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

Study Overview
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Brief Summary
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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 .

Official Title
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A Randomized Clinical Trial of CLR2.0 Hemofiltration Treatment (C2Rx) in Severe or Critically Ill Adults With COVID-19 Infection

Conditions
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Continuous Renal Replacement Therapy, Pulmonary Edema, COVID-19

Intervention / Treatment
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* Device: C2Rx
* Other: Standard of Care (SOC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C2Rx<br>Hemofiltration device | Device: C2Rx<br>* Hemofiltration<br>|
| Active Comparator: Standard of Care (SOC)<br>Standard of Care based on protocol inclusion/exclusion criteria | Other: Standard of Care (SOC)<br>* Standard of care that excludes any protocol restrictions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Oxygenation Function | Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio | Up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Compliance of Respiratory System (CRS) | Change in patient oxygenation | Up to 96 hours | 
| Survival | Change in the total number of patients that survived | 30 days and 60 days | 
| Hospital Costs 1 | Change in Hospital Utilization of ventilators (days) | 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) | Up to 96 hours | 
| Hospital Costs 2 | Change in Hospital Utilization of vasopressor medication (days without use) | Out to 60 days | 
| Hospital Costs 3 | Change in Hospital Utilization of Intensive Care Unit (ICU) Hospital free days | Out to 60 days | 
| Hospital Costs 4 | Change in Hospital Utilization of Renal Replacement Therapy (days on therapy) | Out to 60 days | 
| Hospital Costs 5 | Change in Hospital Utilization (days hospitalized) | Out to 60 days |