Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19

SARS-Cov-2 infection is characterized by a varied clinical course, from asymptomatic to
severe respiratory failure in the course of pneumonia, which can be fatal. There are reports
in the literature regarding the relationship between the course of an acute respiratory
disease syndrome caused by SARS-CoV-2 virus infection (Coronavirus 2019, COVID-19) and the
history of cardiovascular diseases (CVD), including hypertension. It is postulated that the
shared element of the pathogenesis of CVD, hypertension and COVID-19 is the renin-angiotensin
system and one of its elements, the angiotensin converting enzyme 2 (ACE2). It has been
postulated by some authors that in the course of hypertension and antihypertensive treatment
with renin-angiotensin system inhibitors, there may be an upregulation of ACE2, which in turn
may be related to a higher risk of more severe course of COVID-19. On the other hand there is
also data the renin-angiotensin system inhibitors by increasing ACE2 concentration may be
protective in the course of severe pneumonia.

The study undertaken by the National Institute of Cardiology aims to assess the safety of the
cardiovascular drugs in relation to the occurrence of complications during hospitalization in
patients with CVD and COVID-19 infection. The study is being conducted by Polish-German
collaboration and was initiated by prof Reinhold Kreutz from Institute of Clinical
Pharmacology and Toxicology, Charite, Berlin, Germany and team from National Institute of
Cardiology lead by prof. Andrzej Januszewicz and prof. Tomasz Hryniewiecki, Director of the
National Institute of Cardiology.

Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
After the hospitalization, a short questionnaire will be completed, including
pre-hospitalization diagnoses, pre-hospitalization medications, clinical status on admission,
the course, complication and the duration of hospitalization. The questionnaire will be
available in paper form and on-line.

It will also be planned to include control groups from the official databases: 1) patients
with SARS-CoV-2 infection not requiring hospitalization, and 2) structure-matched and
co-existing disease matched control group from the general population.