COVIDCOR-CARDIONCT04374110
Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19
An observational study of COVID and Hypertension, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Hypertension, Cardiovascular Diseases
- What is being tested?
- Clinical data
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 5 May 2020to 24 Aug 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
Who may be able to join
- Hospitalized patients with COVID-19
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
National Institute of Cardiology
Warsaw
Piotr Dobrowolski, pdobrowolski@ikard.pl
Alekander Prejbisz, aprejbisz@ikard.pl
About this study
Official title: Prospective Monitoring of Drug Safety and the Occurrence of Complications During Hospitalization in Patients With Cardiovascular Diseases With COVID-19
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.
Read the 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.
- Being tested
- Clinical data
- Keywords
- Angiotensin converting enzyme inhibitors, Angiotensin 2 receptor blockers, Renin angiotensin system, COVID-19, Hypertension
- Medical subject headings
- Hypertension, Cardiovascular Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical dataOther
Clinical characteristics from medical records
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients with COVID-19 | Hospitalized patients with COVID-19 will be included in the study in centers around Poland. Receives: Other: Clinical data | |
| Infected SARS-CoV-2 patients | patients with SARS-CoV-2 infection not requiring hospitalization Receives: Other: Clinical data | |
| Controls | structure-matched and co-existing disease matched control group from the general population. Receives: Other: Clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
Measured: through study completion, an average of 2 weeks
Secondary outcomes (3)
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
Measured: through study completion, an average of 2 weeks
Ventilation during hospitalization
Ventilation during hospitalization
Measured: 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
Measured: prolonged follow up, through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start5 May 2020
- Primary completion24 Jun 2020 (estimated)
- Study completion24 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrzej Januszewicz, MD, PhD, Principal investigator, National Institute of CardiologyTomasz Hryniewiecki, MD, PhD, Principal investigator, National Institute of CardiologyRafal Dabrowski, MD, PhD, Principal investigator, National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374110
- Sponsor's protocol ID
- 1860/2020
- Acronym
- COR-CARDIO
- Status last verified
- May 2020
- First submitted
- 22 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monitoring of Drug Safety and the Occurrence of Complications During Hospitalization in Patients With Cardiovascular Diseases With COVID-19
- ClinicalTrials.gov ID
- NCT04374110
- Acronym / sponsor ID
- COR-CARDIO / 1860/2020
- Keywords
- Angiotensin converting enzyme inhibitors, Angiotensin 2 receptor blockers, Renin angiotensin system, COVID-19, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 24 Jun 2020 (estimated)
- Study completion
- 24 Aug 2021 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients with COVID-19 | – | Other: Clinical dataHospitalized patients with COVID-19 will be included in the study in centers around Poland. |
| Infected SARS-CoV-2 patients | – | Other: Clinical datapatients with SARS-CoV-2 infection not requiring hospitalization |
| Controls | – | Other: Clinical datastructure-matched and co-existing disease matched control group from the general population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
Key inclusion criteria (1 listed)
- Hospitalized patients with COVID-19
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical dataClinical characteristics from medical records | Other | Controls, Hospitalized patients with COVID-19, Infected SARS-CoV-2 patients |
Primary outcome
Adverse events
Time frame: through study completion, an average of 2 weeks
Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
3 secondary outcomes
Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
Time frame: through study completion, an average of 2 weeks
Ventilation during hospitalization
Time frame: through study completion, an average of 2 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Januszewicz, MD, PhD principal investigator
National Institute of Cardiology
Tomasz Hryniewiecki, MD, PhD principal investigator
National Institute of Cardiology
Rafal Dabrowski, MD, PhD principal investigator
National Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Hypertension, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksander Prejbisz, MD, PhD (+48223434339, aprejbisz@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: through study completion, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.