AKINCT04395911
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
A study testing SCD in people with AKI and ARDS, run by SeaStar Medical at 3 sites in United States.
Trial summary
Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- SCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Sep 2020to 21 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained
- Positive COVID-19 test
- Must be receiving medical care in an intensive care nursing situation
- Non-pregnant females
- Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
- Platelet count >30,000/mm3 at Screening
- Clinical diagnosis of AKI requiring CRRT or ARDS
Who cannot join
- Cardiovascular instability that precludes initiation of continuous renal replacement therapy (CRRT).
- Irreversible brain damage based on available historical and clinical information.
- Presence of any solid organ transplant at any time.
- Patients with stem cell transplant in the previous 100 days or who have not engrafted.
- Acute or chronic use of circulatory support device other than ECMO such as LVADs, RVADs, BIVADs.
- Metastatic malignancy which is actively being treated or may be treated with chemotherapy or radiation during the subsequent three month period after study treatment.
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- Chronic immunosuppression defined as >20 mg prednisone qd alone without other immunosuppressant medications (ie (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine).
- Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
- Concurrent enrollment in another interventional clinical trial. Patients enrolled in observational studies (NO TEST DEVICE OR DRUG USED) are allowed to participate.
- Any reason the Investigator deems exclusionary.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Henry Ford Health System
Detroit, Michigan, 48202
University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: A Multi-Center Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Patients Developing Acute Kidney Injury (AKI) or Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 Infection
Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
- Being tested
- SCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCDDevice
cytopheretic device
| Study group | Role | What they receive |
|---|---|---|
| SCD | Other | Cytopheretic device Receives: Device: SCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at Day 60
All cause mortality at Day 60
Measured: 60 days post treatment
Dialysis Dependency
Dialysis Dependency at Day 60
Measured: 60 days post treatment
Ventilation at Day 28
Ventilation free survival at Day 28
Measured: 28 days post treatment
Secondary outcomes (6)
Dialysis Dependency
Dialysis Dependency at Day 28
Measured: 28 days post treatment
Mortality at Day 28
All cause mortality at Day 28
Measured: 28 days post treatment
Urinary output change
Change from baseline in urine output
Measured: 10 days of treatment
P02/FiO2 change
Change from baseline in PO2/FiO2
Measured: 10 days of treatment
Safety Assessments
Assessment of SAEs, AE and UADEs
Measured: 10 days of treatment
SCD Integrity
Assessment of device performance
Measured: 10 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start10 Sep 2020
- Primary completion5 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaStar Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395911
- Sponsor's protocol ID
- SCD-005
- Status last verified
- Aug 2021
- First submitted
- 17 May 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Unidentified participant data collected for this study will be submitted to a CRO for data analysis. All data will be submitted to the Sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Patients Developing Acute Kidney Injury (AKI) or Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04395911
- Acronym / sponsor ID
- SCD-005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SeaStar MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 20 May 2020 (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.
Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCD | Other | Device: SCDCytopheretic device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent obtained
- Positive COVID-19 test
- Must be receiving medical care in an intensive care nursing situation
- Non-pregnant females
- Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
Key exclusion criteria (10 listed)
- Cardiovascular instability that precludes initiation of continuous renal replacement therapy (CRRT).
- Irreversible brain damage based on available historical and clinical information.
- Presence of any solid organ transplant at any time.
- Patients with stem cell transplant in the previous 100 days or who have not engrafted.
- Acute or chronic use of circulatory support device other than ECMO such as LVADs, RVADs, BIVADs.
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 |
|---|---|---|
| SCDcytopheretic device | Device | SCD |
Primary outcome
Mortality at Day 60
Time frame: 60 days post treatment
All cause mortality at Day 60
Dialysis Dependency
Time frame: 60 days post treatment
Dialysis Dependency at Day 60
Ventilation at Day 28
Time frame: 28 days post treatment
Ventilation free survival at Day 28
6 secondary outcomes
Dialysis Dependency
Time frame: 28 days post treatment
Mortality at Day 28
Time frame: 28 days post treatment
Urinary output change
Time frame: 10 days of treatment
P02/FiO2 change
Time frame: 10 days of treatment
Safety Assessments
Time frame: 10 days of treatment
SCD Integrity
Time frame: 10 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: Yes. Unidentified participant data collected for this study will be submitted to a CRO for data analysis. All data will be submitted to the Sponsor.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCD in people with AKI and ARDS, run by SeaStar Medical at 3 sites 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality at Day 60 (time frame: 60 days post treatment). 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 5 Aug 2021.