Status: Ongoing First registered on: 28/10/2020
Last updated on: 28/10/2020
1. Study identification
EU PAS Register NumberEUPAS37790
Official titleThe effect of mental disorders and treatment with psychotropic agents on the course of COVID-19
Study title acronymCOVID-19 psychotropics
Study typeObservational study
Brief description of the studyBeyond the psycho-social consequences of the coronavirus disease 2019 (COVID-19) pandemic, people with severe mental disorders, such as schizophrenia and bipolar disorder have been reported with an up to 2-fold increased 30-days risk of death after a severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) positive test. Recent use of psychotropic agents has also been associated with increased risk of death, varying between 50% in users of antidepressants to a three-fold increase in users of antipsychotics. The importance of maintaining and adjusting pharmacological treatment of people with severe mental disorders during the COVID-19 pandemic has been emphasized. Identifying those drugs with lower risk profiles regarding adverse outcomes to COVID-19 will support guidance of selecting and adjusting acute and maintenance treatment during the COVID-19 pandemic. The present study aims at providing a population-based description of the association and potential differential impact of frequently used psychotropic drugs on the course and outcomes of COVID-19 in people with hospital diagnosed and without hospital diagnosed psychiatric disorders. We hypothesize that psychotropic treatment patterns differ between community-treated COVID-19 patients and hospitalized or deceased COVID-19 patients with lower risks for unfavourable outcomes in users of a) aripiprazole, haloperidol, risperidone or paliperidone as oral or short-acting injectable antipsychotics vs. other oral or depot long-acting antipsychotics; b) short-acting benzodiazepines vs. long-acting benzodiazepines; c) SSRIs vs. tricyclic antidepressants. We will use data from the prospectively collected Danish COVID-19 cohort at Statens Serum Institut including all Danish residents tested by the reverse transcriptase polymerase chain reactions (RT-PCR) for SARS-CoV-2.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAU-ADA
Department/Research groupDepartment of Clinical Medicine; Department of Affective Disorders
Organisation/affiliationAarhus University
Website/Homepagehttps://clin.au.dk/en/
Details of (Primary) lead investigator
Title Dr
Last name Gasse
First name Christiane
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

AU-ADA
University of Southern Denmark Pharmacoepi center
Countries in which this study is being conducted
National study

Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed22/07/2020
Start date of data collection27/02/2020
Start date of data analysis29/10/2020
Date of interim report, if expected
Date of final study report29/01/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodySSI50
Research councils
EU funding scheme
OtherAU-ADA Pro bono50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gasse
First name Christiane
Address line 1Palle Juul-Jensens Boulevard 175
Address line 2 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark
Phone number (incl. country code)4551191476 
Alternative phone number 
Fax number (incl. country code) 
Email address cg@clin.au.dk
Public Enquiries
Title Dr 
Last name Gasse 
First name Christiane 
Address line 1Palle Juul-Jensens Boulevard 175 
Address line 2 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark 
Phone number (incl. country code)4551191476 
Alternative phone number 
Fax number (incl. country code) 
Email address cg@clin.au.dk 
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