← Back to Search

Procedure

Splenic Ultrasound for Long COVID (LOCUS Trial)

N/A
Waitlist Available
Led By Farha Ikramuddin, M.D.
Research Sponsored by SecondWave Systems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years at the time of enrollment
Symptoms present for 12 or more weeks that are independent prior to SARS-CoV-2 infection including fatigue and one or more of: Myalgia or general aches/pains, Joint pain, Dizziness/lightheadedness, Cognitive dysfunction (brain fog)
Must not have
History of stroke
Candidate that is currently taking immune modifying medications and unable to maintain stable levels of their immune medication regimen throughout the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial aims to test the safety and effectiveness of using ultrasound stimulation on the spleen as a treatment for Long COVID. The study will measure the activity of the disease before, during, and after

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of spleen-directed ultrasound are not listed, the study aims to track any adverse events throughout its duration to ensure safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I have had fatigue and other symptoms like muscle pain or brain fog for over 12 weeks since recovering from COVID-19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a stroke in the past.
Select...
I cannot keep my immune medication levels stable during the study.
Select...
I have had Lyme disease in the past.
Select...
I have had severe anemia with hemoglobin below 8 g/dl.
Select...
I have a long-term liver condition like cirrhosis.
Select...
I have sickle cell disease with spleen issues.
Select...
I have a history of heart artery disease.
Select...
I do not speak English.
Select...
I am using treatments for Long COVID that are not officially approved.
Select...
I am currently serving in the military or work for the Department of Defense.
Select...
I cannot or will not delay starting new Long COVID treatments during the study.
Select...
I was put on a ventilator because of COVID-19.
Select...
I was admitted to the ICU for COVID-19.
Select...
I have a lung condition like COPD, ILD, or severe asthma.
Select...
I have a history of chronic fatigue syndrome.
Select...
I experience long-term fatigue not caused by COVID-19.
Select...
I have been diagnosed with fibromyalgia.
Select...
I have had issues with my spleen, like enlargement or tissue death.
Select...
I have had my spleen removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Within-arm change in the endurance shuttle walk test (ESWT) from baseline to the completion of an up-to 8-week intervention period.
Secondary outcome measures
Track adverse events throughout the study to assess the safety of the ultrasound intervention.
Within-arm change in the Chalder fatigue scale (CFQ-11; Likert score) from baseline to the completion of an up-to 8-week intervention period.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ultrasound GroupExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Splenic Ultrasound
2021
N/A
~80

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Long COVID Syndrome include rest, good sleep hygiene, and energy conservation strategies like the 'four-P' approach (Planning, Pacing, Prioritizing, and Positioning). These methods help manage fatigue and improve functional status by allowing patients to gradually increase their activity levels without exacerbating symptoms. Investigational treatments, such as spleen ultrasound stimulation, aim to modulate the immune response and reduce symptoms by non-invasively stimulating the spleen, potentially decreasing inflammation and improving overall health. These approaches are crucial for Long COVID patients as they address persistent symptoms and aim to restore quality of life.
Successful outcome using Tocilizumab in COVID-19 pneumonia with respiratory failure on a ward level.Autoimmune connective tissue diseases in the COVID-19 pandemic.

Find a Location

Who is running the clinical trial?

SecondWave Systems Inc.Lead Sponsor
3 Previous Clinical Trials
112 Total Patients Enrolled
University of MinnesotaOTHER
1,395 Previous Clinical Trials
1,553,310 Total Patients Enrolled
MCDC (United States Department of Defense)UNKNOWN
1 Previous Clinical Trials
58 Total Patients Enrolled
~10 spots leftby Jul 2025