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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04595903
• Other study ID #: AEMD-2020-02
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: December 2022
• Source: Aethlon Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	Hoag Hospital - Irvine	Irvine	California
United States	Loma Linda University Medical Center	Loma Linda	California
United States	University of Miami Hospital	Miami	Florida
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	UC Davis Health System	Sacramento	California
United States	LSU Health Sciences Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Aethlon Medical Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events	Safety and tolerability	Day 1 (Date of Consent) to Day 28
Primary	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
Primary	Incidence of serious adverse events	Safety and tolerability	Day 1 (Date of Consent) to Day 28
Secondary	Length if Stay in ICU	Length of ICU stay in days	Day 1 (Date of Consent) to Day 28
Secondary	In-hospital mortality	Number of deaths during hospitalization	Day 1 (Date of Consent) to Day 28
Secondary	Days free of ventilatory dependency	Number of days without ventilatory support	Day 1 (Date of Consent) to Day 28
Secondary	Vasopressor-free days	Number of days without vasopressor support	Day 1 (Date of Consent) to Day 28
Secondary	Sequential Organ Failure Assessment (SOFA)	SOFA scoring system predicts the clinical outcome of critically ill patients.	Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)
Secondary	Acute Physiology and Chronic Health Evaluation (APACHE)	Measures the severity of disease for adult patients admitted to an ICU	Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)
Secondary	SARS CoV-2 RNA levels in plasma and nasopharyngeal samples	Measures viral exposure and levels of circulating virus	Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinued
Secondary	Total lymphocyte count	Measurement of lymphocytes as there seems to be a correlation with the disease severity and lymphopenia.	Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Secondary	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.	Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Secondary	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.	Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Secondary	Troponin-T	Measurement of Troponin-T as high levels of troponin is found in COVID-19 patients.	Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Secondary	Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges	Measures the levels of SARS-CoV-2 RNA captured in the filter	Until study completion, 1 week or for the duration of ICU admission
Secondary	Evaluation of viral particle load post-treatment Hemopurifier cartridges	Measures the levels of viral particles captured in the filter	Until study completion, 1 week or for the duration of ICU admission

External Links

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