On Oct. 6, 2020, AIM ImmunoTech announced that it had received Institutional Review Board approval for the expansion of the AMP-511 Expanded Access Program clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with AIM’s flagship pipeline drug Ampligen.

These patients – commonly referred to as Post-COVID-19 Chronic Fatigue (PCCF) / “Long Haulers” because of the persistence of their symptoms – will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. Up to 20 of the 100 active participants can be Long Haulers, according to the new trial protocol amendment. AIM is currently preparing the IRB-approved protocol for submission to the U.S. Food and Drug Administration (“FDA”).

Many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors met the CDC criteria for chronic fatigue syndrome. There is now increasing evidence that patients with COVID-19 – the disease caused by SARS-CoV-2 – can develop a similar, ME/CFS-like illness. AIM CEO Thomas K. Equels states, “With millions of U.S. cases of COVID-19 already on record we can expect a tidal wave of new U.S. cases of COVID-19 sufferers who will exhibit serious chronic fatigue-like symptoms. In addition, unpublished data from AIM indicates that ME/CFS patients respond better to Ampligen the earlier they receive the drug, so enrolling ‘Long Haulers’ earlier in their diagnosis could potentially benefit these patients while also providing valuable information for all ME/CFS patients.”