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Contrast Agent

Contrast Enhanced Ultrasound for COVID-19

Phase 3
Waitlist Available
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes.
Awards & highlights

Study Summary

This trial is looking at using a safe imaging tool to see how well different organs are being perfused in children with COVID-19, and to see if there is a correlation between the findings and clinical outcomes.

Eligible Conditions
  • Multisystem Inflammatory Syndrome in Children
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimate the Proportion of Patients With Normal Perfusion Versus Area(s) of Hypoperfusion in Heart, Kidneys and/or Brain

Trial Design

1Treatment groups
Experimental Treatment
Group I: Contrast-enhanced UltrasonographyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulfur hexafluoride lipid-type A microspheres
2020
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
707 Previous Clinical Trials
8,581,287 Total Patients Enrolled

Media Library

Sulfur hexafluoride lipid-type A microspheres (Contrast Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04640038 — Phase 3
Multisystem Inflammatory Syndrome in Children Research Study Groups: Contrast-enhanced Ultrasonography
Multisystem Inflammatory Syndrome in Children Clinical Trial 2023: Sulfur hexafluoride lipid-type A microspheres Highlights & Side Effects. Trial Name: NCT04640038 — Phase 3
Sulfur hexafluoride lipid-type A microspheres (Contrast Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04640038 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being sought for this research project?

"This trial is only for children under 18 years old. In total, there are 153 similar studies for minors and 989 trials for adults 65 and older."

Answered by AI

Are Sulfur hexafluoride lipid-type A microspheres government certified for patient use?

"There is ample evidence both supporting the efficacy and safety of Sulfur hexafluoride lipid-type A microspheres, as this medication has gone through Phase 3 clinical trials."

Answered by AI

What other studies does this one compare to?

"Since 2017, Sulfur hexafluoride lipid-type A microspheres have been the subject of 16 active studies across 10 cities and 3 countries. The first study occurred in 2017 and was sponsored by Bracco Diagnostics, Inc. Following the initial study, which involved 125 patients, Sulfur hexafluoride lipid-type A microspheres received its Phase < 1 drug approval."

Answered by AI

How many human subjects will be included in the final data analysis for this research?

"Yes, you are correct. The listing on clinicaltrials.gov does show that the research team is currently looking for more participants. This specific trial was posted on December 18th, 2020 and last updated January 26th, 2022. They are hoping to enroll 30 individuals total at just 1 location."

Answered by AI

What does the research say about Sulfur hexafluoride lipid-type A microspheres?

"There are currently 16 ongoing clinical trials for Sulfur hexafluoride lipid-type A microspheres, 3 of which have reached Phase 3. Although a few of the investigations are taking place in Salt Lake City, Utah, there are 20 total sites running these sorts of tests."

Answered by AI
Recent research and studies
Kidney InternationalJournal
Kidney Disease Is Associated with In-hospital Death of Patients with COVID-19
Cheng, Yichun, Ran Luo, Kun Wang, Meng Zhang, Zhixiang Wang, Lei Dong, Junhua Li, Ying Yao, Shuwang Ge, and Gang Xu. 2020. “Kidney Disease Is Associated with In-hospital Death of Patients with COVID-19”. Kidney International. Elsevier BV. doi:10.1016/j.kint.2020.03.005.
clinicaltrials.govStudy
Contrast Enhanced Ultrasound in COVID-19
Misun Hwang, MD 2020. "Contrast Enhanced Ultrasound in COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04640038.
~1 spots leftby Apr 2025
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