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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using ultrasound on the spleen can help treat Long COVID symptoms. Researchers will monitor symptom changes over an 8-week period and check for any side effects. It is suitable for individuals who have experienced symptoms like fatigue, aches, or brain fog for at least 12 weeks following a confirmed COVID-19 diagnosis. Participants should not have severe lung issues or a history of certain chronic conditions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for Long COVID.

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.

What prior data suggests that spleen ultrasound is safe for Long COVID?

Research on using ultrasound to stimulate the spleen is quite new, and limited information exists on its safety for treating Long COVID. In this early study, researchers closely monitor any side effects from the ultrasound treatment.

As the study is in its initial stages, the main goal is to assess the treatment's safety and observe participants' reactions. No specific safety data from past studies exists for this exact use. However, ultrasound is generally considered a safe and non-invasive method used in many medical procedures.

By monitoring any unexpected problems during the study, researchers will gain insights into how well participants tolerate this treatment. Prospective participants should know that the treatment is still under careful testing to determine its safety for Long COVID. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Long COVID focus on managing symptoms like fatigue and brain fog through medications or therapies. However, Splenic Ultrasound is unique because it targets the spleen, which plays a role in immune system regulation. This approach could potentially reset immune responses, offering a new way to address the root causes of Long COVID. Researchers are excited about this technique because it might provide relief without relying on drugs, making it a non-invasive and potentially safer alternative for patients.

What evidence suggests that splenic ultrasound is effective for Long COVID?

Research has shown that COVID-19 can affect the spleen, leading to issues like lower white blood cell counts and damage from reduced blood flow. This involvement suggests the spleen plays a role in how the virus impacts the body. In this trial, participants will undergo splenic ultrasound, which might help manage these effects by stimulating the spleen. Although strong clinical evidence on its effectiveness for Long COVID is not yet available, the theory remains promising. Early studies aim to determine if this method can lessen symptoms and improve health for those with Long COVID. ^{1 2 4 6 7}

Who Is on the Research Team?

Farha Ikramuddin, M.D.

Principal Investigator

University of Minnesota Medical School, Department of Rehabilitation Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06189066

Study Details | NCT06189066 | Long COVID Ultrasound Trial The research objective is to assess the safety and potential efficacy of spleen ultrasound stimulation as an intervention for Long COVID in a pilot study.

2. reaganudall.org reaganudall.org/clinical-trial/long-covid-ultrasound-trial

Long COVID Ultrasound Trial The research objective is to assess the safety and potential efficacy of spleenultrasound stimulation as an intervention for Long COVID in a pilot study.

3. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06189066

Splenic Ultrasound in Long Covid - Clinical Trials Registry The research objective is to assess the safety and potential efficacy of spleen ultrasound stimulation as an intervention for Long COVID in a pilot study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10705853/

Splenic infarction: an uncommon yet significant ... The findings indicated a direct impact of the virus on the spleen, evident through a decline in lymphocyte counts. These results emphasize the significance of ...

5. ejgm.co.uk ejgm.co.uk/download/clinical-and-morphological-changes-of-the-spleen-in-covid-19-patients-with-and-without-splenectomy-14935.pdf

clinical-and-morphological-changes-of-the-spleen-in-covid ... Patients diagnosed with COVID-19 were seen to develop splenic infarction or abscess. This study aims to estimate.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493926/

Post-acute sequelae of SARS-CoV-2 infection (Long COVID ... Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

7. nature.com nature.com/articles/s41392-023-01640-z

The long-term health outcomes, pathophysiological ... We comprehensively review the current literature on long COVID, highlighting its epidemiological understanding, the impact of vaccinations, organ-specific ...