The prognosis of coronavirus disease (COVID-19) in patients recently treated with immunosuppressant medications.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41572
• EU PAS number:
  EUPAS36056
• Study ID:
  41572
• Official title and acronym:
  The prognosis of coronavirus disease (COVID-19) in patients recently treated with immunosuppressant medications.
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Immunosuppressant medications are effective treatments for several immune-mediated inflammatory diseases, as well as vasculitides, chronic lung diseases and certain malignancies. These medications have a strong effect on the immune system decreasing inflammation, but this has prompted concerns regarding the body’s defence against infection. This is particularly pertinent during the current epidemic of coronavirus (COVID-19), as a weakened immune system may be vulnerable to severe coronavirus disease. We aim to evaluate the prognosis of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection in patients treated with immunomodulating medications, including immunosuppressants and systemic glucocorticoids. We will leverage unique Danish health registers to conduct a nationwide cohort study of the outcome of SARS-COV-2 infection, i.e. admission to hospital, admission to intensive care unit (intensive care observation/intensive care therapy) or death, in this patient population, with adjustment for the severity of patients’ underlying indication for immunosuppression, as well as other factors that may affect the course of coronavirus disease.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Southern Denmark (SDU)

Denmark

Study timelines

Date when funding contract was signed

Planned: 27/02/2020

Actual: 27/02/2020

Study start date

Planned: 27/02/2020

Actual: 27/02/2020

Data analysis start date

Planned: 30/06/2020

Date of final study report

Planned: 30/07/2020

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Lundbeck Foundation, University of Southern Denmark

Study protocol

Initial protocol

EUPAS protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable