COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04537975

Eric Schlorff

Eric@seastarmed.com

2020-09-03

Withdrawn

RCT

Randomized

Parallel

Open label

unclear

Treatment

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.

- 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

2

SeaStar Medical

18

80

None

Critical disease at enrollment

8: Critical disease at enrollment

0

Pulmonary Oxygenation Function

None

Not reported

[{"arm_notes": "", "treatment_id": 303, "treatment_name": "Clr2.0 hemofiltration treatment (c2rx)", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]