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Trial record 2 of 3 for:    Aethlon

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

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ClinicalTrials.gov Identifier: NCT04595903
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Aethlon Medical Inc.

Tracking Information
First Submitted Date  ICMJE October 8, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date January 14, 2021
Estimated Study Start Date  ICMJE January 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2020)
  • Incidence of treatment emergent adverse events [ Time Frame: Day 1 (Date of Consent) to Day 28 ]
    Safety and tolerability
  • Incidence of device related adverse events [ Time Frame: Day 1 (Date of Consent) to Day 14 ]
    Safety and tolerability with adverse event graded at 2 or higher
  • Incidence of serious adverse events [ Time Frame: Day 1 (Date of Consent) to Day 28 ]
    Safety and tolerability
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2020)
  • Length if Stay in ICU [ Time Frame: Day 1 (Date of Consent) to Day 28 ]
    Length of ICU stay in days
  • In-hospital mortality [ Time Frame: Day 1 (Date of Consent) to Day 28 ]
    Number of deaths during hospitalization
  • Days free of ventilatory dependency [ Time Frame: Day 1 (Date of Consent) to Day 28 ]
    Number of days without ventilatory support
  • Vasopressor-free days [ Time Frame: Day 1 (Date of Consent) to Day 28 ]
    Number of days without vasopressor support
  • Sequential Organ Failure Assessment (SOFA) [ Time Frame: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more) ]
    SOFA scoring system predicts the clinical outcome of critically ill patients.
  • Acute Physiology and Chronic Health Evaluation (APACHE) [ Time Frame: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more) ]
    Measures the severity of disease for adult patients admitted to an ICU
  • SARS CoV-2 RNA levels in plasma and nasopharyngeal samples [ Time Frame: Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinued ]
    Measures viral exposure and levels of circulating virus
  • Total lymphocyte count [ Time Frame: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more) ]
    Measurement of lymphocytes as there seems to be a correlation with the disease severity and lymphopenia.
  • C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests [ Time Frame: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more) ]
    Measurement of inflammatory marker levels play a role in systemic vasculitis and cytokine mediated coagulation disorders as the principal actors of multi organ failure in patients with severe COVID-19 complication.
  • D-dimer [ Time Frame: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more) ]
    Measurement of D-dimer levels as levels are elevated in patients with COVID-19 and correlate with disease severity, are a reliable prognostic marker for in-hospital mortality.
  • Troponin-T [ Time Frame: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more) ]
    Measurement of Troponin-T as high levels of troponin is found in COVID-19 patients.
  • Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges [ Time Frame: Until study completion, 1 week or for the duration of ICU admission ]
    Measures the levels of SARS-CoV-2 RNA captured in the filter
  • Evaluation of viral particle load post-treatment Hemopurifier cartridges [ Time Frame: Until study completion, 1 week or for the duration of ICU admission ]
    Measures the levels of viral particles captured in the filter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
Official Title  ICMJE Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
Brief 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This trial will evaluate the use of the Hemopurifier in patients with SARS-CoV-2 Virus Disease (COVID-19). The Hemopurifier is a blood filtration device similar to a kidney dialysis cartridge which is designed to remove viruses including SARS-CoV-2. The study will evaluate whether the device is safe in COVID-19 patients along with clearing virus and improving outcomes in infected patients. Enrolled subjects will already have a large intravenous catheter placed for the treatment of kidney injury and will have their blood filtered through the Hemopurifier. Subjects 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 decision of the Principal Investigator.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE SARS (Severe Acute Respiratory Syndrome)
Intervention  ICMJE Device: Hemopurifier
Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days
Study Arms  ICMJE Experimental: Hemopurifier®
The Hemopurifier® will be placed within the extracorporeal circuit, 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 of treatment to a maximum blood flow rate of 200mL/min. The circuit must be continually monitored for blood leaks and blood clotting within the filter. If the treatment is halted before 4 hours, another filter may be connected, and the treatment may be restarted with a goal of achieving a minimum of 4 hours of therapy. If the filter shows signs of clotting or blood leaks, the treatment must be paused, the blood will be returned to the patient and a new filter will be placed into the extracorporeal circuit. The therapy will be resumed with consideration of altering the level of anticoagulation.
Intervention: Device: Hemopurifier
Publications * Büttner S, Koch B, Dolnik O, Eickmann M, Freiwald T, Rudolf S, Engel J, Becker S, Ronco C, Geiger H. Extracorporeal virus elimination for the treatment of severe Ebola virus disease--first experience with lectin affinity plasmapheresis. Blood Purif. 2014;38(3-4):286-91. doi: 10.1159/000375229. Epub 2015 Feb 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  3. Stable blood pressure not requiring vasopressors.
  4. 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)
  5. Informed consent from the patient or legal representative using the associated Patient Informed Consent form must be completed.
  6. Age > 18

Exclusion Criteria:

  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:

    i. 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.

  12. Recent history of unstable or untreated intradialytic hypotension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Boswell 303-503-9954 lboswell@aethlonmedical.com
Contact: Monica Kellogg 303-829-6344 mkellogg@aethlonmedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04595903
Other Study ID Numbers  ICMJE AEMD-2020-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aethlon Medical Inc.
Study Sponsor  ICMJE Aethlon Medical Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Usman Shah, MD Hoag Memorial Hospital Presbyterian
PRS Account Aethlon Medical Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP