Registration analyses of Danish Covid-19 patients

Updated 15 May 2020

The purpose is to establish a cohort of all Danish COVID-19 patients that is continuously updated and linked to the existing Danish health and administrative registries. This will allow analyzes of how drugs, demographic factors and diseases affect the course of COVID-19.

Ressources (description of data and data structure etc.) 

The Danish COVID-19 cohort includes all Danish patients with verified COVID-19 from February 27, 2020 onwards. The cohort is identified using of the Danish Microbiology Database (MiBa) which automatically receives test responses from the country's microbiological departments and Statens Serum Institut.The cohort includes only COVID-19 positive patients, and not patients with negative test response. Data includes  date of positive RT-PCR SARS-CoV-2 test . In addition, the hospitalization date and discharge date associated with the COVID-19 infection are available along with indicator variables (yes/no) for treatment in intensive care unit and use of ventilator. Information on date of birth, gender, migrations and potential date of death is obtained from Civil Registration System (CPR-registeret).

Data is collected on all somatic and psychiatric diagnoses and procedures from The Danish National Patient Registry (LPR-3, Landspatientregisteret) from the beginning of registration to 2018. Data from 2019 is based on LPR-3 and is also available. However, this data is not yet validated and may be incomplete. Data on previously redeemed prescriptions including date, drug name and -class, strength, form of administration, as well as the size and number of packs available fromThe Danish National Prescription Registry (Lægemiddelstatistikregisteret). There are no data on medicines administered during hospital admissions. The Danish Patient Safety Authorization Register is used to classify individuals below 65 years of age as health care professionals.. All data is stored in pseudonymized on the Danish Health Data Authority’s research machine.

You can also apply for access to the used data sources via Forskerservice, incl. MiBa data from May 5, 2020 (in Danish)

Project organization and steering committee

The project has been initiated by the Danish Medicines Agency. A steering committee has been set up to decide which tasks and analyzes the expert group should carry out and to prioritize between them as the expert group acts on instructions from the authorities. The Danish Medicines Agency will serve as secretariat for the steering committee. The expert group will continuously update the steering committee members. The Danish Medicines Agency's Data Analytic Center (DAC) is the project owner and Professor Anton Pottegård at SDU is the project manager on behalf of the Danish Medicines Agency.

Steering committee 

  • Jesper Kjær (The Danish Medicines Agency's Data Analytic Center)
  • Katarina Gesser (The Danish Health Authority)
  • Kåre Mølbak (Staten’s Serum Institut)
  • Tine Jess (Staten’s Serum Institut)
  • Jan Poulsen (The Danish Health Data Authority)
  • Morten Freil (Danish Patients)
  • Erik Jylling (Danish Regions)
  • Jens Winther Jensen (Danish Regions Clinical Quality Program)
  • Ole Skøtt (University of Southern Denmark, Representative of the Danish Faculties of Health Science)
  • Nikolai C. Brun (The Danish Medicines Agency) and Anton Pottegård (University of Southern Denmark) participates in the steering committee as representatives of the expert group.

The expert group

The Danish Medicines Agency has set up an epidemiological expert group, which, under the mandate of the Danish Medicines Agency, is working to establish a database of COVID-19 patients.

  • Prof. Anton Pottegård, University of Southern Denmark
  • Prof. Jesper Hallas, University of Southern Denmark
  • Prof. Henrik Toft Sørensen, Aarhus University
  • Lektor Reimar W. Thomsen, Aarhus University
  • Lektor Christian Fynbo Christiansen, Aarhus University
  • Marianne Kragh Thomsen, Aarhus University Hospital
  • Steffen Christensen, Aarhus University Hospital
  • Henrik Støvring, Aarhus University Hospital
  • Marianne Voldstedlund, Statens Serum Institut
  • Nanna Borup Johansen, The Danish Medicines Agency
  • Nikolai C. Brun, The Danish Medicines Agency

In addition, additional personnel to the necessary extent from all organizations, e.g. junior researchers, statisticians and analytical capacity.

Projects

Use of NSAIDs and risk of critical adverse outcomes in patients with COVID-19

Synopsis: NSAID (pdf)

Protocol: NSAID (pdf)

Link to EU-PAS registration: http://www.encepp.eu/encepp/viewResource.htm?id=34735

Renin–angiotensin–aldosterone system inhibitors and severe outcomes in patients with COVID-19 

Synopsis: Renin–angiotensin–aldosterone (pdf)

Protocol, Renin–angiotensin–aldosterone (pdf)

Link to EU-PAS registration: http://www.encepp.eu/encepp/viewResource.htm?id=34888

The role of inhaled anti-inflammatory pharmaceuticals in COVID-19 incidence, morbidity, and mortality

Synopsis: Inhaled anti-inflammatory pharmaceuticals (pdf)

Protocol:

Link to EU-PAS registration:

Prognosis of coronavirus disease in patients with immune-mediated inflammatory diseases treated with immunomodulating agents and biologics 

Synopsis: Immunomodulating agents (pdf)

Protocol:

Link to EU-PAS registration:

Risk of venous thromboembolism in patients with COVID-19: A nationwide, population-based matched cohort study 

Synopsis: VTE (pdf)

Protocol:

Link to EU-PAS registration:

Impact of use of proton pump inhibitors on susceptibility to infection and risk of severe outcomes in patients with COVID-19

Synopsis: PPI (pdf)

Protocol:

Link to EU-PAS registration:

 

Opportunities and requirements when enrolling ideas

Suggestions of analysis can be submitted via email to The Data Analytics Center here

It is important that the submitter understands that there will be 100% transparency in relation to the analysis proposal and publication of their data and analyzes will occur shortly. In addition, the project team must declare impartiality in relation to any sponsorship and cooperation with the industry which will also be published.

The following form requirements for submitted analyzes must be met 

  • Synopsis, in English, with description of the project of approx. 200-250 words, with brief description of: 
    • Problem/background
    • Purpose
    • E.g. patient group
  • Description of project group and CV, including whether the group has previously demonstrated the performance of this type of analysis
  • Declared impartiality
  • The position to which of the following categories the analysis belongs (one or more): 
    • Suggestions that are important for the short-term COVID-19 treatment 
    • Suggestions that can give us insight into whether there are drugs, that will be rational that we, during epidemics with COVID-19, switch to of other medicines, or temporarily discontinue in people with symptoms
    • Suggestions affecting the course of illness in many citizens/patients, or with great severity in few.
    • Suggestions that can clarify doubts about the evidence. What has been revealed so far and on what basis?
    • Suggestions that can help provide evidence to make difficult drug-related choices
    • Suggestions that can help provide insight into, and improve advice on, who is at risk and which risk factors can be affected

Does the suggestion relate to any of the analysis on the Cochrane rapid reviews list?

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