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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04701489 |
|
Full text link
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-01-08 |
|
Recruitment status
Last imported at : April 24, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Aug. 11, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- 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 |
|
Number of arms
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
University of Minnesota |
|
Inclusion age min
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
|
Severity scale
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
|
Total sample size
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
30 |
|
primary outcome
Last imported at : Jan. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Between-arm change of CRP levels from baseline to end of treatment between groups;Between-arm change of IL-1β levels from baseline to end of treatment between groups;Between-arm change of IL-6 levels from baseline to end of treatment between groups |
|
Notes
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Jan. 10, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"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"}] |