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

Hypertension Clinical Trial

— COR-CARDIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374110
• Other study ID #: 1860/2020
• Status: Recruiting
• Start date: May 5, 2020
• Est. completion date: August 24, 2021

Study information

• Verified date: May 2020
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Aleksander Prejbisz, MD, PhD
• Phone: +48223434339
• Email: aprejbisz[@]ikard.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 24, 2021
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients with COVID-19

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• COVID
• Hypertension

Intervention

Other:
• Clinical data
Clinical characteristics from medical records

Locations

Country	Name	City	State
Poland	National Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke	through study completion, an average of 2 weeks
Secondary	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
Secondary	Ventilation during hospitalization	Ventilation during hospitalization	through study completion, an average of 2 weeks
Secondary	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