Long CovidLOCUSNCT06189066
Long COVID Ultrasound Trial
A study testing Splenic Ultrasound in people with Long Covid, run by SecondWave Systems Inc. at 1 site in United States.
Trial 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 disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long Covid
- What is being tested?
- Splenic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 24 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota - Phillips-Wangensteen Building
Minneapolis, Minnesota, 55455
About this study
Official title: Long COVID Ultrasound Trial [LOCUS 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.
Specific Aims include:
- Measure Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation.
- Measure molecular correlates of Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation.
- Track adverse events throughout the study to assess safety of the ultrasound intervention.
Read the 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 to treat inflammatory diseases including Long COVID.
In Long COVID, there can be a state of hyperinflammation that persists in those with symptoms months to years after infection. This hyperinflammatory state includes elevated proinflammatory cytokines such as interferon β (IFN-β), IFN-λ1, IFN-γ, CXCL9, CXCL10, interleukin-6 (IL-6), IL-8, IL-1β , and Tumor Necrosis Factor (TNF-α) in those with Long COVID. Prolonged inflammation in those with Long COVID plays a key role in its pathogenesis and in driving the persistent symptoms.
This study will employ investigational ultrasound devices produced by SecondWave Systems called the MINI ultrasound system.
This is a pilot single-arm intervention study in which up to 15 study participants will receive noninvasive splenic ultrasound therapy over eight weeks (five daily stimulation sessions per week). Participants will be enrolled in the study for a total of 12 weeks starting at Week 0. They will undergo a 4-week Baseline Period during which no intervention is delivered to determine how study outcomes may change over time. Then, after baseline outcomes are measured at Week 4, the investigational ultrasound interventional period will begin. Outcomes will be compared from baseline at Week 4 through the end of the 8-week intervention period at Week 12. Investigational splenic-ultrasound therapy will be delivered with the SecondWave MINI ultrasound system. The objective of the study is to assess the safety and potential efficacy of spleen ultrasound stimulation as an intervention for Long COVID in a pilot study.
For ultrasound stimulation, a small wearable ultrasound device is positioned on the upper left abdomen area over the ribs. Study personnel will use an ultrasound imaging device to locate the spleen and to position the wearable MINI device in a proper location around the ribs area. Daily stimulation consists of an approximately 18-minute period for application of ultrasound to the spleen. Collection of long-COVID outcome data, patient-reported assessments, and blood draws collected at the 6 study visits to assess biomarkers of inflammation will be performed in each participant throughout the study. Stool samples will be collected at 4 timepoints to assess changes in microbiome and metabolomics over the study period. Movement activity and sleep monitoring will be collected throughout the day and correlated with other study outcomes.
The study's primary outcome measure is the endurance shuttle walk test (ESWT) and the secondary outcome measure is the Chalder fatigue scale (CFQ-11). We will also investigate exploratory outcomes that will include other activity outcomes (e.g., total movement per day, sleep patterns), vital signs (e.g. heart rate and blood pressure), biomarker assessments (e.g., CRP, ESR, cortisol), cytokine assessments, microbiome and metabolomic related assessments, and device usability and experience assessments.
- Conditions
- Long Covid
- Being tested
- Splenic Ultrasound
- Keywords
- long covid, covid-19, long-haul COVID, post-COVID conditions (PCC), post-acute COVID-19, post-acute sequelae of SARS-CoV-2 infection (PASC), ultrasound, ultrasound stimulation, ultrasound treatment, ultrasound therapy
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splenic UltrasoundDevice
Also called SecondWave Systems investigational MINI device
Daily ultrasound application to the spleen of approximately 18 minutes per day, 5 days per week for up to 8 weeks, in addition to standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Group | Experimental | Not described Receives: Device: Splenic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-arm change in the endurance shuttle walk test (ESWT) from baseline to the completion of an up-to 8-week intervention period.
ESWT is a standardized, externally controlled, constant-paced walking test for the assessment of endurance capacity. Improvement in this outcome will be determined by an increase of distance walked and/or increase in time walked before failure to maintain the controlled walking pace.
Measured: 8 weeks
Secondary outcomes (2)
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.
CFQ-11 is a is a self-administered questionnaire for measuring the extent and severity of fatigue.
Measured: 8 weeks
Track adverse events throughout the study to assess the safety of the ultrasound intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start3 Jan 2024
- Primary completion24 Jul 2024
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long CovidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecondWave Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Farha Ikramuddin, M.D., Principal investigator, University of Minnesota Medical School, Department of Rehabilitation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189066
- Sponsor's protocol ID
- STUDY00020251
- Other IDs
- W911QY-21-9-0036
- Acronym
- LOCUS
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goggins E, Inoue H, Okusa MD. Neuroimmune Control of Inflammation in Acute Kidney Injury and Multiorgan Dysfunction. J Am Soc Nephrol. 2025 Dec 1;36(12):2473-2484. doi: 10.1681/ASN.0000000813. Epub 2025 Jul 7.
