An interventional study of Hemopurifier in COVID-19, sponsored by Aethlon Medical Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Aethlon Medical Inc. · Not applicable, Interventional, and Treatment
This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
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.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 1 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Aethlon Medical Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
lung infiltrates >50% within 24 to 48 hours; iii. Life-threatening disease, defined as:
Exclusion Criteria:
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
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
Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days
Incidence of treatment emergent adverse events
Safety and tolerability
Time frame: 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
Time frame: Day 1 (Date of Consent) to Day 14
Incidence of serious adverse events
Safety and tolerability
Time frame: Day 1 (Date of Consent) to Day 28
Length if Stay in ICU
Length of ICU stay in days
Time frame: Day 1 (Date of Consent) to Day 28
In-hospital mortality
Number of deaths during hospitalization
Time frame: Day 1 (Date of Consent) to Day 28
Days free of ventilatory dependency
Number of days without ventilatory support
Time frame: Day 1 (Date of Consent) to Day 28
Vasopressor-free days
Number of days without vasopressor support
Time frame: Day 1 (Date of Consent) to Day 28
Sequential Organ Failure Assessment (SOFA)
SOFA scoring system predicts the clinical outcome of critically ill patients.
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)
Measures the severity of disease for adult patients admitted to an ICU
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
Measures viral exposure and levels of circulating virus
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
Measures the levels of SARS-CoV-2 RNA captured in the filter
Time frame: 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
Time frame: Until study completion, 1 week or for the duration of ICU admission
Plan to share: No
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Aethlon Medical Inc.