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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Monitoring of Drug Safety and the Occurrence of Complications During Hospitalization in Patients With Cardiovascular Diseases With COVID-19

Conditions
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COVID, Hypertension, Cardiovascular Diseases, Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Clinical data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients with COVID-19 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized patients with COVID-19<br>Hospitalized patients with COVID-19 will be included in the study in centers around Poland. | Other: Clinical data<br>* Clinical characteristics from medical records<br>|
| Infected SARS-CoV-2 patients<br>patients with SARS-CoV-2 infection not requiring hospitalization | Other: Clinical data<br>* Clinical characteristics from medical records<br>|
| Controls<br>structure-matched and co-existing disease matched control group from the general population. | Other: Clinical data<br>* Clinical characteristics from medical records<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke | through study completion, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke | Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints | through study completion, an average of 2 weeks | 
| Ventilation during hospitalization | Ventilation during hospitalization | through study completion, an average of 2 weeks | 
| Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke | Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints | prolonged follow up, through study completion, an average of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiotensin converting enzyme inhibitors, Angiotensin 2 receptor blockers, Renin angiotensin system, COVID-19, Hypertension