Phase 3
N=4
Contrast Enhanced Ultrasound in COVID-19
Covid19 · Multisystem Inflammatory Syndrome in Children (MIS-C)
Bottom Line
View on ClinicalTrials.gov: NCT04640038 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain — 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sulfur hexafluoride lipid-type A microspheres (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain |
2; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Medical history of Lumason hypersensitivity
Data sourced from ClinicalTrials.gov (NCT04640038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.