested
- COVID19 immunization testing
- Keywords
- COVID infection, psychiatric population
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID19 immunization testingDiagnostic test
serological COVID19 test with confirmation at J15 during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| psychiatric patient | Other | patients who are hospitalized in psychiatric department Receives: Diagnostic Test: COVID19 immunization testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of COVID-positive patients
Number of COVID-positive patients, defined by a positive serological test result by immuno-chromatography at inclusion or at 15 days.
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start10 Jan 2021
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion LEBOYER, PHD, Principal investigator, Assistance Publique des Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381845
- Sponsor's protocol ID
- APHP200553
- Acronym
- COVIDIMMUNOPSY
- Status last verified
- Feb 2023
- First submitted
- 6 May 2020
- Last updated
- 15 May 2023
- 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 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunity and COVID Infections in the Psychiatric Population
- ClinicalTrials.gov ID
- NCT04381845
- Acronym / sponsor ID
- COVIDIMMUNOPSY / APHP200553
- Conditions
- COVID, Psychiatric Disorders
- Keywords
- COVID infection, psychiatric population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 11 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.
The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients.
The secondary objective of this cohort follow-up is to:
- Clinically characterize COVID patients who are positive for serological testing
- Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis
- Immunologically characterize COVID patients who are positive for serological testing
- Exploring the links between susceptibility to COVID19 and erythrocytic blood groups
Detailed description
All patients accepting to participate will be included in participating psychiatry services and will have a COVID Serological Test for Inclusion with confirmation at J15 including immune-genetics data.
A Comparison of COVID patients versus no COVID patients will be based on a clinical examination (psychiatric, somatic) and blood samples collected at J0 and J15.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psychiatric patient | Other | Diagnostic Test: COVID19 immunization testingpatients who are hospitalized in psychiatric department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient
- Hospitalized in one of the participating psychiatric wards during the inclusion period
- Signed informed consent
Key exclusion criteria (2 listed)
- Inability to obtain the consent of the patient or legal representative, if applicable
- Patient under safeguard of justice
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 |
|---|---|---|
| COVID19 immunization testingserological COVID19 test with confirmation at J15 during hospitalization | Diagnostic test | psychiatric patient |
Primary outcome
Number of COVID-positive patients
Time frame: day 15
Number of COVID-positive patients, defined by a positive serological test result by immuno-chromatography at inclusion or at 15 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- 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.
Marion LEBOYER, PHD principal investigator
Assistance Publique des Hopitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID19 immunization testing in people with COVID and Psychiatric Disorders, run by Assistance Publique - Hôpitaux de Paris 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: status not confirmed, as of the sponsor's last update on 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact France GUYOT (0144841751 ext. 33, france.guyot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of COVID-positive patients (time frame: day 15). 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 15 May 2023.