Contrast Enhanced Ultrasound in COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640038
• Other study ID #: 20-017501
• Status: Completed
• Phase: Phase 3
• Start date: December 18, 2020
• Est. completion date: September 17, 2021

Study information

• Verified date: March 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 17, 2021
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 17 Years

Eligibility

Inclusion Criteria:

1. Patient (male/female) hospitalized at the Children's Hospital of Philadelphia (CHOP).

2. Patient 17 years of age or younger.

3. 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).

4. Patients have evidence of cardiovascular compromise, myocardial injury, acute kidney injury and/or new-onset neurological symptoms.

5. Parental/guardian permission (informed consent)

Exclusion Criteria:

1. Medical history of Lumason hypersensitivity

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Multisystem Inflammatory Syndrome in Children (MIS-C)

Intervention

Drug:
• Sulfur hexafluoride lipid-type A microspheres
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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Diagnosis of Acute Respiratory Syndrome Coronavirus 2 Infection by Detection of Nucleocapsid Protein
•   Identification of a Potential Mechanism of Acute Kidney Injury During the Covid-19 Outbreak: A Study Based on Single-Cell Transcriptome Analysis
•   Latest updates on COVID-19 from the European Centre for Disease Prevention and Control