- Aethlon Medical ( NASDAQ: AEMD ) on Monday said the U.S. FDA had approved a change in the protocol of the company's ongoing trial evaluating its blood filtration system to treat patients with severe COVID-19.
- AEMD said the change in protocol eliminates the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening.
- The trial is currently evaluating the safety and efficacy of AEMD's Aethlon Hemopurifier product. The trial is designed to enroll up to 40 severe COVID-19 patients.
- "We anticipate that this protocol amendment will enable us to enroll patients at an increased rate now that dialysis treatment is no longer a study requirement", said AEMD CEO Charles Fisher, Jr.
For further details see:
FDA approves protocol change in Aethlon's trial of its purifier to treat severe COVID