AIM ImmunoTech has dosed its first Covid-19 ‘long hauler’ patient in the active AMP-511 Expanded Access Program (EAP) with the Ampligen (rintatolimod) drug for the treatment of post-Covid-19 infection chronic fatigue-like symptoms.
The company noted that more patients are being enrolled in the trial, which is believed to be the first one to treat a patient with Covid-19-induced chronic fatigue-like symptoms.
As per the Ampligen EAP protocol, at a time, it is authorised to enrol up to 100 active Chronic Fatigue Syndrome trial subjects, 20 of whom could be long haulers.
All participants will be given the same Ampligen therapy in the trial.
AIM CEO Thomas Equels said: “The development of an effective therapy for Covid-19-induced chronic fatigue is a critical unmet public health need.
“Although AMP-511 is not a controlled trial, patients in this AIM-sponsored study are monitored closely and it may be possible to report important observations as early as May.”
Last year, AIM had announced the expansion of the Ampligen-involved myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) EAP to add in patients who were previously infected with Covid-19 and whose symptom persistence has led to the group called ‘long haulers’.
According to studies, Covid-19 recovered patients can have persistence of symptoms.
Furthermore, many of the first SARS-CoV-1 epidemic survivors in 2003 had classic chronic fatigue-like symptoms after they recover from acute disease.
Hunter-Hopkins Center EAP investigator Dr Charles Lapp said: “Hunter-Hopkins Center is excited to have started Ampligen therapy for the first time on a Long Hauler with CFS-like symptoms.
“We believe that Long Haulers experience a post-viral fatigue syndrome similar to many persons with Chronic Fatigue Syndrome, and starting treatment early and aggressively should enhance the potential to improve their symptoms and outcomes.”
In July last year, AIM signed a clinical trial agreement (CTA) with Roswell Park Comprehensive Cancer Center for a Phase I/IIa clinical trial of Ampligen plus interferon alfa-2b for treating Covid-19 patients with cancer.