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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04374110
Acronym
COR-CARDIO
Enrollment
1000
Registered
2020-05-05
Start date
2020-05-05
Completion date
2021-08-24
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Risk Factor, COVID, Hypertension

Keywords

Angiotensin converting enzyme inhibitors, Angiotensin 2 receptor blockers, Renin angiotensin system, COVID-19, Hypertension

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.

Interventions

Clinical characteristics from medical records

Sponsors

National Institute of Cardiology, Warsaw, Poland
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospitalized patients with COVID-19

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsthrough study completion, an average of 2 weeksDeath, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Secondary

MeasureTime frameDescription
Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, strokethrough study completion, an average of 2 weeksNumber of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints
Ventilation during hospitalizationthrough study completion, an average of 2 weeksVentilation during hospitalization

Countries

Poland

Contacts

Primary ContactAleksander Prejbisz, MD, PhD
aprejbisz@ikard.pl+48223434339
Backup ContactPiotr Dobrowolski, MD, PhD
pdobrowolski@ikard.pl+48223434339

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026