COVIDCOVICARENCT04438993
The COVID-19 Disease and CARdiac Events Study
An observational study of COVID and Coronavirus, run by NHS Lanarkshire at 1 site in United Kingdom.
Trial summary
An observational study of consecutive patients testing positive for COVID-19 who require admission to hospital to determine the degree of myocardial injury through biomarkers and echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and CARdiac Events study (COVICARE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Coronavirus
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 May 2020to 29 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: We plan to enrol all consecutive admissions with COVID-19 disease admitted to UHH up until a maximal target of 100 patients have been recruited. Patients will have a positive real time reverse transcription (rt)PCR for SARS-CoV-2 nasopharyngeal swab and/or chest X-ray or CT imaging showing classical COVID-19 disease abnormalities ('classic/probable COVID-19, mild/mod or severe' according to current British Society of Thoracic Imaging guidance, and be within 5 days of admission (so as to enable us to retrospectively add on biomarkers to blood samples sent on admission to hospital).
Who may be able to join
- Age ≥ 18 years
- In-patient in UHH within first 5 days of admission
- COVID-19 disease confirmed on rtPCR detection of SARS-CoV-2 from nasopharyngeal swabs and/or thoracic X-ray imaging findings characteristic of COVID-19 disease (positive swab results preferred).
- Able to provide written, informed consent.
Who cannot join
- Refusal of consent for enrolment.
- Known pre-existing left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) <40%.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Hairmyres
Glasgow, Scotland, G75 8RG
About this study
Official title: An Observational Study of Hospitalised Patients With Coronavirus Disease 2019 (COVID-19) to Determine the Degree of Myocardial Injury Using Biomarkers and Echocardiography, and the Impact of This on Cardiovascular Outcomes
An observational study of consecutive patients testing positive for COVID-19 who require admission to hospital to determine the degree of myocardial injury through biomarkers and echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and CARdiac Events study (COVICARE).
Read the detailed description
Purposes:
- To determine the prevalence of myocardial injury/impairment in patients hospitalised with COVID-19 disease.
- To determine the predictive value of baseline biomarkers in identifying patients at high risk of significant morbidity/mortality due to COVID-19.
Justification:
The Novel Coronavirus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), first recorded in Hubei Province of Wuhan China in December 2019 has now swept the globe and has been declared a pandemic by the World Health Organisation.
The largest published registry from the Chinese centre for disease control and prevention (CDC) describes a disease with a broad range of acuity but found from a cohort of 72314 confirmed or suspected cases (72314) 14% of those affected required hospitalisation and 5% required critical care. Thus far treatment has focused on quarantine and supportive care.
Predicting outcomes in COVID disease requires risk stratifying infected patients. Data so far have mainly come from small studies in China but the consistent risk factors appear to be advanced age, diabetes, hypertension and cardiovascular disease. The CDC report a 10.5% risk of death associated with underlying cardiovascular disease, surprisingly more than those with respiratory disease, especially given that lung involvement is the dominant clinical presentation. The reason for poor outcome in cardiovascular disease is unknown but is likely to be multifactorial. A literature search of nine observational studies reported myocardial injury based on high sensitivity troponin, abnormal ECG, abnormal echocardiogram or a combination of the three. The reported rate of myocardial injury ranged from 7-28% and in all groups was associated with higher rates of requirement for critical care. Mortality was increased compared to those without myocardial injury- 51.2% vs 4.5%.
Trial overview:
Patients admitted to University Hospital Hairmyres (UHH) with confirmed COVID-19 will have 3 biomarkers - high sensitivity troponin T (hsTnT), N-terminal (NT)-proBNP and ferritin - added on retrospectively to their admission blood samples, and an additional sample will be taken for cytokine analysis.
An ECG and echocardiogram will be performed.
Patients will be observed during the remainder of the hospitalisation and for up to 30 days from admission for major adverse cardiac events.
Statistical analysis:
The prevalence of echocardiographic abnormalities in the cohort will be presented.
Biomarker levels will be compared between patients who require intensive treatment unit (ITU) admission or not, ventilation or not or who die or survive up to 30 days using independent samples t-tests if the data are normally distributed or Mann-Whitney-U tests if non normally distributed.
- Conditions
- COVID, Coronavirus
- Keywords
- Echocardiogram, Troponin, NT-proBNP, Cytokines
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac abnormalities in COVID-19 disease in-patients
The primary objective of this study is to characterise the prevalence of myocardial injury and cardiac dysfunction in patients hospitalised with COVID-19 disease.
Measured: 6 months
Secondary outcomes (4)
Biomarker - hsTnT
To compare levels of hsTnT in ng/L between patients who experience an adverse event and those who do not.
Measured: 30 days
Biomarker - NT-proBNP
To compare levels of NT-proBNP in pg/ml between patients who experience an adverse event and those who do not.
Measured: 30 days
Biomarker - ferritin
To compare levels of ferritin in ug/L between patients who experience an adverse event and those who do not.