PubMed 40622772
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long COVID Ultrasound Trial [LOCUS Trial]
- ClinicalTrials.gov ID
- NCT06189066
- Acronym / sponsor ID
- LOCUS / STUDY00020251
- Conditions
- Long Covid
- Keywords
- long covid, covid-19, long-haul COVID, post-COVID conditions (PCC), post-acute COVID-19, post-acute sequelae of SARS-CoV-2 infection (PASC), ultrasound, ultrasound stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SecondWave Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota, United States Department of Defense
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation.
- Measure molecular correlates of Long COVID disease activity before, during and after an 8-week course of spleen-directed daily ultrasound stimulation.
- Track adverse events throughout the study to assess safety of the ultrasound intervention.
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 to treat inflammatory diseases including Long COVID.
In Long COVID, there can be a state of hyperinflammation that persists in those with symptoms months to years after infection. This hyperinflammatory state includes elevated proinflammatory cytokines such as interferon β (IFN-β), IFN-λ1, IFN-γ, CXCL9, CXCL10, interleukin-6 (IL-6), IL-8, IL-1β , and Tumor Necrosis Factor (TNF-α) in those with Long COVID. Prolonged inflammation in those with Long COVID plays a key role in its pathogenesis and in driving the persistent symptoms.
This study will employ investigational ultrasound devices produced by SecondWave Systems called the MINI ultrasound system.
This is a pilot single-arm intervention study in which up to 15 study participants will receive noninvasive splenic ultrasound therapy over eight weeks (five daily stimulation sessions per week). Participants will be enrolled in the study for a total of 12 weeks starting at Week 0. They will undergo a 4-week Baseline Period during which no intervention is delivered to determine how study outcomes may change over time. Then, after baseline outcomes are measured at Week 4, the investigational ultrasound interventional period will begin. Outcomes will be compared from baseline at Week 4 through the end of the 8-week intervention period at Week 12. Investigational splenic-ultrasound therapy will be delivered with the SecondWave MINI ultrasound system. The objective of the study is to assess the safety and potential efficacy of spleen ultrasound stimulation as an intervention for Long COVID in a pilot study.
For ultrasound stimulation, a small wearable ultrasound device is positioned on the upper left abdomen area over the ribs. Study personnel will use an ultrasound imaging device to locate the spleen and to position the wearable MINI device in a proper location around the ribs area. Daily stimulation consists of an approximately 18-minute period for application of ultrasound to the spleen. Collection of long-COVID outcome data, patient-reported assessments, and blood draws collected at the 6 study visits to assess biomarkers of inflammation will be performed in each participant throughout the study. Stool samples will be collected at 4 timepoints to assess changes in microbiome and metabolomics over the study period. Movement activity and sleep monitoring will be collected throughout the day and correlated with other study outcomes.
The study's primary outcome measure is the endurance shuttle walk test (ESWT) and the secondary outcome measure is the Chalder fatigue scale (CFQ-11). We will also investigate exploratory outcomes that will include other activity outcomes (e.g., total movement per day, sleep patterns), vital signs (e.g. heart rate and blood pressure), biomarker assessments (e.g., CRP, ESR, cortisol), cytokine assessments, microbiome and metabolomic related assessments, and device usability and experience assessments.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Group | Experimental | Device: Splenic Ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splenic UltrasoundAlso: SecondWave Systems investigational MINI deviceDaily ultrasound application to the spleen of approximately 18 minutes per day, 5 days per week for up to 8 weeks, in addition to standard clinical care. | Device | Ultrasound Group |
Primary outcome
Within-arm change in the endurance shuttle walk test (ESWT) from baseline to the completion of an up-to 8-week intervention period.
Time frame: 8 weeks
ESWT is a standardized, externally controlled, constant-paced walking test for the assessment of endurance capacity. Improvement in this outcome will be determined by an increase of distance walked and/or increase in time walked before failure to maintain the controlled walking pace.
2 secondary outcomes
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.
Time frame: 8 weeks
Track adverse events throughout the study to assess the safety of the ultrasound intervention.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 40622772Goggins E, Inoue H, Okusa MD. Neuroimmune Control of Inflammation in Acute Kidney Injury and Multiorgan Dysfunction. J Am Soc Nephrol. 2025 Dec 1;36(12):2473-2484. doi: 10.1681/ASN.0000000813. Epub 2025 Jul 7.
- Individual participant dataSharing planned: No
Related trials for Long Covid
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farha Ikramuddin, M.D. principal investigator
University of Minnesota Medical School, Department of Rehabilitation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splenic Ultrasound in people with Long Covid, run by SecondWave Systems Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-arm change in the endurance shuttle walk test (ESWT) from baseline to the completion of an up-to 8-week intervention period. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06189066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.