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Amarex Clinical Research to Manage Phase 2 Clinical Study of a New Therapy for COVID-19 Long-Haulers
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 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.