The COVID-19 Disease and CARdiac Events Study (COVICARE)

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).

Study Overview

• Status: Completed
• Conditions: COVID; Coronavirus

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G75 8RG
      • University Hospital Hairmyres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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).

Description

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%.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker - hsTnT	To compare levels of hsTnT in ng/L between patients who experience an adverse event and those who do not.	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.	30 days
Biomarker - ferritin	To compare levels of ferritin in ug/L between patients who experience an adverse event and those who do not.	30 days
Biomarker - cytokines	To compare levels of cytokines in pg/mL between patients who experience an adverse event and those who do not.	30 days

Collaborators and Investigators

• Sponsor: NHS Lanarkshire
• Investigators: Principal Investigator: Robin A Weir, MD, NHS Lanarkshire

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Actual): January 29, 2021
• Study Completion (Actual): January 29, 2021

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cytokines; Echocardiogram; Troponin; NT-proBNP
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: COVI-RW-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No