COVID-19JOCOVIDNCT04320017
Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observational Study to Monitor Cardio-vascular Events and Predict Outcomes in Patients Diagnosed With COVID-19
An observational study of COVID-19 and Myocardial Injury, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
COVID-19 outbreak is often lethal. Mortality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Other clinico-biological features predictive of mortality or transfer to Intensive Care Unit are also needed. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19, Myocardial Injury, Myocarditis
- What is being tested?
- Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2020to 20 Jul 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted in Pitié-Salpêtrière hospital will be eligible, if the electrocardiogram and the transthoracic echocardiography is technically feasible.
Who may be able to join
- COVID-19 positive patients admitted in a ward identified by positive PCR on nasal swab samples
Who cannot join
- Patients who refused the use of their routine care data after information by investigators.
Trial locations and contacts
1 site in 1 country.
About this study
COVID-19 outbreak is often lethal. Mortality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Other clinico-biological features predictive of mortality or transfer to Intensive Care Unit are also needed. Cases of myocarditis have also been reported with COVID-19.
Cardio-vascular events have possibly been highly underestimated. The study proposes to systematically collect cardio-vascular data to study the incidence of myocarditis and coronaropathy events during COVID-19 infection.We will also assess predictive factors for transfer in Intensive Care Unit or death.
- Conditions
- COVID-19, Myocardial Injury, Myocarditis
- Being tested
- Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care
- Keywords
- Coronavirus, Heart conditions, Cardio-vascular outcomes
- Medical subject headings
- COVID-19, Myocarditis, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine careDiagnostic test
- 12 derivations electrocardiogram done at baseline and repeated every 3 days
- transthoracic echocardiography at baseline
- clinical features at baseline: WHO performans status comorbidities and treatments
- biological results in routine care, such as baseline full blood count, inflammation markers: C-reactive protein, procalcitonin, interleukin-6 and ferritin, coagulation and troponin and brain natriuretic peptide
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Patients diagnosed with COVID-19 by PCR done on nasal sample. Receives: Diagnostic Test: Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay
Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography
Measured: ECG and concomitant troponine at day 1 after admission at day 1, day 3 day 6 the first week after admission, and then at day 14 and before the patient is discharged (up to 20 days)
Secondary outcomes (5)
Description of cardiovascular outcomes in the cohort
Cardio-vascular events including but not limited to: myocardial infarction or stenosis, stroke, pulmonary embolism, deep vein thrombosis, ventricular dysfunctio, conduction disorders and sudden death
Measured: During hospital admission (up to 20 days)
Prognosis role of baseline cardio-vascular caracteristics on patients survival
Biological biomarkers including but not limited to: baseline troponine T, D-dimers, NT-proBNP, creatinine phosphokinase, creatininemia, ionogram, renine-angiotensin aldosterone system profiling, glycemia (fasting), HbA1c, steroid profiling, lipid profiling
Measured: 1st day of admission
Prediction of cardio-vascular events with baseline characteristics
Measured: Baseline on first day of admission
Characterization of inflammation on cardio-vascular outcomes
Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6
Measured: Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)
Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival
clinical features at baseline: WHO performans status comorbidities and treatments Biological markers including but not limited to: full blood count, C reactive protein, procalcitonine, fibrinogen, interleukin-6, troponin and brain natriuretic peptide
Measured: Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start20 Mar 2020
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320017
- Sponsor's protocol ID
- CIC1421-20-05
- Acronym
- JOCOVID
- Status last verified
- Jan 2023
- First submitted
- 20 Mar 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fenioux C, Allenbach Y, Vozy A, Salem JE, Maalouf G, Vieira M, Le Joncour A, Benveniste O, Saadoun D, Frere C, Campedel L, Salem P, Gligorov J, Funck-Brentano C, Cacoub P, Gougis P. [Differences of characteristics and outcomes between cancer patients and patients with no active cancer hospitalised for a SARS-CoV-2 infection]. Bull Cancer. 2021 Jun;108(6):581-588. doi: 10.1016/j.bulcan.2021.03.004. Epub 2021 Mar 20. French.
PubMed 33966886
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observational Study to Monitor Cardio-vascular Events and Predict Outcomes in Patients Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT04320017
- Acronym / sponsor ID
- JOCOVID / CIC1421-20-05
- Conditions
- COVID-19, Myocardial Injury, Myocarditis
- Keywords
- Coronavirus, Heart conditions, Cardio-vascular outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 24 Mar 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.
COVID-19 outbreak is often lethal. Mortality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Other clinico-biological features predictive of mortality or transfer to Intensive Care Unit are also needed. Cases of myocarditis have also been reported with COVID-19.
Cardio-vascular events have possibly been highly underestimated. The study proposes to systematically collect cardio-vascular data to study the incidence of myocarditis and coronaropathy events during COVID-19 infection.We will also assess predictive factors for transfer in Intensive Care Unit or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Diagnostic Test: Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine carePatients diagnosed with COVID-19 by PCR done on nasal sample. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted in Pitié-Salpêtrière hospital will be eligible, if the electrocardiogram and the transthoracic echocardiography is technically feasible.
Key inclusion criteria (1 listed)
- COVID-19 positive patients admitted in a ward identified by positive PCR on nasal swab samples
Key exclusion criteria (1 listed)
- Patients who refused the use of their routine care data after information by investigators.
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 |
|---|---|---|
| Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care* 12 derivations electrocardiogram done at baseline and repeated every 3 days * transthoracic echocardiography at baseline * clinical features at baseline: WHO performans status comorbidities and treatments * biological results in routine care, such as baseline full blood count, inflammation markers: C-reactive protein, procalcitonin, interleukin-6 and ferritin, coagulation and troponin and brain natriuretic peptide | Diagnostic test | COVID-19 patients |
Primary outcome
Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay
Time frame: ECG and concomitant troponine at day 1 after admission at day 1, day 3 day 6 the first week after admission, and then at day 14 and before the patient is discharged (up to 20 days)
Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography
5 secondary outcomes
Description of cardiovascular outcomes in the cohort
Time frame: During hospital admission (up to 20 days)
Prognosis role of baseline cardio-vascular caracteristics on patients survival
Time frame: 1st day of admission
Prediction of cardio-vascular events with baseline characteristics
Time frame: Baseline on first day of admission
Characterization of inflammation on cardio-vascular outcomes
Time frame: Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)
Prognosis role of baseline clinico-biological caracteristics on patients transfer to ICU and survival
Time frame: Baseline and at day 3 day 6 day 14 and before patient is discharged (up to 20 days)
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 4 Jan 2023.
- Derived from this study: PubMed 33966886Fenioux C, Allenbach Y, Vozy A, Salem JE, Maalouf G, Vieira M, Le Joncour A, Benveniste O, Saadoun D, Frere C, Campedel L, Salem P, Gligorov J, Funck-Brentano C, Cacoub P, Gougis P. [Differences of characteristics and outcomes between cancer patients and patients with no active cancer hospitalised for a SARS-CoV-2 infection]. Bull Cancer. 2021 Jun;108(6):581-588. doi: 10.1016/j.bulcan.2021.03.004. Epub 2021 Mar 20. French.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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-19 and Myocardial Injury, run by Groupe Hospitalier Pitie-Salpetriere at 1 site 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 4 Jan 2023. 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 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?
Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay (time frame: ECG and concomitant troponine at day 1 after admission at day 1, day 3 day 6 the first week after admission, and then at day 14 and before the patient is discharged (up to 20 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 NCT04320017, which also lists 1 linked publication.
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 4 Jan 2023.