Covid19 Clinical Trial
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
NCT number | NCT04775407 |
Other study ID # | COVID-19 RHP |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 18, 2021 |
Est. completion date | June 1, 2021 |
Verified date | September 2022 |
Source | Psychiatric Centre Rigshospitalet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 1355 |
Est. completion date | June 1, 2021 |
Est. primary completion date | February 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Psychiatric Centre Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Anders Fink-Jensen, MD, DMSci |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of positive serological COVID-19 test result | A blood sample from each patient is analyzed for COVID-19 antibodies | 18 month | |
Secondary | 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 |
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