Measured: 30 days
Biomarker - cytokines
To compare levels of cytokines in pg/mL between patients who experience an adverse event and those who do not.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start29 May 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lanarkshire
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robin A Weir, MD, Principal investigator, NHS Lanarkshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438993
- Sponsor's protocol ID
- COVI-RW-2020
- Acronym
- COVICARE
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Hospitalised Patients With Coronavirus Disease 2019 (COVID-19) to Determine the Degree of Myocardial Injury Using Biomarkers and Echocardiography, and the Impact of This on Cardiovascular Outcomes
- ClinicalTrials.gov ID
- NCT04438993
- Acronym / sponsor ID
- COVICARE / COVI-RW-2020
- Conditions
- COVID, Coronavirus
- Keywords
- Echocardiogram, Troponin, NT-proBNP, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NHS LanarkshireOther government
- Study start
- 29 May 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 19 Jun 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.
An observational study of consecutive patients testing positive for COVID-19 who require admission to hospital to determine the degree of myocardial injury through biomarkers and echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and CARdiac Events study (COVICARE).
Detailed description
Purposes:
- To determine the prevalence of myocardial injury/impairment in patients hospitalised with COVID-19 disease.
- To determine the predictive value of baseline biomarkers in identifying patients at high risk of significant morbidity/mortality due to COVID-19.
Justification:
The Novel Coronavirus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), first recorded in Hubei Province of Wuhan China in December 2019 has now swept the globe and has been declared a pandemic by the World Health Organisation.
The largest published registry from the Chinese centre for disease control and prevention (CDC) describes a disease with a broad range of acuity but found from a cohort of 72314 confirmed or suspected cases (72314) 14% of those affected required hospitalisation and 5% required critical care. Thus far treatment has focused on quarantine and supportive care.
Predicting outcomes in COVID disease requires risk stratifying infected patients. Data so far have mainly come from small studies in China but the consistent risk factors appear to be advanced age, diabetes, hypertension and cardiovascular disease. The CDC report a 10.5% risk of death associated with underlying cardiovascular disease, surprisingly more than those with respiratory disease, especially given that lung involvement is the dominant clinical presentation. The reason for poor outcome in cardiovascular disease is unknown but is likely to be multifactorial. A literature search of nine observational studies reported myocardial injury based on high sensitivity troponin, abnormal ECG, abnormal echocardiogram or a combination of the three. The reported rate of myocardial injury ranged from 7-28% and in all groups was associated with higher rates of requirement for critical care. Mortality was increased compared to those without myocardial injury- 51.2% vs 4.5%.
Trial overview:
Patients admitted to University Hospital Hairmyres (UHH) with confirmed COVID-19 will have 3 biomarkers - high sensitivity troponin T (hsTnT), N-terminal (NT)-proBNP and ferritin - added on retrospectively to their admission blood samples, and an additional sample will be taken for cytokine analysis.
An ECG and echocardiogram will be performed.
Patients will be observed during the remainder of the hospitalisation and for up to 30 days from admission for major adverse cardiac events.
Statistical analysis:
The prevalence of echocardiographic abnormalities in the cohort will be presented.
Biomarker levels will be compared between patients who require intensive treatment unit (ITU) admission or not, ventilation or not or who die or survive up to 30 days using independent samples t-tests if the data are normally distributed or Mann-Whitney-U tests if non normally distributed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to enrol all consecutive admissions with COVID-19 disease admitted to UHH up until a maximal target of 100 patients have been recruited. Patients will have a positive real time reverse transcription (rt)PCR for SARS-CoV-2 nasopharyngeal swab and/or chest X-ray or CT imaging showing classical COVID-19 disease abnormalities ('classic/probable COVID-19, mild/mod or severe' according to current British Society of Thoracic Imaging guidance, and be within 5 days of admission (so as to enable us to retrospectively add on biomarkers to blood samples sent on admission to hospital).
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- In-patient in UHH within first 5 days of admission
- COVID-19 disease confirmed on rtPCR detection of SARS-CoV-2 from nasopharyngeal swabs and/or thoracic X-ray imaging findings characteristic of COVID-19 disease (positive swab results preferred).
- Able to provide written, informed consent.
Key exclusion criteria (2 listed)
- Refusal of consent for enrolment.
- Known pre-existing left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) <40%.
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
Cardiac abnormalities in COVID-19 disease in-patients
Time frame: 6 months
The primary objective of this study is to characterise the prevalence of myocardial injury and cardiac dysfunction in patients hospitalised with COVID-19 disease.
4 secondary outcomes
Biomarker - hsTnT
Time frame: 30 days
Biomarker - NT-proBNP
Time frame: 30 days
Biomarker - ferritin
Time frame: 30 days
Biomarker - cytokines
Time frame: 30 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 21 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Robin A Weir, MD principal investigator
NHS Lanarkshire
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 Coronavirus, run by NHS Lanarkshire at 1 site in United Kingdom.
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 4 inclusion and 2 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 21 Apr 2022. 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 United Kingdom. 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?
Cardiac abnormalities in COVID-19 disease in-patients (time frame: 6 months). 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 21 Apr 2022.