Splenic Ultrasound for Long COVID

(LOCUS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SecondWave Systems Inc.

Must not be taking: Immune modifying medications

Disqualifiers: COPD, CAD, Stroke, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

15 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

You may need to stop taking new medications for Long COVID during the study, and if you're on immune-modifying medications, you must keep them stable throughout the study. The protocol does not specify other medication restrictions.

How is splenic ultrasound treatment for Long COVID different from other treatments?

Splenic ultrasound is unique because it uses sound waves to create images of the spleen, potentially identifying abnormalities that other treatments might miss. Unlike medications, it is a non-invasive imaging technique that can provide additional information about the spleen's condition without the need for surgery or drugs. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new treatment for Long COVID using a small device that sends sound waves to the spleen. The goal is to see if this can reduce inflammation and improve symptoms in patients who have had ongoing issues after their initial COVID-19 infection.

Research Team

Farha Ikramuddin, M.D.

Principal Investigator

University of Minnesota Medical School, Department of Rehabilitation Medicine

Eligibility Criteria

This trial is for individuals experiencing Long COVID symptoms. Participants should be able to undergo daily spleen-directed ultrasound stimulation for 8 weeks. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

Prior diagnosis of COVID-19 by report, PCR, or home kit

I have had fatigue and other symptoms like muscle pain or brain fog for over 12 weeks since recovering from COVID-19.

Exclusion Criteria

I have had a stroke in the past.

I cannot keep my immune medication levels stable during the study.

I have had Lyme disease in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a 4-week Baseline Period during which no intervention is delivered to determine how study outcomes may change over time

4 weeks

1 visit (in-person)

Treatment

Participants receive noninvasive splenic ultrasound therapy over eight weeks with five daily stimulation sessions per week

8 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Splenic Ultrasound

Trial Overview The trial is testing whether stimulating the spleen with ultrasound can help people with Long COVID. Over an 8-week period, researchers will monitor disease activity and molecular changes related to Long COVID before, during, and after treatment.

Participant Groups

Group I: Ultrasound Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

SecondWave Systems Inc.

Lead Sponsor

Trials

4

Recruited

130+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

MCDC (United States Department of Defense)

Collaborator

Trials

2

Recruited

70+

References

1. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasound of the spleen. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

B-Mode Ultrasound and Contrast-Enhanced Ultrasound for the Detection of Splenic Involvement in Hodgkin Lymphoma: A Retrospective Analysis of 112 Patients. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Role of contrast-enhanced ultrasound (CEUS) in the diagnosis and management of traumatic splenic injuries. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Splenic abscess diagnosed by ultrasound in the pediatric patient. Report of three cases. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Vascular pattern and diagnostic accuracy of contrast-enhanced ultrasound (CEUS) in spleen alterations. [2020]