Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19 (COR-CARDIO)
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ClinicalTrials.gov Identifier: NCT04374110 |
Recruitment Status :
Recruiting
First Posted : May 5, 2020
Last Update Posted : May 6, 2020
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Condition or disease | Intervention/treatment |
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COVID Hypertension Cardiovascular Diseases Cardiovascular Risk Factor | Other: Clinical data |
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.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1000 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | Prospective Monitoring of Drug Safety and the Occurrence of Complications During Hospitalization in Patients With Cardiovascular Diseases With COVID-19 |
Actual Study Start Date : | May 5, 2020 |
Estimated Primary Completion Date : | June 24, 2020 |
Estimated Study Completion Date : | August 24, 2021 |

Group/Cohort | Intervention/treatment |
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Hospitalized patients with COVID-19
Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
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Other: Clinical data
Clinical characteristics from medical records |
Infected SARS-CoV-2 patients
patients with SARS-CoV-2 infection not requiring hospitalization
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Other: Clinical data
Clinical characteristics from medical records |
Controls
structure-matched and co-existing disease matched control group from the general population.
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Other: Clinical data
Clinical characteristics from medical records |
- Adverse events [ Time Frame: through study completion, an average of 2 weeks ]Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
- Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke [ Time Frame: through study completion, an average of 2 weeks ]Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints
- Ventilation during hospitalization [ Time Frame: through study completion, an average of 2 weeks ]Ventilation during hospitalization
- Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke [ Time Frame: prolonged follow up, through study completion, an average of one year ]Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Hospitalized patients with COVID-19
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374110
Contact: Aleksander Prejbisz, MD, PhD | +48223434339 | aprejbisz@ikard.pl | |
Contact: Piotr Dobrowolski, MD, PhD | +48223434339 | pdobrowolski@ikard.pl |
Poland | |
National Institute of Cardiology | Recruiting |
Warsaw, Poland | |
Contact: Piotr Dobrowolski pdobrowolski@ikard.pl | |
Contact: Alekander Prejbisz aprejbisz@ikard.pl |
Principal Investigator: | Andrzej Januszewicz, MD, PhD | National Institute of Cardiology | |
Principal Investigator: | Tomasz Hryniewiecki, MD, PhD | National Institute of Cardiology | |
Principal Investigator: | Rafal Dabrowski, MD, PhD | National Institute of Cardiology |
Responsible Party: | Institute of Cardiology, Warsaw, Poland |
ClinicalTrials.gov Identifier: | NCT04374110 |
Other Study ID Numbers: |
1860/2020 |
First Posted: | May 5, 2020 Key Record Dates |
Last Update Posted: | May 6, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Angiotensin converting enzyme inhibitors Angiotensin 2 receptor blockers Renin angiotensin system COVID-19 Hypertension |
Hypertension Cardiovascular Diseases Vascular Diseases |