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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19; Severe Mental Disorder
• Intervention / Treatment: Procedure: blood sampling

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 Type: Observational
• Enrollment (Actual): 1355

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Psychiatric Centre Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Screening; Serological SARS-CoV-2 test	Procedure: blood sampling; IgM og IgG analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of positive serological COVID-19 test result	A blood sample from each patient is analyzed for COVID-19 antibodies	18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 month

Collaborators and Investigators

• Sponsor: Anders Fink-Jensen, MD, DMSci

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; COVID-19; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: COVID-19 RHP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No