NCT04438993

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

June 18, 2020

Last Update Submit

April 13, 2022

Conditions

Keywords

EchocardiogramTroponinNT-proBNPCytokines

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

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

Study Sites (1)

University Hospital Hairmyres

Glasgow, Scotland, G75 8RG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood plasma retained for future analysis.

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Robin A Weir, MD

    NHS Lanarkshire

    PRINCIPAL INVESTIGATOR

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

Locations