Status:
UNKNOWN
UNITE Study (UCSD-SW) for COVID-19
Lead Sponsor:
Imanuel Lerman
Collaborating Sponsors:
SecondWave Systems Inc.
MCDC (Unites States Department of Defense)
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
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 2...
Detailed Description
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 babie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04803409
Start Date
March 22 2021
End Date
December 31 2021
Last Update
December 10 2021
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92037