Contrast Enhanced Ultrasound in COVID-19

Study Overview
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Brief Summary
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Initial data from COVID-19 patients suggests that one of the primary causes of death is significant endothelial injury leading to blood clotting and impaired multiorgan microvascular perfusion. The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to estimate the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients in vivo and assess the significance of imaging findings by correlating to clinical outcomes. This pilot study will be conducted at one site, The Children's Hospital of Philadelphia. We will enroll and evaluate 30 patients.

Detailed Description
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The current study uses a safe, convenient bedside imaging tool called contrast-enhanced ultrasound (CEUS) to measure the extent of microvascular perfusion impairment in the heart, kidneys and/or brain of COVID-19 pediatric patients and, as exploratory analysis, to assess the significance of imaging findings by correlating to clinical outcomes. Sulfur hexafluoride lipid-type A microspheres (LumasonTM, Bracco Inc) is an FDA-approved ultrasound contrast agent. Contrast-enhanced ultrasound scan with a duration of approximately 15 minutes will be performed when a COVID-19 diagnosis has been made (or is highly suspected) according to established clinical procedures. One CEUS will be performed per patient, with up to 2 intravenous injections of the contrast agent. The dosing plan will be weight-adjusted, based on a dose of 0.03 mL/kg (with a maximum dose of 2.4 mL per injection). Organ perfusion will be evaluated in the heart, kidneys, and/or brain. Clinical outcomes during hospital stay will be collected for correlation to CEUS-based measures.

Official Title
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Contrast Enhanced Ultrasound (CEUS) Detection of Microvascular Perfusion Impairment in COVID-19 Pediatric Patients

Conditions
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Covid19, MIS-C

Intervention / Treatment
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* Drug: Sulfur hexafluoride lipid-type A microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient (male/female) hospitalized at CHOP. Patient 17 years of age or younger. Diagnosis of COVID-19 or high clinical suspicion for COVID-19 despite negative tests (according to the definition of probable case by the ECDC). Patients have evidence of cardiovascular compromise, myocardial injury, acute kidney injury and/or new-onset neurological symptoms. Parental/guardian permission (informed consent) Exclusion Criteria: 1. Medical history of Lumason hypersensitivity

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast-enhanced Ultrasonography<br>Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing contrast-enhanced ultrasound (CEUS). In pediatric patients, after reconstitution 0.03 mL per kg is administered intravenously. The weight-based dose of 0.03 mL per kg will be repeated one time during a single examination. Following each injection, an intravenous flush of 0.9% Sodium Chloride is injected. The study duration per subject will be approximately 15 minutes including the time to prepare the contrast agent and perform the CEUS, as well as the 60 minute monitoring period after the first and second injection (if there are two injections of contrast) of the contrast agent. | Drug: Sulfur hexafluoride lipid-type A microspheres<br>* Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed to evaluate for dynamic bowel perfusion and several 2-minute cine clips as well as static images will be acquired during the exam.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the proportion of patients with normal perfusion versus area(s) of hypoperfusion in heart, kidneys and/or brain |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Contrast-enhanced ultrasound