Status:
COMPLETED
Long COVID Ultrasound Trial
Lead Sponsor:
SecondWave Systems Inc.
Collaborating Sponsors:
University of Minnesota
MCDC (United States Department of Defense)
Conditions:
Long Covid
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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. Specific Aims include: * Measure Long COVID...
Detailed Description
Ultrasound is widely used in human medicine because it is safe, non-invasive, and painless. The same kind of ultrasound that is used for imaging (for example, to visualize babies in utero) may be able...
Eligibility Criteria
Inclusion
- Age 18-65 years at the time of enrollment
- Prior diagnosis of COVID-19 by report, PCR, or home kit
- 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)
Exclusion
- Candidate who is unable or unwilling to postpone taking new medications used for treating Long COVID during the study period
- Candidate that is currently taking immune modifying medications and unable to maintain stable levels of their immune medication regimen throughout the study period
- History of intubation secondary to COVID-19
- ICU admission for COVID-19
- Pre-existing Lung conditions such as chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or severe asthma
- Pregnant
- History of coronary artery disease (CAD)
- History of stroke
- History of severe anemia of hemoglobin less than 8 g/dl
- Prior history of Lyme disease
- Prior history cognitive impairment
- Any non-marijuana drug abuse history within 30 days
- Current use of an investigational drug
- History of prior myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS)
- History of alcohol abuse: greater than 2 drinks a day for men and 1 drink for females
- Prior history of postural orthostatic tachycardia syndrome (POTS)
- Chronic fatigue secondary to any condition other than COVID-19.
- Fibromyalgia
- History of prior chronic pain
- History of chronic liver disease such as cirrhosis
- History of splenic pathology such as spleen infarct/splenomegaly
- History of splenectomy
- History of Sickle disease with splenic pathology
- Taking non-approved treatments for Long COVID
- Participant does not speak English
- Participant is an active member of the military (service member) or DoD personnel (including civilian employees)
- Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06189066
Start Date
January 3 2024
End Date
July 24 2025
Last Update
January 7 2026
Active Locations (1)
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1
University of Minnesota - Phillips-Wangensteen Building
Minneapolis, Minnesota, United States, 55455