Continuous Renal Replacement TherapyNCT04537975
C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19
A study testing C2Rx in people with Continuous Renal Replacement Therapy and Pulmonary Edema, run by SeaStar Medical.
Trial summary
The clinical trial will evaluate the short term and extended impact on on respiration, pulmonary function and cardiovascular function in C2Rx treatment verse Standard of Care (SOC) in critically ill adults with COVID-19 infections . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Continuous Renal Replacement Therapy, Pulmonary Edema, COVID-19
- What is being tested?
- C2Rx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 15 Jan 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
- A patient, or legal authorized representative (LAR), has provided informed consent and a written informed consent form.
- Positive COVID-19 test.
- Must be receiving medical care in an intensive care nursing situation.
- Respiratory failure due to COVID-19 disease requiring invasive mechanical ventilation. This care may include but is not required to include the use of dexamethasone.
- Within 18 hours of tracheal intubation to support invasive mechanical ventilation. A goal of this study is that T0 will occur within 24 hours of tracheal intubation to support invasive mechanical ventilation.
- Age 18 to 80 years.
- Males and females (females of childbearing potential who are not pregnant confirmed by a negative serum pregnancy test) and not lactating if recently post-partum).
- Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
Who cannot join
- Cardiovascular instability that precludes initiation of hemofiltration.
- 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 such as extracorporeal membrane oxygenation (ECMO), left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), biventricular assist devices (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 use of any immunosuppressant medications (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine); prednisone use is excepted.
- Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
- Concurrent enrollment in another interventional clinical trial except trials of COVID-19 convalescent plasma, anti-severe acute respiratory syndrome (SARS)-CoV2 monoclonal antibodies, or RemdesivirTM. Patients enrolled in observational studies (without the use of an investigative device or drug), are allowed to participate. Any communication between the Principal Investigator (PI) of this Protocol and the PI of any other clinical study will include the Medical Director of the Sponsor; all such correspondence will be documented.
- Any reason the Investigator deems exclusionary
About this study
Official title: A Randomized Clinical Trial of CLR2.0 Hemofiltration Treatment (C2Rx) in Severe or Critically Ill Adults With COVID-19 Infection
The clinical trial will evaluate the short term and extended impact on on respiration, pulmonary function and cardiovascular function in C2Rx treatment verse Standard of Care (SOC) in critically ill adults with COVID-19 infections .
- Being tested
- C2Rx, Standard of Care (SOC)
- Medical subject headings
- Pulmonary Edema, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2RxDevice
Hemofiltration
Standard of Care (SOC)Other
Standard of care that excludes any protocol restrictions.
| Study group | Role | What they receive |
|---|---|---|
| C2Rx | Active comparator | Hemofiltration device Receives: Device: C2Rx |
| Standard of Care (SOC) | Active comparator | Standard of Care based on protocol inclusion/exclusion criteria Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Oxygenation Function
Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio
Measured: Up to 72 hours
Secondary outcomes (8)
Pulmonary Compliance of Respiratory System (CRS)
Change in patient oxygenation
Measured: Up to 96 hours
Survival
Change in the total number of patients that survived
Measured: 30 days and 60 days
Hospital Costs 1
Change in Hospital Utilization of ventilators (days)
Measured: Out to 60 days
Cardiovascular Vasoactive-Inotropic Score (VIS)
Change in score based on the calculation of the following medications used: dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x adrenaline dose (µg/kg/min) + 100 x noradrenaline dose (µg/kg/min) + 10 x milrinone dose (µg/kg/min) + 10.000 x vasopressin dose (U/kg/min)
Measured: Up to 96 hours
Hospital Costs 2
Change in Hospital Utilization of vasopressor medication (days without use)
Measured: Out to 60 days
Hospital Costs 3
Change in Hospital Utilization of Intensive Care Unit (ICU) Hospital free days
Measured: Out to 60 days
Hospital Costs 4
Change in Hospital Utilization of Renal Replacement Therapy (days on therapy)
Measured: Out to 60 days
Hospital Costs 5
Change in Hospital Utilization (days hospitalized)
Measured: Out to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Jan 2021 (estimated)
Why it stopped: Withdrawn (Study was withdrawn by Sponsor because of change in regulatory strategy.)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Renal Replacement TherapyStudies 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
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04537975
- Sponsor's protocol ID
- CP-01-004
- Status last verified
- Dec 2020
- First submitted
- 25 Aug 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of CLR2.0 Hemofiltration Treatment (C2Rx) in Severe or Critically Ill Adults With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04537975
- Acronym / sponsor ID
- CP-01-004
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn (Study was withdrawn by Sponsor because of change in regulatory strategy.)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SeaStar MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 3 Sep 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.
The clinical trial will evaluate the short term and extended impact on on respiration, pulmonary function and cardiovascular function in C2Rx treatment verse Standard of Care (SOC) in critically ill adults with COVID-19 infections .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C2Rx | Active comparator | Device: C2RxHemofiltration device |
| Standard of Care (SOC) | Active comparator | Other: Standard of Care (SOC)Standard of Care based on protocol inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A patient, or legal authorized representative (LAR), has provided informed consent and a written informed consent form.
- Positive COVID-19 test.
- Must be receiving medical care in an intensive care nursing situation.
- Respiratory failure due to COVID-19 disease requiring invasive mechanical ventilation. This care may include but is not required to include the use of dexamethasone.
- Within 18 hours of tracheal intubation to support invasive mechanical ventilation. A goal of this study is that T0 will occur within 24 hours of tracheal intubation to support invasive mechanical ventilation.
Key exclusion criteria (10 listed)
- Cardiovascular instability that precludes initiation of hemofiltration.
- 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 such as extracorporeal membrane oxygenation (ECMO), left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), biventricular assist devices (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 |
|---|---|---|
| C2RxHemofiltration | Device | C2Rx |
| Standard of Care (SOC)Standard of care that excludes any protocol restrictions. | Other | Standard of Care (SOC) |
Primary outcome
Pulmonary Oxygenation Function
Time frame: Up to 72 hours
Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio
8 secondary outcomes
Pulmonary Compliance of Respiratory System (CRS)
Time frame: Up to 96 hours
Survival
Time frame: 30 days and 60 days
Hospital Costs 1
Time frame: Out to 60 days
Cardiovascular Vasoactive-Inotropic Score (VIS)
Time frame: Up to 96 hours
Hospital Costs 2
Time frame: Out to 60 days
Hospital Costs 3
Time frame: Out to 60 days
Hospital Costs 4
Time frame: Out to 60 days
Hospital Costs 5
Time frame: Out to 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing C2Rx in people with Continuous Renal Replacement Therapy and Pulmonary Edema, run by SeaStar Medical.
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 8 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: withdrawn, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pulmonary Oxygenation Function (time frame: Up to 72 hours). 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 14 Dec 2020.