Clinical trial NCT04537975: C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19
Official title: A Randomized Clinical Trial of CLR2.0 Hemofiltration Treatment (C2Rx) in Severe or Critically Ill Adults With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Continuous Renal Replacement Therapy
Pulmonary Edema
COVID-19
Lead sponsor: SeaStar Medical
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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

Primary outcomes:
measure: Pulmonary Oxygenation Function
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Pulmonary Compliance of Respiratory System (CRS)
timeFrame: Up to 96 hours
measure: Survival
timeFrame: 30 days and 60 days
measure: Hospital Costs 1
timeFrame: Out to 60 days
measure: Cardiovascular Vasoactive-Inotropic Score (VIS)
timeFrame: Up to 96 hours
measure: Hospital Costs 2
timeFrame: Out to 60 days
measure: Hospital Costs 3
timeFrame: Out to 60 days
measure: Hospital Costs 4
timeFrame: Out to 60 days
measure: Hospital Costs 5
timeFrame: Out to 60 days
Other outcomes:
measure: Inflammatory mediators in blood
timeFrame: Out to 14 hours
measure: Cytokine Sieving Effects
timeFrame: Out to 8 hours
measure: Specific Blood Indicators 1
timeFrame: Out to 14 hours
measure: Specific Blood Indicators 2
timeFrame: Out to 14 hours
measure: Specific Blood Indicators 3
timeFrame: Out to 14 hours
measure: Specific Blood Indicators 4
timeFrame: Out to 14 hours
measure: Specific Blood Indicators 5
timeFrame: Out to 14 hours
measure: Specific Blood Indicators 6
timeFrame: Out to 14 hours
measure: Specific Blood Indicators 7
timeFrame: Out to 14 hours
measure: Specific Blood Indicators 8
timeFrame: Out to 14 hours
measure: Hospital Acquired Infections (HAI) /Sepsis
timeFrame: 30 and 60 days
measure: Composite Recovery
timeFrame: Up to 30 days
measure: Composite Survival
timeFrame: 30 and 60 days
measure: Composite Non-Recovery
timeFrame: Up to 60 days
Locations:
Study officials:
References: