CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4 enrolled
Drug / intervention
Sulfur hexafluoride lipid-type A microspheresdrug
Likely dose
Sulfur hexafluoride lipid-type A microspheres 0.03 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04640038
NCT04640038Phase 3Completed

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

Children's Hospital of Philadelphia·interventional·Posted Nov 23, 2020·Updated Jul 30, 2024

In Brief

A Phase 3 clinical trial evaluating Sulfur hexafluoride lipid-type A microspheres for Covid19 and Multisystem Inflammatory Syndrome in Children (MIS-C). Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedNov 23, 2020
Enrollment StartDec 18, 2020
Primary CompletionSep 17, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.6 years ago

Interventions

Sulfur hexafluoride lipid-type A microspheresdrug

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.