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
1 other identifier
observational
100
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2020
CompletedFirst Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2021
CompletedApril 21, 2022
April 1, 2022
8 months
June 18, 2020
April 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Biomarker - hsTnT
30 days
Biomarker - NT-proBNP
30 days
Biomarker - ferritin
30 days
Biomarker - cytokines
30 days
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- Refusal of consent for enrolment.
- Known pre-existing left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) \<40%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Lanarkshirelead
Study Sites (1)
University Hospital Hairmyres
Glasgow, Scotland, G75 8RG, United Kingdom
Biospecimen
Venous blood plasma retained for future analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin A Weir, MD
NHS Lanarkshire
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 19, 2020
Study Start
May 29, 2020
Primary Completion
January 29, 2021
Study Completion
January 29, 2021
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share