Evaluate Long Term Cardiovascular and Pulmonary Complications After COVID-19 With Point of Care Ultrasound

NCT04756193 | Completed

• 1 other identifier: 20.0836
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that recovered COVID-19 patients suffer long term cardiovascular and pulmonary complications, which can be detected by point of care ultrasound. The goal is to comprehensively delineate the long term cardiovascular and pulmonary ultrasound findings in recovered COVID-19 patients, identify risks factors for prolonged heart/lung injury, evaluate long term effects of applied treatment, and assess late medication/vaccine side effects in COVID-19 patients.

Conditions

Covid19; Echocardiography; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Echocardiographic strain measurements of the left, right heart

  strain is a measurement of systolic function of the heart, unit is %. The more negative means better outcome

  Up to 12 months

Secondary Outcomes (1)

• Lung ultrasound measurements

  Up to 12 months

Other Outcomes (1)

• Vascular ultrasound findings

  Up to 12 months

Study Arms (5)

Asymptomatic/Mild COVID-19 Group

50 confirmed COVID-19 patients who showed no or only mild respiratory/GI symptoms (not admitted to the hospital at all)

Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound

Moderate COVID-19 Group

50 confirmed COVID-19 patients who were able to maintain oxygen saturation above 92% (or above 90% for patients with chronic lung disease) with up to 4 L/min oxygen via nasal prongs (admitted to the hospital, but never to the ICU and no obvious cardiac complications during the stay)

Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound

Severe COVID-19 Group

50 confirmed COVID-19 patients who had oxygen saturation lower than 92% at rest and PaO2/FiO2 between 200 and 300 (High-flow oxygen group, mostly in the ICU, and may have some cardiac complications)

Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound

Critical COVID-19 Group

50 confirmed COVID-19 patients who had PaO2/FiO2 less than 200 or required mechanical ventilation (in the ICU, need mechanical ventilation and more likely to have cardiac complications)

Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound

Control Group

50 age and sex-matched controls from our hospital admission database

Diagnostic Test: Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound

Interventions

Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound DIAGNOSTIC_TEST

Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry

Also known as: ECG, pulse oximetry, blood draw, spirometry

Asymptomatic/Mild COVID-19 Group; Control Group; Critical COVID-19 Group; Moderate COVID-19 Group; Severe COVID-19 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic/Mild Group: 50 confirmed COVID-19 patients who showed no or only mild respiratory/GI symptoms; Moderate Group: 50 confirmed COVID-19 patients who were able to maintain oxygen saturation above 92% (or above 90% for patients with chronic lung disease) with up to 4 L/min oxygen via nasal prongs; Severe Group: 50 confirmed COVID-19 patients who had oxygen saturation less than 92% at rest and PaO2/FiO2 between 200 and 300; Critical Group: 50 confirmed COVID-19 patients who had PaO2/FiO2 less than 200 or required mechanical ventilation. Control Group: 50 age and sex-matched controls.

You may qualify if:

• \>18 years of age
• Consent to participate in this research
• Confirmed SARS-CoV-2 infection by RT-PCR or serological tests.

You may not qualify if:

• Refusal to participate in this research

Sponsors & Collaborators

• University of Louisville: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Louisville Health

Louisville, Kentucky, 40202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

COVID-19

Interventions

Electrocardiography; Oximetry; Blood Specimen Collection; Spirometry

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Jiapeng Huang, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 16, 2021
• Study Start: April 15, 2021
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)