UNITE Study (UMN-SW) for COVID-19

NCT04854798 | Completed

• 1 other identifier: Pro00050829
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

The research objective of the UNITE Study is to assess device feasibility of ultrasound application to the spleen using a small wearable ultrasound system to assess its effect on coronavirus disease 2019 (COVID-19) in a pilot study using an early stage prototype device. Specific Aims:

1. 1.Determine the feasibility of splenic ultrasound with a prototype wearable device in affecting physiological markers in COVID-19 infected patients between an ultrasound group versus a control group for the primary analyses; and
2. 2.Evaluate the potential capabilities of splenic ultrasound with this prototype wearable device in affecting additional outcomes in COVID-19 infected patients in the ultrasound group compared to a control group.

Conditions

Covid19; Cytokine Storm; Inflammation

Keywords

Covid19; Cytokine Storm; Inflammation

Outcome Measures

Primary Outcomes (2)

• IL-6 levels

  Percentage of participants with observed change in IL-6 levels

  Baseline to Day 8 (end of stimulation; or date of discharge or death if earlier)

• IL-1β levels

  Percentage of participants with observed change in IL-1β levels

  Baseline to Day 8 (end of stimulation; or date of discharge or death if earlier)

Secondary Outcomes (1)

• Hospitalized days based on the ordinal scale

  Baseline to date of recovery, assessed up to 14 days

Other Outcomes (13)

• Ordinal scale values over time

  Baseline to Day 8 (end of stimulation; last observation carried forward if date of discharge or death is earlier)

• CRP levels

  Baseline to Day 8 (end of stimulation; or date of discharge or death if earlier)

• Hypoxemia duration

  Baseline to date of discharge or date of death, whichever came first, assessed up to 6 months

Study Arms (2)

Ultrasound Group

EXPERIMENTAL

Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care.

Device: Splenic Ultrasound

Control Group

NO INTERVENTION

Control Group

Interventions

Splenic Ultrasound DEVICE

Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care

Also known as: SecondWave Systems investigational MINI device

Ultrasound Group

Eligibility Criteria

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

You may qualify if:

• Age 18 and above
• Positive for SARS-CoV-2 (via PCR)
• Decreased blood oxygen saturation: Room air SaO2 \< 94% and/or requiring supplemental oxygen at a flow rate of 2 L/min or greater
• Admission to the hospital

You may not qualify if:

• Pregnant women
• Asplenia
• Ascites
• Open wound/sores near the stimulation site
• Recent abdominal surgery
• Splenomegaly
• Mechanically ventilated (if patient goes onto mechanical ventilation while participating in the study, they can continue ultrasound treatment if recommended by SOC clinician and investigators of this study)
• Comfort care status
• Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study

Sponsors & Collaborators

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

Study Sites (2)

M Health Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

M Health Fairview St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

Related Links

• First-in-human demonstration of splenic ultrasound stimulation for non-invasively controlling inflammation

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome; Inflammation

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; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Erik Peterson, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Andrew Olson, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be randomized to two groups: ultrasound group and control group. All participants will still receive standard clinical care. The ultrasound group will receive daily ultrasound application to the spleen for up to 7 days, in addition to the standard clinical care. The control group will receive standard clinical care without ultrasound stimulation.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: April 29, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 11, 2022
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

US (2)