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

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 .

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; Continuous Renal Replacement Therapy; Pulmonary Edema
• Intervention / Treatment: Device: C2Rx; Other: Standard of Care (SOC)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: SeaStar Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2020
• Primary Completion (Anticipated): November 15, 2020
• Study Completion (Anticipated): January 15, 2021

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Pulmonary Edema
• Other Study ID Numbers: CP-01-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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