Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Newport Beach, California and other locations
Dates
study started
estimated completion

Description

Summary

This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).

Official Title

Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device

Details

The study population will be patients with COVID-19 who are severely affected or at high risk for severe disease. Up to 40 patients with symptoms of COVID-19 infection are confirmed by Real-Time Reverse Transcriptase (RT)-PCR, will be enrolled in up to 20 investigational sites. Once patients are identified and consented, either a double-lumen hemodialysis catheter, arteriovenous fistula, or graft must be present for treatment. Patients will receive a four to six-hour treatment with the Hemopurifier® extracorporeal therapy daily for up to four days until discontinued because of clinical improvement or deterioration or upon the decision of the Principal Investigator. The Hemopurifier® will be placed within the extracorporeal circuit and with all connections secured, treatment will utilize a blood pump at an initial flow rate of 100mL/min. The blood flow rate is to be increased gradually in a stepwise fashion over the first minutes to a maximum blood flow rate of 200mL/min. The circuit must be continually monitored for blood leaks and blood clotting within the device. If the treatment is halted before 4 hours, another device may be connected, and the treatment may be restarted with a goal of achieving a minimum of 4 hours of therapy. If the device shows signs of clotting or blood leaks, the treatment must be paused, the blood will be returned to the patient and a new device will be placed within the extracorporeal circuit. The therapy will be resumed with consideration of altering the level of anticoagulation.

Keywords

SARS (Severe Acute Respiratory Syndrome) Hemopurifier SARS COVID-19 Cytokine Storm Severe Acute Respiratory Syndrome Virus Diseases Hemopurifier®

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Laboratory diagnosis of COVID-19 infection with any of the following disease characteristics:
  2. 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:
  • respiratory failure,
  • septic shock, and/or
  • multiple organ dysfunction or failure.
  • Admission to the ICU.
  • Stable blood pressure not requiring vasopressors.
  • Established central access, have received recent hemodialysis and are hemodynamically stable (mean arterial pressure > 70 without vasopressors other than low dose for renal perfusion, HR < 120)
  • Informed consent from the patient or legal representative using the associated Patient Informed Consent form must be completed.
  • Age > 18

You CAN'T join if...

  1. Stroke (known or suspected).
  2. Severe congestive heart failure (NYHA III and IV classes).
  3. Biopsy proven cancer not in remission.
  4. Patients with acute or chronic liver failure.
  5. Known pre-existing non-COVID-19 related hypercoagulability or other coagulopathy.
  6. Concurrent CRRT
  7. Terminal illness with a life expectancy of < 28 days or for whom a decision of withdrawal of care is in place or imminently anticipated.
  8. Patients with known hypersensitivity to any component of the Hemopurifier.
  9. Advance directive indicating no desire for heroic measures.
  10. . Voluntary refusal of the patient or the designated legal representative.
  11. . Contraindications to extracorporeal blood purification therapy such as:
  12. Clinically relevant bleeding disorder, ii. Contraindication to anti-coagulation, iii. Pregnancy, iv. Inability to establish functional vascular access, v. Severe hemodynamic instability, vi. Participation in another competing investigational drug, device or vaccine trial, vii. Administration of an angiotensin converting enzyme (ACE) inhibitor in the previous 14 days.
  13. . Recent history of unstable or untreated intradialytic hypotension

Locations

  • Hoag Memorial Hospital Presbyterian
    Newport Beach California 92663 United States
  • Hoag Hospital - Irvine
    Irvine California 92618 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aethlon Medical Inc.
Links
Website Sign up for this study
ID
NCT04595903
Study Type
Interventional
Last Updated