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

NCT04775407 | Terminated

• 1 other identifier: COVID-19 RHP
• Study Type: observational
• Target: 1,355
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Severe Mental Disorder

Outcome Measures

Primary Outcomes (1)

• The incidence of positive serological COVID-19 test result

  A blood sample from each patient is analyzed for COVID-19 antibodies

  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).

  18 month

Study Arms (1)

Screening

Serological SARS-CoV-2 test

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

IgM og IgG analysis

Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Anders Fink-Jensen, MD, DMSci: lead

Study Sites (1)

Psychiatric Centre Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35231037 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling for SARS-CoV-2 antibodies analysis

MeSH Terms

Conditions

COVID-19; Mental Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Proffessor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 1, 2021
• Study Start: January 18, 2021
• Primary Completion: February 20, 2021
• Study Completion: June 1, 2021
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)