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Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19 (COR-CARDIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374110
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, 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.

Condition or disease Intervention/treatment
COVID Hypertension Cardiovascular Diseases Cardiovascular Risk Factor Other: Clinical data

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.

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hospitalized patients with COVID-19
Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
Other: Clinical data
Clinical characteristics from medical records

Infected SARS-CoV-2 patients
patients with SARS-CoV-2 infection not requiring hospitalization
Other: Clinical data
Clinical characteristics from medical records

Controls
structure-matched and co-existing disease matched control group from the general population.
Other: Clinical data
Clinical characteristics from medical records




Primary Outcome Measures :
  1. Adverse events [ Time Frame: through study completion, an average of 2 weeks ]
    Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke


Secondary Outcome Measures :
  1. 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

  2. Ventilation during hospitalization [ Time Frame: through study completion, an average of 2 weeks ]
    Ventilation during hospitalization

  3. 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



Information from the National Library of Medicine

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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
Study Population
Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
Criteria

Inclusion Criteria:

  • Hospitalized patients with COVID-19

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Aleksander Prejbisz, MD, PhD +48223434339 aprejbisz@ikard.pl
Contact: Piotr Dobrowolski, MD, PhD +48223434339 pdobrowolski@ikard.pl

Locations
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Poland
National Institute of Cardiology Recruiting
Warsaw, Poland
Contact: Piotr Dobrowolski       pdobrowolski@ikard.pl   
Contact: Alekander Prejbisz       aprejbisz@ikard.pl   
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
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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
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Cardiology, Warsaw, Poland:
Angiotensin converting enzyme inhibitors
Angiotensin 2 receptor blockers
Renin angiotensin system
COVID-19
Hypertension
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases