Clinical trial NCT04374110: Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19
Official title: Prospective Monitoring of Drug Safety and the Occurrence of Complications During Hospitalization in Patients With Cardiovascular Diseases With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Hypertension
Cardiovascular Diseases
Cardiovascular Risk Factor
Keywords: Angiotensin converting enzyme inhibitors
Angiotensin 2 receptor blockers
Renin angiotensin system
COVID-19
Hypertension
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with COVID-19 will be included in the study in centers around Poland.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with COVID-19

Exclusion Criteria:

* None

Primary outcomes:
measure: Adverse events
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
timeFrame: through study completion, an average of 2 weeks
measure: Ventilation during hospitalization
timeFrame: through study completion, an average of 2 weeks
measure: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
timeFrame: prolonged follow up, through study completion, an average of one year
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology
name: Andrzej Januszewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology
name: Tomasz Hryniewiecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology
name: Rafal Dabrowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: