Contrast Enhanced Ultrasound in COVID-19

NCT04640038 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20-017501
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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. The investigators plan to enroll and evaluate 30 patients.

Conditions

Covid19; Multisystem Inflammatory Syndrome in Children (MIS-C)

Keywords

Ultrasound; Contrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain

  Assess microvascular perfusion of the heart, kidneys and/or brain using CEUS in patients with confirmed or probable diagnosis of COVID-19. A sufficient diagnostic quality to analyze the ultrasound examination was accomplished in three out of four patients.

  15 minutes.

Study Arms (1)

Contrast-enhanced Ultrasonography

EXPERIMENTAL

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

Interventions

Sulfur hexafluoride lipid-type A microspheres DRUG

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.

Contrast-enhanced Ultrasonography

Eligibility Criteria

• Age: 1 Minute - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient (male/female) hospitalized at the Children's Hospital of Philadelphia (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 European Centre for Disease Prevention and Control).
• Patients have evidence of cardiovascular compromise, myocardial injury, acute kidney injury and/or new-onset neurological symptoms.
• Parental/guardian permission (informed consent)

You may not qualify if:

• \. Medical history of Lumason hypersensitivity

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (30)

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Related Links

• Latest updates on COVID-19 from the European Centre for Disease Prevention and Control
• Diagnosis of Acute Respiratory Syndrome Coronavirus 2 Infection by Detection of Nucleocapsid Protein

MeSH Terms

Conditions

COVID-19; pediatric multisystem inflammatory disease, COVID-19 related

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

Limitations and Caveats

Since this is an exploratory study with limited sample size, no absolute conclusions related to true microvascular impairment in MIS-C can be drawn. Whether heterogeneous results are due to the small sample, the timing of CEUS with regard to disease evolution and treatment, the use of concomitant medications, such as furosemide, a milder course of the disease, or the differing pathophysiology between MIS-C and primary COVID-19 infection in adults requires additional exploration.

Results Point of Contact

• Title: Misun Hwang
• Organization: Children's Hospital of Philadelphia

hwangm@chop.edu

267-425-7129

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 23, 2020
• Study Start: December 18, 2020
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: July 30, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)