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C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19 | Clinical Trials | Clareo Health

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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

NCT04537975•SeaStar Medical

View on ClinicalTrials.gov

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 .

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 15, 2020

Primary Completion Date

November 15, 2020

Completion Date

January 15, 2021

Last Updated

December 14, 2020

Conditions

Continuous Renal Replacement TherapyPulmonary EdemaCOVID-19

Interventions

C2Rx

DEVICE

Standard of Care (SOC)

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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