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

Primary Purpose

COVID-19

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hemopurifier
Sponsored by
Aethlon Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Hemopurifier, SARS-CoV-2, COVID-19, exosomes, plasmapheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hoag Hospital - Irvine
  • Loma Linda University Medical Center
  • Hoag Memorial Hospital Presbyterian
  • UC Davis Health System
  • University of Miami Hospital
  • LSU Health Sciences Center
  • Cooper University Hospital
  • Thomas Jefferson University Hospital
  • Valley Baptist Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemopurifier®

Arm Description

The Hemopurifier® will be placed within the extracorporeal circuit, all connections secured, treatment will utilize a blood pump at a flow rate of up to 200mL/min. The patients will be monitored for adverse events, device deficiencies and the development of hemodynamic instability. The treatment session will be for 4-6 hours once daily for 4 consecutive days.

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events
Safety and tolerability
Incidence of device related adverse events
Safety and tolerability with adverse event graded at 2 or higher
Incidence of serious adverse events
Safety and tolerability

Secondary Outcome Measures

Length if Stay in ICU
Length of ICU stay in days
In-hospital mortality
Number of deaths during hospitalization
Days free of ventilatory dependency
Number of days without ventilatory support
Vasopressor-free days
Number of days without vasopressor support
Sequential Organ Failure Assessment (SOFA)
SOFA scoring system predicts the clinical outcome of critically ill patients.
Acute Physiology and Chronic Health Evaluation (APACHE)
Measures the severity of disease for adult patients admitted to an ICU
SARS CoV-2 RNA levels in plasma and nasopharyngeal samples
Measures viral exposure and levels of circulating virus
Total lymphocyte count
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
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
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
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
Measures the levels of SARS-CoV-2 RNA captured in the filter
Evaluation of viral particle load post-treatment Hemopurifier cartridges
Measures the levels of viral particles captured in the filter

Full Information

First Posted
October 8, 2020
Last Updated
December 16, 2022
Sponsor
Aethlon Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04595903
Brief Title
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
Official Title
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of eligible COVID-ICU patients
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 14, 2022 (Actual)
Study Completion Date
November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aethlon Medical Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
Up to 40 ICU patients with severe or critical illness due to confirmed COVID-19 infection will be enrolled in up to 20 investigational sites. 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 patients will be monitored closely with vital signs and for hemodynamic stability. Patients will be followed for adverse events and device deficiencies. Blood work will be obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Hemopurifier, SARS-CoV-2, COVID-19, exosomes, plasmapheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This trial will evaluate the use of the Hemopurifier in patients with SARS-CoV-2 Virus Disease (COVID-19). The Hemopurifier is an extracorporeal device device that combines plasma filtration, size exclusion and affinity binding of mannosylated structures including enveloped viruses and exosomes. The study will evaluate whether the device is safe in COVID-19 patients along with clearing virus and improving outcomes in infected patients. 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)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemopurifier®
Arm Type
Experimental
Arm Description
The Hemopurifier® will be placed within the extracorporeal circuit, all connections secured, treatment will utilize a blood pump at a flow rate of up to 200mL/min. The patients will be monitored for adverse events, device deficiencies and the development of hemodynamic instability. The treatment session will be for 4-6 hours once daily for 4 consecutive days.
Intervention Type
Device
Intervention Name(s)
Hemopurifier
Intervention Description
Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Description
Safety and tolerability
Time Frame
Day 1 (Date of Consent) to Day 28
Title
Incidence of device related adverse events
Description
Safety and tolerability with adverse event graded at 2 or higher
Time Frame
Day 1 (Date of Consent) to Day 14
Title
Incidence of serious adverse events
Description
Safety and tolerability
Time Frame
Day 1 (Date of Consent) to Day 28
Secondary Outcome Measure Information:
Title
Length if Stay in ICU
Description
Length of ICU stay in days
Time Frame
Day 1 (Date of Consent) to Day 28
Title
In-hospital mortality
Description
Number of deaths during hospitalization
Time Frame
Day 1 (Date of Consent) to Day 28
Title
Days free of ventilatory dependency
Description
Number of days without ventilatory support
Time Frame
Day 1 (Date of Consent) to Day 28
Title
Vasopressor-free days
Description
Number of days without vasopressor support
Time Frame
Day 1 (Date of Consent) to Day 28
Title
Sequential Organ Failure Assessment (SOFA)
Description
SOFA scoring system predicts the clinical outcome of critically ill patients.
Time Frame
Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)
Title
Acute Physiology and Chronic Health Evaluation (APACHE)
Description
Measures the severity of disease for adult patients admitted to an ICU
Time Frame
Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)
Title
SARS CoV-2 RNA levels in plasma and nasopharyngeal samples
Description
Measures viral exposure and levels of circulating virus
Time Frame
Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinued
Title
Total lymphocyte count
Description
Measurement of lymphocytes as there seems to be a correlation with the disease severity and lymphopenia.
Time Frame
Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Title
C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests
Description
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.
Time Frame
Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Title
D-dimer
Description
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.
Time Frame
Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Title
Troponin-T
Description
Measurement of Troponin-T as high levels of troponin is found in COVID-19 patients.
Time Frame
Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Title
Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges
Description
Measures the levels of SARS-CoV-2 RNA captured in the filter
Time Frame
Until study completion, 1 week or for the duration of ICU admission
Title
Evaluation of viral particle load post-treatment Hemopurifier cartridges
Description
Measures the levels of viral particles captured in the filter
Time Frame
Until study completion, 1 week or for the duration of ICU admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Admission to the ICU or area of the hospital repurposed to function as an ICU for surge capacity management 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 Informed consent from the patient or legally authorized representative Age > 18 Exclusion Criteria: Stroke (known or suspected) within the last 3 months. Severe congestive heart failure (NYHA III and IV classes). Biopsy proven cancer not in remission. 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. Known pre-existing non-COVID-19 related hypercoagulability or other coagulopathy 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. Patients with known hypersensitivity to any component of the Hemopurifier. Advance directive indicating to withhold life-sustaining treatment (except Cardiopulmonary Resuscitation). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven LaRosa, MD
Organizational Affiliation
Aethlon Medical Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hoag Hospital - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
UC Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Valley Baptist Medical Center
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34692735
Citation
Amundson DE, Shah US, de Necochea-Campion R, Jacobs M, LaRosa SP, Fisher CJ Jr. Removal of COVID-19 Spike Protein, Whole Virus, Exosomes, and Exosomal MicroRNAs by the Hemopurifier(R) Lectin-Affinity Cartridge in Critically Ill Patients With COVID-19 Infection. Front Med (Lausanne). 2021 Oct 8;8:744141. doi: 10.3389/fmed.2021.744141. eCollection 2021.
Results Reference
background
PubMed Identifier
35901224
Citation
Gooldy M, Roux CM, LaRosa SP, Spaulding N, Fisher CJ Jr. Removal of clinically relevant SARS-CoV-2 variants by an affinity resin containing Galanthus nivalis agglutinin. PLoS One. 2022 Jul 28;17(7):e0272377. doi: 10.1371/journal.pone.0272377. eCollection 2022.
Results Reference
background
Links:
URL
https://www.frontiersin.org/articles/10.3389/fmed.2021.744141/full
Description
Website
URL
https://www.biorxiv.org/content/10.1101/2022.04.27.489436v1.full
Description
Website

Learn more about this trial

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

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