| Trial registration number
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NCT04854798 |
Full text link
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04854798
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First author
Last imported at : May 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Erik Peterson, M.D.
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Contact
Last imported at : May 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Daniel Zachs, unitestudyforcovid@gmail.com (PI email not reported)
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Registration date
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-04-22
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Recruitment status
Last imported at : March 30, 2022, 3 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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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 at a flow rate of 2 l/min or greater
- admission to the hospital
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Exclusion criteria
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- 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
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Number of arms
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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University of Minnesota
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Inclusion age min
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Moderate disease at enrollment
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Severity scale
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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3: Moderate disease at enrollment
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Total sample size
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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58
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primary outcome
Last imported at : April 29, 2021, 10:18 a.m.
Source : ClinicalTrials.gov
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IL-1β levels;IL-6 levels
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Notes
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1230, "treatment_name": "Splenic ultrasound", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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