The COVID-19 Disease and CARdiac Events Study

COVID Clinical Trial

— COVICARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04438993
• Other study ID #: COVI-RW-2020
• Status: Completed
• Start date: May 29, 2020
• Est. completion date: January 29, 2021

Study information

• Verified date: April 2022
• Source: NHS Lanarkshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Description:

Purposes:

1. To determine the prevalence of myocardial injury/impairment in patients hospitalised with COVID-19 disease.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. In-patient in UHH within first 5 days of admission

3. 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).

4. Able to provide written, informed consent.

Exclusion Criteria:

1. Refusal of consent for enrolment.

2. Known pre-existing left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) <40%.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID

Locations

Country	Name	City	State
United Kingdom	University Hospital Hairmyres	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lanarkshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Biomarker - hsTnT	To compare levels of hsTnT in ng/L between patients who experience an adverse event and those who do not.	30 days
Secondary	Biomarker - NT-proBNP	To compare levels of NT-proBNP in pg/ml between patients who experience an adverse event and those who do not.	30 days
Secondary	Biomarker - ferritin	To compare levels of ferritin in ug/L between patients who experience an adverse event and those who do not.	30 days
Secondary	Biomarker - cytokines	To compare levels of cytokines in pg/mL between patients who experience an adverse event and those who do not.	30 days