COVIDCovCardioVascNCT04335162
Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)
An observational study of COVID and Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Nice at 8 sites in France.
Trial summary
Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Acute Coronary Syndrome, Myocardial Infarction
- How many people
- 198 participants
- Where
- 8 sitesFrance
- Study dates
- 28 Feb 2020to 31 Aug 2021
- 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
- Adult, Older adult
Study population: Intensive care unit, hospital ward
Who may be able to join
- All consecutive patients with COVID-19 infection admitted to the ICU or hospitalized because of severe form (eg: hypoxia, orthopnea, pneumonitis, kidney insufficiency) will be included
Who cannot join
- Patients under 18 years
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Hospitalier de Cannes
Cannes, 06400
CHU de Dijon
Dijon
Centre Hospitalier de Draguignan
Draguignan, 83300
Centre Hospitalier de Grasse
Grasse, 06130
Clinique Ambroise-Paré
Neuilly
CHU de Nice
Nice, 06200
Hôpitaux Universitaires Paris Centre - Hôpital Cochin
Paris, 75014
CHU de REIMS
Reims
About this study
Official title: Cardiovascular Complications in Patients With COVID-19
Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.
- Conditions
- COVID, Acute Coronary Syndrome, Myocardial Infarction, Myocarditis, Venous Thromboembolism, Deep Vein Thrombosis
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Myocarditis, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiovascular complications | Patients presenting with cardiomyopathies or venous thromboembolism | |
| Patients without cardiovascular complications | Patients without cardiomyopathies or venous thromboembolism | |
| Intensive Care Unit patients | Patients admitted in intensive care unit | |
| Hospital Ward patients | Patients admitted in hospital ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the incidence of cardiomyopathies and venous thromboembolism
Incidence of cardiomyopathies and/or venous thromboembolism at day 28
Measured: 28 days
Secondary outcomes (6)
Mortality
Incidence of mortality at day 28
Measured: 28 days
Duration of mechanical ventilation
Number of day of using mechanical ventilation for each patients
Measured: hospitalisation duration
Shock
Incidence of shock during hospitalisation
Measured: hospitalisation duration
length of stay
Number of day at hospital
Measured: hospitalisation duration
Mechanical ventilation
Setting up or not of mechanical ventilation
Measured: hospitalisation duration
Renal replacement therapy
Administration or not of renal replacement therapy
Measured: hospitalisation duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start28 Feb 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis DOYEN, Principal investigator, CHU de NICE - Archet 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335162
- Sponsor's protocol ID
- 20reamedcovid01
- Acronym
- CovCardioVasc
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2020
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing plan has been established.
Publications
Jozwiak M, Dupuis C, Denormandie P, Aurenche Mateu D, Louchet J, Heme N, Mira JP, Doyen D, Dellamonica J. Right ventricular injury in critically ill patients with COVID-19: a descriptive study with standardized echocardiographic follow-up. Ann Intensive Care. 2024 Jan 23;14(1):14. doi: 10.1186/s13613-024-01248-8.
PubMed 38261092Jozwiak M, Doyen D, Denormandie P, Goury A, Marey J, Pene F, Cariou A, Mira JP, Dellamonica J, Nguyen LS. Impact of sex differences on cardiac injury in critically ill patients with COVID-19. Respir Res. 2023 Nov 20;24(1):292. doi: 10.1186/s12931-023-02581-5.
PubMed 37986157Ferrari E, Sartre B, Squara F, Contenti J, Occelli C, Lemoel F, Levraut J, Doyen D, Dellamonica J, Mondain V, Chirio D, Risso K, Cua E, Orban JC, Ichai C, Labbaoui M, Mossaz B, Moceri P, Appert-Flory A, Fischer F, Toulon P. High Prevalence of Acquired Thrombophilia Without Prognosis Value in Patients With Coronavirus Disease 2019. J Am Heart Assoc. 2020 Nov 3;9(21):e017773. doi: 10.1161/JAHA.120.017773. Epub 2020 Sep 25.
PubMed 32972320
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Complications in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04335162
- Acronym / sponsor ID
- CovCardioVasc / 20reamedcovid01
- Conditions
- COVID, Acute Coronary Syndrome, Myocardial Infarction, Myocarditis, Venous Thromboembolism, Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Apr 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.
Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiovascular complications | – | –Patients presenting with cardiomyopathies or venous thromboembolism |
| Patients without cardiovascular complications | – | –Patients without cardiomyopathies or venous thromboembolism |
| Intensive Care Unit patients | – | –Patients admitted in intensive care unit |
| Hospital Ward patients | – | –Patients admitted in hospital ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit, hospital ward
Key inclusion criteria (1 listed)
- All consecutive patients with COVID-19 infection admitted to the ICU or hospitalized because of severe form (eg: hypoxia, orthopnea, pneumonitis, kidney insufficiency) will be included
Key exclusion criteria (1 listed)
- Patients under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the incidence of cardiomyopathies and venous thromboembolism
Time frame: 28 days
Incidence of cardiomyopathies and/or venous thromboembolism at day 28
6 secondary outcomes
Mortality
Time frame: 28 days
Duration of mechanical ventilation
Time frame: hospitalisation duration
Shock
Time frame: hospitalisation duration
length of stay
Time frame: hospitalisation duration
Mechanical ventilation
Time frame: hospitalisation duration
Renal replacement therapy
Time frame: hospitalisation duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 38261092Jozwiak M, Dupuis C, Denormandie P, Aurenche Mateu D, Louchet J, Heme N, Mira JP, Doyen D, Dellamonica J. Right ventricular injury in critically ill patients with COVID-19: a descriptive study with standardized echocardiographic follow-up. Ann Intensive Care. 2024 Jan 23;14(1):14. doi: 10.1186/s13613-024-01248-8.
- Derived from this study: PubMed 37986157Jozwiak M, Doyen D, Denormandie P, Goury A, Marey J, Pene F, Cariou A, Mira JP, Dellamonica J, Nguyen LS. Impact of sex differences on cardiac injury in critically ill patients with COVID-19. Respir Res. 2023 Nov 20;24(1):292. doi: 10.1186/s12931-023-02581-5.
- Derived from this study: PubMed 32972320Ferrari E, Sartre B, Squara F, Contenti J, Occelli C, Lemoel F, Levraut J, Doyen D, Dellamonica J, Mondain V, Chirio D, Risso K, Cua E, Orban JC, Ichai C, Labbaoui M, Mossaz B, Moceri P, Appert-Flory A, Fischer F, Toulon P. High Prevalence of Acquired Thrombophilia Without Prognosis Value in Patients With Coronavirus Disease 2019. J Am Heart Assoc. 2020 Nov 3;9(21):e017773. doi: 10.1161/JAHA.120.017773. Epub 2020 Sep 25.
- Individual participant dataSharing planned: No. no data sharing plan has been established.
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Denis DOYEN principal investigator
CHU de NICE - Archet 1
8 sites 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 Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Nice at 8 sites in France.
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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the incidence of cardiomyopathies and venous thromboembolism (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335162, which also lists 3 linked publications.
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 3 Apr 2025.