Back to resultsC2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19
Primary Purpose
Continuous Renal Replacement Therapy, Pulmonary Edema, COVID-19
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
C2Rx
Standard of Care (SOC)
Sponsored by
About this trial
This is an interventional treatment trial for Continuous Renal Replacement Therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
C2Rx
Standard of Care (SOC)
Arm Description
Hemofiltration device
Standard of Care based on protocol inclusion/exclusion criteria
Outcomes
Primary Outcome Measures
Pulmonary Oxygenation Function
Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio
Secondary Outcome Measures
Pulmonary Compliance of Respiratory System (CRS)
Change in patient oxygenation
Survival
Change in the total number of patients that survived
Hospital Costs 1
Change in Hospital Utilization of ventilators (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)
Hospital Costs 2
Change in Hospital Utilization of vasopressor medication (days without use)
Hospital Costs 3
Change in Hospital Utilization of Intensive Care Unit (ICU) Hospital free days
Hospital Costs 4
Change in Hospital Utilization of Renal Replacement Therapy (days on therapy)
Hospital Costs 5
Change in Hospital Utilization (days hospitalized)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04537975
Brief Title
C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19
Official Title
A Randomized Clinical Trial of CLR2.0 Hemofiltration Treatment (C2Rx) in Severe or Critically Ill Adults With COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn (Study was withdrawn by Sponsor because of change in regulatory strategy.)
Study Start Date
September 15, 2020 (Anticipated)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
January 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeaStar Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Renal Replacement Therapy, Pulmonary Edema, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C2Rx
Arm Type
Active Comparator
Arm Description
Hemofiltration device
Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
Standard of Care based on protocol inclusion/exclusion criteria
Intervention Type
Device
Intervention Name(s)
C2Rx
Intervention Description
Hemofiltration
Intervention Type
Other
Intervention Name(s)
Standard of Care (SOC)
Intervention Description
Standard of care that excludes any protocol restrictions.
Primary Outcome Measure Information:
Title
Pulmonary Oxygenation Function
Description
Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio
Time Frame
Up to 72 hours
Secondary Outcome Measure Information:
Title
Pulmonary Compliance of Respiratory System (CRS)
Description
Change in patient oxygenation
Time Frame
Up to 96 hours
Title
Survival
Description
Change in the total number of patients that survived
Time Frame
30 days and 60 days
Title
Hospital Costs 1
Description
Change in Hospital Utilization of ventilators (days)
Time Frame
Out to 60 days
Title
Cardiovascular Vasoactive-Inotropic Score (VIS)
Description
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)
Time Frame
Up to 96 hours
Title
Hospital Costs 2
Description
Change in Hospital Utilization of vasopressor medication (days without use)
Time Frame
Out to 60 days
Title
Hospital Costs 3
Description
Change in Hospital Utilization of Intensive Care Unit (ICU) Hospital free days
Time Frame
Out to 60 days
Title
Hospital Costs 4
Description
Change in Hospital Utilization of Renal Replacement Therapy (days on therapy)
Time Frame
Out to 60 days
Title
Hospital Costs 5
Description
Change in Hospital Utilization (days hospitalized)
Time Frame
Out to 60 days
Other Pre-specified Outcome Measures:
Title
Inflammatory mediators in blood
Description
Changes in inflammatory mediators detected by Immunoassay of Multianalyte Panel - MAP Laboratory Panel of 253 analytes.
Time Frame
Out to 14 hours
Title
Cytokine Sieving Effects
Description
Change in cytokine levels obtained from plasma and blood collected prior to and after filter. Analyte concentrations in ultrafiltrate and plasma, expressed in the same concentration units, will be aggregated as a ratio of ultrafiltrate concentration to plasma concentration to yield a unitless Sieving Coefficient (SC). SC is an index of membrane function.
Time Frame
Out to 8 hours
Title
Specific Blood Indicators 1
Description
Change in blood Ferritin (mg/mL)
Time Frame
Out to 14 hours
Title
Specific Blood Indicators 2
Description
Change in blood Interleukin-6 (pg/mL)
Time Frame
Out to 14 hours
Title
Specific Blood Indicators 3
Description
Change in blood C-reactive protein (CRP) (mg/L)
Time Frame
Out to 14 hours
Title
Specific Blood Indicators 4
Description
Change in blood Lactate Dehydrogenase (LDH) (U/L)
Time Frame
Out to 14 hours
Title
Specific Blood Indicators 5
Description
Change in blood D-dimer (mcg/L*FEU2)
Time Frame
Out to 14 hours
Title
Specific Blood Indicators 6
Description
Change in blood White Blood Cell (WBC) count (%)
Time Frame
Out to 14 hours
Title
Specific Blood Indicators 7
Description
Change in blood Neutrophil count (%)
Time Frame
Out to 14 hours
Title
Specific Blood Indicators 8
Description
Change in blood lymphocyte count (%).
Time Frame
Out to 14 hours
Title
Hospital Acquired Infections (HAI) /Sepsis
Description
Change in the duration of days of diagnosed HAI/ Sepsis infections
Time Frame
30 and 60 days
Title
Composite Recovery
Description
Duration without Respiratory Replacement Therapy (RRT), ventilator, and time to discharge
Time Frame
Up to 30 days
Title
Composite Survival
Description
Survival without Respiratory Replacement Therapy (RRT), ventilator, or time to Long Term Care (LTC)
Time Frame
30 and 60 days
Title
Composite Non-Recovery
Description
Survival with Respiratory Replacement Therapy (RRT), ventilator or in Long Term Care (LTC)
Time Frame
Up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19
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