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

NCT ID: NCT04537975

Last Updated: 2020-12-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C2Rx

Hemofiltration device

Group Type: ACTIVE_COMPARATOR

C2Rx

Intervention Type: DEVICE

Hemofiltration

Standard of Care (SOC)

Standard of Care based on protocol inclusion/exclusion criteria

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: OTHER

Standard of care that excludes any protocol restrictions.

Interventions

C2Rx

Hemofiltration

Intervention Type: DEVICE

Standard of Care (SOC)

Standard of care that excludes any protocol restrictions.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SeaStar Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CP-01-004

Identifier Type: -

Identifier Source: org_study_id