COVID-19 Serological Testing of Patients With a Mental Disorder From the Catchment Area of the Capital Region of Denmark

NCT ID: NCT04775407

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1355 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2021-06-01

Brief 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. 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.

Conditions

Covid19; Severe Mental Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Screening

Serological SARS-CoV-2 test

blood sampling

Intervention Type: PROCEDURE

IgM og IgG analysis

Interventions

blood sampling

IgM og IgG analysis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Informed oral and written consent

2. Age ≥ 18 years

3. 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))

4. Receiving psychiatric treatment from a hospital in- or outpatient-clinic in the catchment area of the Capital Region of Denmark

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anders Fink-Jensen, MD, DMSci

OTHER

Sponsor Role: lead

Responsible Party

Anders Fink-Jensen, MD, DMSci

MD Proffessor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Psychiatric Centre Copenhagen

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 35231037 (View on PubMed)

Other Identifiers

COVID-19 RHP

Identifier Type: -

Identifier Source: org_study_id