Covid19NCT04775407
COVID-19 Serological Testing of Patients With a Mental Disorder From the Catchment Area of the Capital Region of Denmark
An observational study of Covid19 and Severe Mental Disorder, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
Trial summary
The pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has lately caused worldwide health problems. Patients suffering from a severe mental disorder are at increased risk for infectious diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Severe Mental Disorder
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 1,355 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jan 2021to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is patients diagnosed with schizophrenia, schizoaffective disorder or a bipolar affective disorder receiving in-patient or out-patient care via one of the psychiatric centres in The Mental Health Services in the Capital Region of Denmark
Who may be able to join
- Informed oral and written consent
- Age ≥ 18 years
- Patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder, according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO))
- Receiving psychiatric treatment from a hospital in- or outpatient-clinic in the catchment area of the Capital Region of Denmark
Who cannot join
- 1. Patient with signs of infection should initially be transferred to the national test centres antigen-PCR testing. These patients will be offered to participate in next blood sampling interval.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Serological Testing of Patients With a Diagnosis of Schizophrenia, Schizoaffective Disorder or Bipolar Affective Disorder From the Catchment Area of the Capital Region of Denmark
The pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has lately caused worldwide health problems. Patients suffering from a severe mental disorder are at increased risk for infectious diseases. The primary aim of the present surveillance study is to perform COVID-19 serological testing on patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder. Patients from the catchment area of the Capital Region of Denmark will be COVID-19 tested at baseline (0 months) and again at 6 and 12 months, in order to follow the spread of COVID-19 among this vulnerable patient population.
Read the detailed description
Patients suffering from severe mental illness could be in increased risk for a severe outcome if infected with COVID-19. Also, there are reports on fewer treatment activities among psychiatric patients (e.g. higher heart disease mortality), lower hospitalization rate and fewer invasive cardiac procedures among persons with schizophrenia than among the general population. This conveys a risk not only for the patient but for the spread of COVID-19 in the community. At present, we expect the outcome of a COVID-19 infection to be worse among the mentioned psychiatric patient population, but whether the spread of COVID-19 differs from the pattern observed in the general population is unknown. This information is of pivotal interest to come up with sufficient treatment strategies - especially when facing a possible second surge in the COVID-19 spread. Moreover, it is to the best of our knowledge unknown whether a possible CNS COVID-19 infection will worsen existing psychopathology among patients with severe schizophrenia, schizoaffective- or bipolar affective disorder. The study is exploratory in nature including as many patients as possible for testing. The target population is patients diagnosed with schizophrenia, schizoaffective disorder or a bipolar affective disorder receiving in-patient or out-patient care via one of the psychiatric centres in The Mental Health Services in the Capital Region of Denmark. Each patient will attend 3 study visits during a period of 12 months. A blood sample for IgG and IgM analysis for will be drawn at every visit.
- Conditions
- Covid19, Severe Mental Disorder
- Being tested
- blood sampling
- Medical subject headings
- COVID-19, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
IgM og IgG analysis
| Study group | Role | What they receive |
|---|---|---|
| Screening | Serological SARS-CoV-2 test Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of positive serological COVID-19 test result
A blood sample from each patient is analyzed for COVID-19 antibodies
Measured: 18 month
Secondary outcomes (1)
Registered death (number), hospital admissions (number), changes in out-patients clinic contacts (number), changes in suicidal behavior (score on medical scale) and changes in psychopharmacological treatment (registered changed in medial journal).
Data from Danish registers and from patient medical records are correlated with the possible presence of COVID-19 antibodies
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start18 Jan 2021
- Primary completion20 Feb 2021
- Study completion1 Jun 2021
Why it stopped: Due to the development of the pandemic
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 Covid19Studies 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
- Prospective
- Enrolment
- 1,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775407
- Sponsor's protocol ID
- COVID-19 RHP
- Status last verified
- Sep 2022
- First submitted
- 22 Feb 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sass MR, Juul TS, Skov R, Iversen K, Harritshoj LH, Sorensen E, Ostrowski SR, Andersen O, Ekstrom CT, Ullum H, Nielsen J, Hageman I, Fink-Jensen A. SARS-CoV-2 seroprevalence among patients with severe mental illness: A cross-sectional study. PLoS One. 2022 Mar 1;17(3):e0264325. doi: 10.1371/journal.pone.0264325. eCollection 2022.
