UNITE Study (UCSD-SW) for COVID-19

NCT04803409 | Unknown DMC

• 1 other identifier: 201611
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The research objective of the UNITE Study is to assess the potential efficacy of ultrasound application to the spleen using a small wearable ultrasound system in the treatment of coronavirus disease 2019 (COVID-19) in a pilot study. Specific Aims: Determine the efficacy of splenic ultrasound in affecting markers of systemic inflammation in COVID-19 infection. Evaluate the potential efficacy of splenic ultrasound in affecting clinical outcomes in COVID-19 infection. Condition or disease: Covid19: Cytokine Storm Inflammation Device: Splenic Ultrasound Phase: Not Applicable

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

• IL-6 Change

  Between-arm change of IL-6 levels from baseline to end of treatment between groups

  Baseline to Day 8 (end of treatment; or date of discharge)

• IL-1β

  Between-arm change of IL-1β levels from baseline to end of treatment between groups

  Baseline to Day 8 (end of treatment; or date of discharge

• CRP

  Between-arm change of CRP levels from baseline to end of treatment between groups

  Baseline to Day 8 (end of treatment; or date of discharge)

Secondary Outcomes (1)

• Change in time to recovery

  Baseline to date of recovery, assessed up to 6 months

Other Outcomes (10)

• Change in death rate

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

• Change in rate of requiring mechanical ventilation

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

• Change in duration of hypoxemia

  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

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

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
• 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
• On-duty Federal Employees and Military Personnel
• Patient without decision making capacity as determined by clinical judgement informed by communication with the UCSD primary Hospitalist team
• 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

• Imanuel Lerman: lead
• SecondWave Systems Inc.: collaborator
• MCDC (Unites States Department of Defense): collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst Clin Prof

Model Details: Intervention Model Description: 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: March 16, 2021
• First Posted: March 17, 2021
• Study Start: March 22, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)