AIM ImmunoTech Inc. announced it has enrolled and dosed the first subject in the company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions. This important study milestone follows on the heels of the company having recently opened multiple clinical study sites and having screened numerous subjects. Study screening is ongoing and AIM expects to dose additional new subjects in the coming weeks.

For more information about AMP-518, please visit ClinicalTrials.gov and reference identifier NCT05592418. The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in subjects experiencing the post-COVID condition of fatigue. The primary protocol planned outcome measure of the study is change from baseline to week 13 in PROMIS® Fatigue Score.

Other protocol planned study outcomes include: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to weeks 6 and 13 in distance traveled during a Six-Minute Walk Test; proportion of subjects that surpass 54 meters in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to weeks 6 and 13 in PROMIS® Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS® Sleep Disturbance Score. AMP-518 is expected to enroll approximately 80 subjects between the ages of 18 to 60 years across up to 10 centers in the United States. Subjects will be randomized 1:1 to receive twice weekly IV infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks.