COVID-19NCT04595903
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
A study testing Hemopurifier in people with COVID-19, run by Aethlon Medical Inc. at 9 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hemopurifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jun 2022to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laboratory diagnosis of COVID-19 infection with any of the following disease characteristics:
- 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
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- 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
Who cannot join
- 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.
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- 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:
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cooper University Hospital
Camden, New Jersey, 08103
Valley Baptist Medical Center
Harlingen, Texas, 78550
Hoag Hospital - Irvine
Irvine, California, 92618
Loma Linda University Medical Center
Loma Linda, California, 92354
University of Miami Hospital
Miami, Florida, 33136
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
UC Davis Health System
Sacramento, California, 95817
LSU Health Sciences Center
Shreveport, Louisiana, 71103
About this study
This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
Read the 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.
- Conditions
- COVID-19
- Being tested
- Hemopurifier
- Keywords
- Hemopurifier, SARS-CoV-2, COVID-19, exosomes, plasmapheresis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopurifierDevice
Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hemopurifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Safety and tolerability
Measured: 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
Measured: Day 1 (Date of Consent) to Day 14
Incidence of serious adverse events
Safety and tolerability
Measured: Day 1 (Date of Consent) to Day 28
Secondary outcomes (13)
Length if Stay in ICU
Length of ICU stay in days
Measured: Day 1 (Date of Consent) to Day 28
In-hospital mortality
Number of deaths during hospitalization
Measured: Day 1 (Date of Consent) to Day 28
Days free of ventilatory dependency
Number of days without ventilatory support
Measured: Day 1 (Date of Consent) to Day 28
Vasopressor-free days
Number of days without vasopressor support
Measured: Day 1 (Date of Consent) to Day 28
Sequential Organ Failure Assessment (SOFA)
SOFA scoring system predicts the clinical outcome of critically ill patients.
Measured: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)
Acute Physiology and Chronic Health Evaluation (APACHE)
Measures the severity of disease for adult patients admitted to an ICU
Measured: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)
SARS CoV-2 RNA levels in plasma and nasopharyngeal samples
Measures viral exposure and levels of circulating virus
Measured: Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinued
Total lymphocyte count
Measurement of lymphocytes as there seems to be a correlation with the disease severity and lymphopenia.
Measured: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
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.
Measured: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
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.
Measured: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Troponin-T
Measurement of Troponin-T as high levels of troponin is found in COVID-19 patients.
Measured: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges
Measures the levels of SARS-CoV-2 RNA captured in the filter
Measured: Until study completion, 1 week or for the duration of ICU admission
Evaluation of viral particle load post-treatment Hemopurifier cartridges
Measures the levels of viral particles captured in the filter
Measured: Until study completion, 1 week or for the duration of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jun 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Why it stopped: Lack of eligible COVID-ICU patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aethlon Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven LaRosa, MD, Study director, Aethlon Medical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595903
- Sponsor's protocol ID
- AEMD-2020-02
- Status last verified
- Dec 2022
- First submitted
- 8 Oct 2020
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34692735Gooldy 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.
PubMed 35901224
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
- ClinicalTrials.gov ID
- NCT04595903
- Acronym / sponsor ID
- AEMD-2020-02
- Conditions
- COVID-19
- Keywords
- Hemopurifier, SARS-CoV-2, COVID-19, exosomes, plasmapheresis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible COVID-ICU patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Aethlon Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hemopurifier® | Experimental | Device: HemopurifierThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Laboratory diagnosis of COVID-19 infection with any of the following disease characteristics:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemopurifierHemopurifier treatments will be one four to six hour treatment session daily for up to 4 days | Device | Hemopurifier® |
Primary outcome
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
13 secondary outcomes
Length if Stay in ICU
Time frame: Day 1 (Date of Consent) to Day 28
In-hospital mortality
Time frame: Day 1 (Date of Consent) to Day 28
Days free of ventilatory dependency
Time frame: Day 1 (Date of Consent) to Day 28
Vasopressor-free days
Time frame: Day 1 (Date of Consent) to Day 28
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)
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)
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
Total lymphocyte count
Time frame: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
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)
D-dimer
Time frame: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
Troponin-T
Time frame: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)
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
Evaluation of viral particle load post-treatment Hemopurifier cartridges
Time frame: Until study completion, 1 week or for the duration of ICU admission
Results and safety
The study was stopped early (reason given: Lack of eligible COVID-ICU patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Background: PubMed 34692735Amundson 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.
- Background: PubMed 35901224Gooldy 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.
- WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven LaRosa, MD study director
Aethlon Medical Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemopurifier in people with COVID-19, run by Aethlon Medical Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of eligible COVID-ICU patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (time frame: Day 1 (Date of Consent) to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595903, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.