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Procedure

Ultrasound Group for Long COVID Syndrome (LOCUS Trial)

N/A
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

LOCUS Trial 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.

LOCUS Trial 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.

LOCUS Trial 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.

LOCUS 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

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
1,381 Previous Clinical Trials
1,588,760 Total Patients Enrolled
MCDC (United States Department of Defense)UNKNOWN
1 Previous Clinical Trials
58 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available openings for patients to participate in this medical study?

"As per the information available on clinicaltrials.gov, this specific clinical trial is not currently accepting new participants. The initial posting of the study was on January 3rd, 2024, with the most recent update occurring on December 31st, 2023. However, it should be noted that there are presently 128 other ongoing clinical trials actively recruiting patients at this time."

Answered by AI

What are the specific criteria for eligibility to participate in this medical study?

"To be eligible for enrollment in this clinical trial, individuals must have a diagnosis of long covid syndrome and fall between the ages of 18 and 65. The trial aims to recruit a total of 15 participants."

Answered by AI

Does this research trial accept individuals aged 50 years and above as study participants?

"Prospective participants for this research are required to be of legal age and younger than 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
University of Minnesota - Phillips-Wangensteen Building
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I believe I have severe persistent inflammation from long covid. Prednisone helps but once o stop it the inflammation returns.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there compensation for travel or time?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Long COVID Ultrasound Trial
2024. "Long COVID Ultrasound Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06189066.
All > Survivor Corps > Paid Studies Minneapolis
~6 spots leftby Jul 2024
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