PubMed 35231037
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Serological Testing of Patients With a Diagnosis of Schizophrenia, Schizoaffective Disorder or Bipolar Affective Disorder From the Catchment Area of the Capital Region of Denmark
- ClinicalTrials.gov ID
- NCT04775407
- Acronym / sponsor ID
- COVID-19 RHP
- Conditions
- Covid19, Severe Mental Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the development of the pandemic
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 1 Mar 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.
The pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has lately caused worldwide health problems. Patients suffering from a severe mental disorder are at increased risk for infectious diseases. The primary aim of the present surveillance study is to perform COVID-19 serological testing on patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder. Patients from the catchment area of the Capital Region of Denmark will be COVID-19 tested at baseline (0 months) and again at 6 and 12 months, in order to follow the spread of COVID-19 among this vulnerable patient population.
Detailed description
Patients suffering from severe mental illness could be in increased risk for a severe outcome if infected with COVID-19. Also, there are reports on fewer treatment activities among psychiatric patients (e.g. higher heart disease mortality), lower hospitalization rate and fewer invasive cardiac procedures among persons with schizophrenia than among the general population. This conveys a risk not only for the patient but for the spread of COVID-19 in the community. At present, we expect the outcome of a COVID-19 infection to be worse among the mentioned psychiatric patient population, but whether the spread of COVID-19 differs from the pattern observed in the general population is unknown. This information is of pivotal interest to come up with sufficient treatment strategies - especially when facing a possible second surge in the COVID-19 spread. Moreover, it is to the best of our knowledge unknown whether a possible CNS COVID-19 infection will worsen existing psychopathology among patients with severe schizophrenia, schizoaffective- or bipolar affective disorder. The study is exploratory in nature including as many patients as possible for testing. The target population is patients diagnosed with schizophrenia, schizoaffective disorder or a bipolar affective disorder receiving in-patient or out-patient care via one of the psychiatric centres in The Mental Health Services in the Capital Region of Denmark. Each patient will attend 3 study visits during a period of 12 months. A blood sample for IgG and IgM analysis for will be drawn at every visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Procedure: blood samplingSerological SARS-CoV-2 test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is patients diagnosed with schizophrenia, schizoaffective disorder or a bipolar affective disorder receiving in-patient or out-patient care via one of the psychiatric centres in The Mental Health Services in the Capital Region of Denmark
Key inclusion criteria (4 listed)
- Informed oral and written consent
- Age ≥ 18 years
- Patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder, according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO))
- Receiving psychiatric treatment from a hospital in- or outpatient-clinic in the catchment area of the Capital Region of Denmark
Key exclusion criteria (1 listed)
- 1. Patient with signs of infection should initially be transferred to the national test centres antigen-PCR testing. These patients will be offered to participate in next blood sampling interval.
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 samplingIgM og IgG analysis | Procedure or surgery | Screening |
Primary outcome
The incidence of positive serological COVID-19 test result
Time frame: 18 month
A blood sample from each patient is analyzed for COVID-19 antibodies
1 secondary outcome
Registered death (number), hospital admissions (number), changes in out-patients clinic contacts (number), changes in suicidal behavior (score on medical scale) and changes in psychopharmacological treatment (registered changed in medial journal).
Time frame: 18 month
Results and safety
The study was stopped early (reason given: Due to the development of the pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 35231037Sass MR, Juul TS, Skov R, Iversen K, Harritshoj LH, Sorensen E, Ostrowski SR, Andersen O, Ekstrom CT, Ullum H, Nielsen J, Hageman I, Fink-Jensen A. SARS-CoV-2 seroprevalence among patients with severe mental illness: A cross-sectional study. PLoS One. 2022 Mar 1;17(3):e0264325. doi: 10.1371/journal.pone.0264325. eCollection 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Severe Mental Disorder, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
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 4 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: stopped early, as of the sponsor's last update on 7 Sep 2022. 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 Denmark. 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 stopped early (reason given: Due to the development of the pandemic). Results are not available in the source record.
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 incidence of positive serological COVID-19 test result (time frame: 18 month). 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 NCT04775407, 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 7 Sep 2022.