Aethlon Medical has won a nod from FDA for a protocol amendment to its Hemopurifier COVID-19 Study.

The San Diego, CA-based company said the newly-approved protocol amendment eliminates the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening.

The Aethlon Hemopurifier is a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. Aethlon is currently evaluating the safety and feasibility of the Hemopurifier in an active Early Feasibility Study (EFS), analogous to a Phase 1 clinical trial for a drug or biologic, which is designed to enroll up to 40 severe COVID-19 patients. Aethlon recently announced that the first patient has completed Hemopurifier treatment in the trial and that there are nine hospitals actively screening patients.

"We have learned from our study sites during screening, from data presentations and from thought leaders in the field that the incidence of COVID-19-induced kidney injury, resulting in the need for kidney replacement therapy (KRT), has decreased dramatically during the course of the pandemic," said Steven LaRosa, M.D., CMO of Aethlon Medical. "As such, we worked closely with the FDA to construct updated wording in the protocol and informed consent that allows patients to participate in the study who do not already require KRT yet still protects patient safety."