What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Non-invasive treatments for Long COVID Syndrome, such as spleen ultrasound stimulation, are generally considered safe with minimal side effects. Common side effects of similar non-invasive therapies may include mild discomfort at the site of application, transient fatigue, and occasional headaches. Immune modulation techniques, while promising, can sometimes lead to immune system overactivity or suppression, potentially causing mild to moderate flu-like symptoms. However, more extensive studies are needed to fully understand the safety profile of these treatments.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Long COVID Syndrome. The research on spleen ultrasound stimulation is a novel approach aimed at modulating the immune response to reduce symptoms. Current treatments for Long COVID are generally supportive and symptomatic, focusing on managing individual symptoms such as fatigue, respiratory issues, and cognitive dysfunction. Clinical trials are ongoing to explore various therapeutic options, including immunomodulatory therapies, but no specific drug has received FDA approval for this condition yet.

What other types of research exist?

Promising novel alternatives to spleen ultrasound stimulation for Long COVID Syndrome patients include: 1) Lung ultrasound (LUS) for monitoring and potentially guiding treatment, 2) Gastric electrical stimulation, which has shown immune-modulating effects in other conditions, and 3) Warm cupping therapy, which has demonstrated symptom improvement in COVID-19 patients with ARDS. These alternatives offer non-invasive or minimally invasive options that may help modulate the immune response and reduce symptoms.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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

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I am between 18 and 65 years old.

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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:

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I have had a stroke in the past.

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

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I have had Lyme disease in the past.

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I have had severe anemia with hemoglobin below 8 g/dl.

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I have a long-term liver condition like cirrhosis.

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I have sickle cell disease with spleen issues.

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I have a history of heart artery disease.

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I do not speak English.

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I am using treatments for Long COVID that are not officially approved.

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I am currently serving in the military or work for the Department of Defense.

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I cannot or will not delay starting new Long COVID treatments during the study.

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I was put on a ventilator because of COVID-19.

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I was admitted to the ICU for COVID-19.

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I have a lung condition like COPD, ILD, or severe asthma.

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I have a history of chronic fatigue syndrome.

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I experience long-term fatigue not caused by COVID-19.

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I have been diagnosed with fibromyalgia.

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I have had issues with my spleen, like enlargement or tissue death.

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I have had my spleen removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Within-arm change in the endurance shuttle walk test (ESWT) from baseline to the completion of an up-to 8-week intervention period.

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 21Eligibility criteria met

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.