Covid19UNITENCT04803409
UNITE Study (UCSD-SW) for COVID-19
A study testing Splenic Ultrasound in people with Covid19, run by Imanuel Lerman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Splenic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92037
About this study
Official title: Ultrasound Neural and Immunomodulation Treatment Evaluation Study (UCSD-SW) for COVID-19
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
Read the 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 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 clinical improvements in COVID-19 patients.
This study will employ investigational ultrasound devices produced by SecondWave Systems called the MINI System (Miniature Immunotherapy and Neuromodulation Instrument System).
There will be two groups in this study with 20 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 30 minutes per day for 7 days, unless the participant is discharged sooner. For ultrasound stimulation, a small wearable ultrasound device is positioned on the upper left abdomen area over the ribs. The ultrasound session on the first study day includes a period of 5-10 minutes when study personnel use an ultrasound imaging device to locate the spleen and to position the wearable MINI device in a proper location around the ribs area, and an approximately 18-minute period for application of ultrasound to the spleen. Collection of clinical outcome data and daily blood draws will be performed in each participant throughout the study through Day 8. 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.
Study Design Go to sections Study Type : Interventional (Clinical Trial) Estimated Enrollment : 40 participants Allocation: Randomized Intervention Model: Parallel Assignment 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.
Primary Purpose: Other
- Conditions
- Covid19
- Being tested
- Splenic Ultrasound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splenic UltrasoundDevice
Splenic Ultrasound: Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Group | Experimental | Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care. Receives: Device: Splenic Ultrasound |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 Change
Between-arm change of IL-6 levels from baseline to end of treatment between groups
Measured: 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
Measured: 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
Measured: Baseline to Day 8 (end of treatment; or date of discharge)
Secondary outcomes (1)
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
Measured: Baseline to date of recovery, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start22 Mar 2021
- Primary completion15 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imanuel Lerman
- Sponsor type
- University, hospital or other
- Collaborators
- SecondWave Systems Inc., United States Department of Defense
- Responsible party
- Sponsor-investigator, Imanuel Lerman, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803409
- Sponsor's protocol ID
- 201611
- Acronym
- UNITE
- Status last verified
- Dec 2021
- First submitted
- 16 Mar 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Neural and Immunomodulation Treatment Evaluation Study (UCSD-SW) for COVID-19
- ClinicalTrials.gov ID
- NCT04803409
- Acronym / sponsor ID
- UNITE / 201611
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Imanuel LermanUniversity, hospital or other
- Collaborators
- SecondWave Systems Inc., United States Department of Defense
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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 clinical improvements in COVID-19 patients.
This study will employ investigational ultrasound devices produced by SecondWave Systems called the MINI System (Miniature Immunotherapy and Neuromodulation Instrument System).
There will be two groups in this study with 20 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 30 minutes per day for 7 days, unless the participant is discharged sooner. For ultrasound stimulation, a small wearable ultrasound device is positioned on the upper left abdomen area over the ribs. The ultrasound session on the first study day includes a period of 5-10 minutes when study personnel use an ultrasound imaging device to locate the spleen and to position the wearable MINI device in a proper location around the ribs area, and an approximately 18-minute period for application of ultrasound to the spleen. Collection of clinical outcome data and daily blood draws will be performed in each participant throughout the study through Day 8. 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.
Study Design Go to sections Study Type : Interventional (Clinical Trial) Estimated Enrollment : 40 participants Allocation: Randomized Intervention Model: Parallel Assignment 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.
Primary Purpose: Other
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Group | Experimental | Device: Splenic UltrasoundDaily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care. |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splenic UltrasoundSplenic Ultrasound: Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care | Device | Ultrasound Group |
Primary outcome
IL-6 Change
Time frame: Baseline to Day 8 (end of treatment; or date of discharge)
Between-arm change of IL-6 levels from baseline to end of treatment between groups
IL-1β
Time frame: Baseline to Day 8 (end of treatment; or date of discharge
Between-arm change of IL-1β levels from baseline to end of treatment between groups
CRP
Time frame: Baseline to Day 8 (end of treatment; or date of discharge)
Between-arm change of CRP levels from baseline to end of treatment between groups
1 secondary outcome
Change in time to recovery
Time frame: Baseline to date of recovery, assessed up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Covid19
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splenic Ultrasound in people with Covid19, run by Imanuel Lerman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 Change (time frame: Baseline to Day 8 (end of treatment; or date of discharge)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.