C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19

• ClinicalTrials.gov Identifier: NCT04537975
• Recruitment Status: Withdrawn
• First Posted: September 3, 2020
• Last Update Posted: December 14, 2020
• Sponsor: SeaStar Medical
• Information provided by (Responsible Party): SeaStar Medical

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 .

Condition or disease	Intervention/treatment	Phase
Continuous Renal Replacement Therapy; Pulmonary Edema; COVID-19	Device: C2Rx; Other: Standard of Care (SOC)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of CLR2.0 Hemofiltration Treatment (C2Rx) in Severe or Critically Ill Adults With COVID-19 Infection
• Estimated Study Start Date: September 15, 2020
• Estimated Primary Completion Date: November 15, 2020
• Estimated Study Completion Date: January 15, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: C2Rx; Hemofiltration device	Device: C2Rx; Hemofiltration
Active Comparator: Standard of Care (SOC); Standard of Care based on protocol inclusion/exclusion criteria	Other: Standard of Care (SOC); Standard of care that excludes any protocol restrictions.

Outcome Measures

Primary Outcome Measures :

1. Pulmonary Oxygenation Function [ Time Frame: Up to 72 hours ]
   Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio

Secondary Outcome Measures :

1. Pulmonary Compliance of Respiratory System (CRS) [ Time Frame: Up to 96 hours ]
   Change in patient oxygenation
2. Survival [ Time Frame: 30 days and 60 days ]
   Change in the total number of patients that survived
3. Hospital Costs 1 [ Time Frame: Out to 60 days ]
   Change in Hospital Utilization of ventilators (days)
4. Cardiovascular Vasoactive-Inotropic Score (VIS) [ Time Frame: Up to 96 hours ]
   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)
5. Hospital Costs 2 [ Time Frame: Out to 60 days ]
   Change in Hospital Utilization of vasopressor medication (days without use)
6. Hospital Costs 3 [ Time Frame: Out to 60 days ]
   Change in Hospital Utilization of Intensive Care Unit (ICU) Hospital free days
7. Hospital Costs 4 [ Time Frame: Out to 60 days ]
   Change in Hospital Utilization of Renal Replacement Therapy (days on therapy)
8. Hospital Costs 5 [ Time Frame: Out to 60 days ]
   Change in Hospital Utilization (days hospitalized)

Other Outcome Measures:

1. Inflammatory mediators in blood [ Time Frame: Out to 14 hours ]
   Changes in inflammatory mediators detected by Immunoassay of Multianalyte Panel - MAP Laboratory Panel of 253 analytes.
2. Cytokine Sieving Effects [ Time Frame: Out to 8 hours ]
   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.
3. Specific Blood Indicators 1 [ Time Frame: Out to 14 hours ]
   Change in blood Ferritin (mg/mL)
4. Specific Blood Indicators 2 [ Time Frame: Out to 14 hours ]
   Change in blood Interleukin-6 (pg/mL)
5. Specific Blood Indicators 3 [ Time Frame: Out to 14 hours ]
   Change in blood C-reactive protein (CRP) (mg/L)
6. Specific Blood Indicators 4 [ Time Frame: Out to 14 hours ]
   Change in blood Lactate Dehydrogenase (LDH) (U/L)
7. Specific Blood Indicators 5 [ Time Frame: Out to 14 hours ]
   Change in blood D-dimer (mcg/L*FEU2)
8. Specific Blood Indicators 6 [ Time Frame: Out to 14 hours ]
   Change in blood White Blood Cell (WBC) count (%)
9. Specific Blood Indicators 7 [ Time Frame: Out to 14 hours ]
   Change in blood Neutrophil count (%)
10. Specific Blood Indicators 8 [ Time Frame: Out to 14 hours ]
    Change in blood lymphocyte count (%).
11. Hospital Acquired Infections (HAI) /Sepsis [ Time Frame: 30 and 60 days ]
    Change in the duration of days of diagnosed HAI/ Sepsis infections
12. Composite Recovery [ Time Frame: Up to 30 days ]
    Duration without Respiratory Replacement Therapy (RRT), ventilator, and time to discharge
13. Composite Survival [ Time Frame: 30 and 60 days ]
    Survival without Respiratory Replacement Therapy (RRT), ventilator, or time to Long Term Care (LTC)
14. Composite Non-Recovery [ Time Frame: Up to 60 days ]
    Survival with Respiratory Replacement Therapy (RRT), ventilator or in Long Term Care (LTC)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: SeaStar Medical
• ClinicalTrials.gov Identifier: NCT04537975
• Other Study ID Numbers: CP-01-004
• First Posted: September 3, 2020
• Last Update Posted: December 14, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Pulmonary Edema; Lung Diseases; Respiratory Tract Diseases