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Virus Therapy

Hemopurifier for COVID-19

N/A

Waitlist Available

Led By Usman Shah, MD

Research Sponsored by Aethlon Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (date of consent) to day 28

Awards & highlights

Study Summary

This trial is testing if the Hemopurifier can help treat people with COVID-19.

Eligible Conditions

COVID-19
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (date of consent) to day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (date of consent) to day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (date of consent) to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of device related adverse events

Incidence of serious adverse events

Incidence of treatment emergent adverse events

Secondary outcome measures

Acute Physiology and Chronic Health Evaluation (APACHE)

C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests

D-dimer

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hemopurifier®Experimental Treatment1 Intervention

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.

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Who is running the clinical trial?

Aethlon Medical Inc.Lead Sponsor

2 Previous Clinical Trials

10 Total Patients Enrolled

Usman Shah, MDPrincipal InvestigatorHoag Memorial Hospital Presbyterian

Steven LaRosa, MDStudy DirectorAethlon Medical Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives has this medical trial been established to realize?

"Aethlon Medical Inc., the trial sponsor, has reported that the primary outcome they are measuring over a Day 1 (Date of Consent) to Day 28 period is adverse events arising from treatment. Secondary outcomes include APACHE scores for adult ICU patients, D-dimer levels as prognostic markers of in-hospital mortality and SARS CoV-2 viral exposure measurements in plasma and nasopharyngeal samples."

Answered by AI

Are recruitment opportunities available at this time for the clinical trial?

"Clinicaltrials.gov indicates that this research endeavour is currently seeking participants; the first post was on June 12th 2022 and the last update occurred July 18th 2022."

Answered by AI

How many research centers are executing this trial?

"The current roster of 9 participating sites is spread across Harlingen, Newport Beach and Loma Linda amongst other cities. To make the trial as convenient a process as possible for enrolled participants please select the closest clinic to you."

Answered by AI

What is the magnitude of enrollees for this investigation?

"To fulfill the study's requirements, 40 eligible patients must be enrolled. The trial is sponsored by Aethlon Medical Inc., and will take place at Valley Baptist Medical Center in Harlingen, Texas and Hoag Memorial Hospital Presbyterian in Newport Beach, California."

Answered by AI

Recent research and studies

Blood PurificationJournal

Extracorporeal Virus Elimination for the Treatment of Severe Ebola Virus Disease - First Experience with Lectin Affinity Plasmapheresis

Büttner, Stefan, Benjamin Koch, Olga Dolnik, Markus Eickmann, Tilo Freiwald, Sarah Rudolf, Jürgen Engel, Stephan Becker, Claudio Ronco, and Helmut Geiger. 2014. “Extracorporeal Virus Elimination for the Treatment of Severe Ebola Virus Disease - First Experience with Lectin Affinity Plasmapheresis”. Blood Purification. S. Karger AG. doi:10.1159/000375229.

Frontiers in MedicineJournal

Removal of COVID-19 Spike Protein, Whole Virus, Exosomes, and Exosomal Micrornas by the Hemopurifier® Lectin-affinity Cartridge in Critically Ill Patients with COVID-19 Infection

Amundson, Dennis E., Usman S. Shah, Rosalia de Necochea-Campion, Michael Jacobs, Steven P. LaRosa, and Charles J. Fisher Jr.. 2021. “Removal of COVID-19 Spike Protein, Whole Virus, Exosomes, and Exosomal Micrornas by the Hemopurifier® Lectin-affinity Cartridge in Critically Ill Patients with COVID-19 Infection”. Frontiers in Medicine. Frontiers Media SA. doi:10.3389/fmed.2021.744141.

Plos OneJournal

Removal of Clinically Relevant Sars-cov-2 Variants by an Affinity Resin Containing Galanthus Nivalis Agglutinin

Gooldy, Melanie, Christelle M. Roux, Steven P. LaRosa, Nicole Spaulding, and Charles J. Fisher. 2022. “Removal of Clinically Relevant Sars-cov-2 Variants by an Affinity Resin Containing Galanthus Nivalis Agglutinin”. Edited by Hana Maria Dobrovolny. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0272377.

clinicaltrials.govStudy