Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT04595903
Eligibility Criteria:
Inclusion Criteria:
1. Laboratory diagnosis of COVID-19 infection with any of the following disease characteristics:
i. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS) ii. Severe disease, defined as:
* dyspnea,
* respiratory frequency ≥ 30/min,
* blood oxygen saturation ≤ 93%,,
* partial pressure of arterial oxygen to fraction of inspired oxygen ratio of \<300 and/or
* lung infiltrates \>50% within 24 to 48 hours; iii. Life-threatening disease, defined as:
1. respiratory failure,
2. septic shock, and/or
3. multiple organ dysfunction or failure.
2. Admission to the ICU or area of the hospital repurposed to function as an ICU for surge capacity management
3. Subject has maintained a MAP of \> or = 65 without an increased dose of vasopressors for at least 2 hours and has clinical evidence of adequate volume status per investigative site criteria
4. Informed consent from the patient or legally authorized representative
5. Age \> 18
Exclusion Criteria:
1. Stroke (known or suspected) within the last 3 months.
2. Severe congestive heart failure (NYHA III and IV classes).
3. Biopsy proven cancer not in remission.
4. Acute (an international normalized ratio (INR) of greater than 1.5, and any degree of mental alteration (encephalopathy) in a patient without preexisting cirrhosis and with an illness of less than 26weeks' duration or chronic (Child Pugh C) liver disease.
5. Known pre-existing non-COVID-19 related hypercoagulability or other coagulopathy
6. Terminal illness with a life expectancy of \< 28 days or for whom a decision of withdrawal of care is in place or imminently anticipated or patients who have received prior extracorporeal therapy and had persistent, unstable hypotension.
7. Patients with known hypersensitivity to any component of the Hemopurifier.
8. Advance directive indicating to withhold life-sustaining treatment (except Cardiopulmonary Resuscitation).
9. Contraindications to extracorporeal blood purification therapy such as:
i. Clinically relevant bleeding disorder, ii. Contraindication to anti-coagulation, iii. Pregnancy, iv. Inability to establish functional vascular access, v. Participation in another competing investigational drug, device or vaccine trial vi. Administration of an angiotensin converting enzyme (ACE) inhibitor in the previous 14 days. vii. Platelet count \< 50,000 cells/microliter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04595903
Study Brief:
Protocol Section:
NCT04595903