Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Withdrawn (Study was withdrawn by Sponsor because of change in regulatory strategy.)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C2Rx | Active Comparator | Hemofiltration device |
|
| Standard of Care (SOC) | Active Comparator | Standard of Care based on protocol inclusion/exclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C2Rx | Device | Hemofiltration |
| |
| Standard of Care (SOC) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Oxygenation Function | Change in patient Arterial Oxygen Partial Pressure (PaO2)/Fractional Inspired Oxygen (FiO2) Ratio | Up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Compliance of Respiratory System (CRS) | Change in patient oxygenation | Up to 96 hours |
| Survival | Change in the total number of patients that survived |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory mediators in blood | Changes in inflammatory mediators detected by Immunoassay of Multianalyte Panel - MAP Laboratory Panel of 253 analytes. | Out to 14 hours |
| Cytokine Sieving Effects | Change in cytokine levels obtained from plasma and blood collected prior to and after filter. Analyte concentrations in ultrafiltrate and plasma, expressed in the same concentration units, will be aggregated as a ratio of ultrafiltrate concentration to plasma concentration to yield a unitless Sieving Coefficient (SC). SC is an index of membrane function. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011654 | Pulmonary Edema |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Standard of care that excludes any protocol restrictions. |
|
| 30 days and 60 days |
| Hospital Costs 1 | Change in Hospital Utilization of ventilators (days) | Out to 60 days |
| Cardiovascular Vasoactive-Inotropic Score (VIS) | Change in score based on the calculation of the following medications used: dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x adrenaline dose (µg/kg/min) + 100 x noradrenaline dose (µg/kg/min) + 10 x milrinone dose (µg/kg/min) + 10.000 x vasopressin dose (U/kg/min) | Up to 96 hours |
| Hospital Costs 2 | Change in Hospital Utilization of vasopressor medication (days without use) | Out to 60 days |
| Hospital Costs 3 | Change in Hospital Utilization of Intensive Care Unit (ICU) Hospital free days | Out to 60 days |
| Hospital Costs 4 | Change in Hospital Utilization of Renal Replacement Therapy (days on therapy) | Out to 60 days |
| Hospital Costs 5 | Change in Hospital Utilization (days hospitalized) | Out to 60 days |
| Out to 8 hours |
| Specific Blood Indicators 1 | Change in blood Ferritin (mg/mL) | Out to 14 hours |
| Specific Blood Indicators 2 | Change in blood Interleukin-6 (pg/mL) | Out to 14 hours |
| Specific Blood Indicators 3 | Change in blood C-reactive protein (CRP) (mg/L) | Out to 14 hours |
| Specific Blood Indicators 4 | Change in blood Lactate Dehydrogenase (LDH) (U/L) | Out to 14 hours |
| Specific Blood Indicators 5 | Change in blood D-dimer (mcg/L*FEU2) | Out to 14 hours |
| Specific Blood Indicators 6 | Change in blood White Blood Cell (WBC) count (%) | Out to 14 hours |
| Specific Blood Indicators 7 | Change in blood Neutrophil count (%) | Out to 14 hours |
| Specific Blood Indicators 8 | Change in blood lymphocyte count (%). | Out to 14 hours |
| Hospital Acquired Infections (HAI) /Sepsis | Change in the duration of days of diagnosed HAI/ Sepsis infections | 30 and 60 days |
| Composite Recovery | Duration without Respiratory Replacement Therapy (RRT), ventilator, and time to discharge | Up to 30 days |
| Composite Survival | Survival without Respiratory Replacement Therapy (RRT), ventilator, or time to Long Term Care (LTC) | 30 and 60 days |
| Composite Non-Recovery | Survival with Respiratory Replacement Therapy (RRT), ventilator or in Long Term Care (LTC) | Up to 60 days |
| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |