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

Not Applicable

Terminated

• Conditions: COVID-19
• Interventions: Device: Hemopurifier

• Registration Number: NCT04595903
• Lead Sponsor: Aethlon Medical Inc.

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.

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-17
• Study First Posted: 2020-10-22
• Study Start: 2022-06-01
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemopurifier®	Hemopurifier	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.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	Day 1 (Date of Consent) to Day 28	Safety and tolerability
Incidence of device related adverse events	Day 1 (Date of Consent) to Day 14	Safety and tolerability with adverse event graded at 2 or higher
Incidence of serious adverse events	Day 1 (Date of Consent) to Day 28	Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA)	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)	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	Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinued	Measures viral exposure and levels of circulating virus
Length if Stay in ICU	Day 1 (Date of Consent) to Day 28	Length of ICU stay in days
In-hospital mortality	Day 1 (Date of Consent) to Day 28	Number of deaths during hospitalization
Days free of ventilatory dependency	Day 1 (Date of Consent) to Day 28	Number of days without ventilatory support
Vasopressor-free days	Day 1 (Date of Consent) to Day 28	Number of days without vasopressor support
Total lymphocyte count	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	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	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	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	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	Until study completion, 1 week or for the duration of ICU admission	Measures the levels of viral particles captured in the filter

Trial Locations

Locations (9)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

LSU Health Sciences Center; 🇺🇸 Shreveport, Louisiana, United States

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Hoag Hospital - Irvine; 🇺🇸 Irvine, California, United States

Valley Baptist Medical Center; 🇺🇸 Harlingen, Texas, United States

University of Miami Hospital; 🇺🇸 Miami, Florida, United States

UC Davis Health System; 🇺🇸 Sacramento, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States