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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04701489
Other study ID # OTOL-2020-29216
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2021
Est. completion date April 7, 2021

Study information

Verified date May 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research objective of the UNITE Study is to assess device feasibility of ultrasound application to the spleen to assess its effect on coronavirus disease 2019 (COVID-19) in a pilot study with an off-the-shelf ultrasound GE device originally used for diagnostic applications. Specific Aims: 1. Determine the feasibility of splenic ultrasound with an ultrasound device in affecting physiological markers in COVID-19 infected patients between an ultrasound group versus a control group for the primary analyses; and 2. Evaluate the potential capabilities of splenic ultrasound in affecting additional outcomes in COVID-19 infected patients in the ultrasound group compared to a control group.


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 COVID-19. COVID-19 is a disease caused by infection with the SARS-CoV-2 virus. Some COVID-19 patients develop a severe respiratory disease called acute respiratory distress syndrome and this disease is caused, in part, by a significant increase in inflammatory factors. Clinical therapies that reduce this elevated inflammation in the body (e.g., inflammation molecules in your body called cytokines) may be capable of diminishing symptoms in severe cases of COVID-19. Multiple studies in animals with hyper-inflammation conditions (e.g., inflammatory arthritis and sepsis/LPS injections) and recent human studies (e.g., for the treatment of joint inflammation in Rheumatoid Arthritis) have shown that ultrasound applied to the spleen can suppress blood/genetic markers of inflammation. Similar inflammatory markers, or cytokines, are elevated in the lungs of COVID-19 patients and believed to cause severe symptoms. Splenic ultrasound can potentially lower these inflammatory cytokines without hindering antibody production, leading to possible clinical improvements in COVID-19 patients. This study will employ off-the-shelf ultrasound devices produced by General Electric (GE LOGIQ E10 device with C1-6 ultrasound probe) that are currently used in hospitals and approved for diagnostic imaging by the FDA. The ultrasound energies applied to the spleen in this study in COVID-19 patients will not exceed what is currently approved for diagnostic imaging with those GE ultrasound devices. There will be two groups in this study with 15 participants in each group. One group will receive ultrasound application to the spleen, in addition to the standard clinical care. A control group will receive standard clinical care without splenic ultrasound. Each ultrasound application session will last about 15-20 minutes per day for 7 days, unless the participant is discharged sooner. For ultrasound stimulation, a small gel-coated probe is positioned on the upper left abdomen area over the ribs. The ultrasound session includes a period of 5-10 minutes when study personnel use the ultrasound device to locate the spleen and to position the ultrasound probe in a proper location around the ribs area, and an approximately 10-minute period for application of ultrasound to the spleen. Collection of various outcome data and daily blood draws will be performed in each participant throughout the study. Additional data collected from each participant during their routine clinical care beyond their study involvement will also be analyzed together with the study data to evaluate the specific aims of the clinical trial.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 7, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 and above - Positive for SARS-CoV-2 (via PCR) - Decreased blood oxygen saturation: Room air SaO2 < 94% and/or requiring supplemental oxygen to maintain SaO2 > 90% - Admission to the hospital Exclusion Criteria: - 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 standard of care clinician and investigators of the 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

Study Design


Intervention

Device:
Splenic ultrasound
GE LOGIQ E10 device with C1-6 ultrasound probe

Locations

Country Name City State
United States M Health Fairview St. Joseph's Hospital Saint Paul Minnesota

Sponsors (3)

Lead Sponsor Collaborator
University of Minnesota DARPA (Department of Defense), General Electric Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in death rate Baseline to date of discharge or date of death, whichever came first, assessed up to 6 months
Other Change in rate of requiring mechanical ventilation Baseline to date of discharge or date of death, whichever came first, assessed up to 6 months
Other Change in duration of hypoxemia Baseline to date of discharge or date of death, whichever came first, assessed up to 6 months
Other Change in D-dimer levels Baseline to Day 8 (end of stimulation; or date of discharge)
Other Change in serum cytokine concentration of TNF Baseline to Day 8 (end of stimulation; or date of discharge)
Other Change in serum cytokine concentration of IL-10 Baseline to Day 8 (end of stimulation; or date of discharge)
Other Change in serum cytokine concentration of IFN-gamma Baseline to Day 8 (end of stimulation; or date of discharge)
Other Change in serum cytokine concentration of IL-18 Baseline to Day 8 (end of stimulation; or date of discharge)
Other Change in serum cytokine concentration of IL2R-alpha Baseline to Day 8 (end of stimulation; or date of discharge)
Other Change in serum cytokine concentration of IL-4 Baseline to Day 8 (end of stimulation; or date of discharge)
Other Change in RNAseq identified pro-inflammatory pathways Baseline to Day 8 (end of stimulation; or date of discharge)
Primary IL-6 changes Percentage of participants with observed change in IL-6 level Baseline to Day 8 (end of stimulation; or date of discharge)
Primary IL-1ß changes Percentage of participants with observed change in IL-1ß level Baseline to Day 8 (end of stimulation; or date of discharge)
Primary CRP changes Percentage of participants with observed change in CRP level Baseline to Day 8 (end of stimulation; or date of discharge)
Secondary Change in time to recovery Day of recovery is defined as the first day on which the subject satisfies this category from the ordinal scale: Hospitalized, no oxygen therapy Baseline to date of recovery, assessed up to 21 days
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