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

NCT04595903 | Terminated FDA Device

• 1 other identifier: AEMD-2020-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 9

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).

Conditions

COVID-19

Keywords

Hemopurifier; SARS-CoV-2; COVID-19; exosomes; plasmapheresis

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment emergent adverse events

  Safety and tolerability

  Day 1 (Date of Consent) to Day 28

• Incidence of device related adverse events

  Safety and tolerability with adverse event graded at 2 or higher

  Day 1 (Date of Consent) to Day 14

• Incidence of serious adverse events

  Safety and tolerability

  Day 1 (Date of Consent) to Day 28

Secondary Outcomes (13)

• Length if Stay in ICU

  Day 1 (Date of Consent) to Day 28

• In-hospital mortality

  Day 1 (Date of Consent) to Day 28

• Days free of ventilatory dependency

  Day 1 (Date of Consent) to Day 28

• Vasopressor-free days

  Day 1 (Date of Consent) to Day 28

• Sequential Organ Failure Assessment (SOFA)

  Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)

Study Arms (1)

Hemopurifier®

EXPERIMENTAL

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.

Device: Hemopurifier

Interventions

Hemopurifier DEVICE

Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days

Hemopurifier®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aethlon Medical Inc.: lead

Study Sites (9)

Hoag Hospital - Irvine

Irvine, California, 92618, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

UC Davis Health System

Sacramento, California, 95817, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

Related Publications (2)

• 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.

  PMID: 34692735 BACKGROUND

• 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.

  PMID: 35901224 BACKGROUND

Related Links

• Website
• Website

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven LaRosa, MD

  Aethlon Medical Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: June 1, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)