AIM ImmunoTech Inc. (NYSE American: AIM) has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Ampligen as a potential infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD).

Amarex Clinical Research, LLC, an NSF International company, is managing the FDA submission and will manage the clinical trial.

The study will be a Phase 2, two-arm, randomized, double-blind, placebo- controlled, multicenter study to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD (also called long-haul COVID-19 ). Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks.

Read more in the AIM ImmunoTech newsroom.