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

NCT04537975 | Withdrawn FDA Device

• 1 other identifier: CP-01-004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Continuous Renal Replacement Therapy; Pulmonary Edema; COVID-19

Outcome Measures

Primary Outcomes (1)

• Pulmonary Oxygenation Function

  Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio

  Up to 72 hours

Secondary Outcomes (8)

• Pulmonary Compliance of Respiratory System (CRS)

  Up to 96 hours

• Survival

  30 days and 60 days

• Hospital Costs 1

  Out to 60 days

• Cardiovascular Vasoactive-Inotropic Score (VIS)

  Up to 96 hours

• Hospital Costs 2

  Out to 60 days

Other Outcomes (14)

• Inflammatory mediators in blood

  Out to 14 hours

• Cytokine Sieving Effects

  Out to 8 hours

• Specific Blood Indicators 1

  Out to 14 hours

Study Arms (2)

C2Rx

ACTIVE COMPARATOR

Hemofiltration device

Device: C2Rx

Standard of Care (SOC)

ACTIVE COMPARATOR

Standard of Care based on protocol inclusion/exclusion criteria

Other: Standard of Care (SOC)

Interventions

C2Rx DEVICE

Hemofiltration

C2Rx

Standard of Care (SOC) OTHER

Standard of care that excludes any protocol restrictions.

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SeaStar Medical: lead

MeSH Terms

Conditions

Pulmonary Edema; COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 3, 2020
• Study Start: September 15, 2020
• Primary Completion: November 15, 2020
• Study Completion: January 15, 2021
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share