Long COVID Ultrasound Trial

NCT06189066 | Completed FDA Device

• 2 other identifiers: STUDY00020251W911QY-21-9-0036
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

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; ultrasound treatment; ultrasound therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  8 weeks

• Track adverse events throughout the study to assess the safety of the ultrasound intervention.

  8 weeks

Study Arms (1)

Ultrasound Group

EXPERIMENTAL

Device: Splenic Ultrasound

Interventions

Splenic Ultrasound 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.

Also known as: SecondWave Systems investigational MINI device

Ultrasound Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SecondWave Systems Inc.: lead
• University of Minnesota: collaborator
• MCDC (United States Department of Defense): collaborator

Study Sites (1)

University of Minnesota - Phillips-Wangensteen Building

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 40622772 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Farha Ikramuddin, M.D.

  University of Minnesota Medical School, Department of Rehabilitation Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 3, 2024
• Study Start: January 3, 2024
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)