Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
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|ClinicalTrials.gov Identifier: NCT04595903|
Recruitment Status : Terminated (Lack of eligible COVID-ICU patients)
First Posted : October 22, 2020
Last Update Posted : December 20, 2022
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Device: Hemopurifier||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|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 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)|
|Official Title:||Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device|
|Actual Study Start Date :||June 1, 2022|
|Actual Primary Completion Date :||November 14, 2022|
|Actual Study Completion Date :||November 14, 2022|
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.
Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595903
|United States, California|
|Hoag Hospital - Irvine|
|Irvine, California, United States, 92618|
|Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|Hoag Memorial Hospital Presbyterian|
|Newport Beach, California, United States, 92663|
|UC Davis Health System|
|Sacramento, California, United States, 95817|
|United States, Florida|
|University of Miami Hospital|
|Miami, Florida, United States, 33136|
|United States, Louisiana|
|LSU Health Sciences Center|
|Shreveport, Louisiana, United States, 71103|
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Valley Baptist Medical Center|
|Harlingen, Texas, United States, 78550|
|Study Director:||Steven LaRosa, MD||Aethlon Medical Inc.|
|Responsible Party:||Aethlon Medical Inc.|
|Other Study ID Numbers:||
|First Posted:||October 22, 2020 Key Record Dates|
|Last Update Posted:||December 20, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases