After rejecting the drug as a treatment for ME/CFS more than a decade ago, the U.S. Food and Drug Administration (FDA) recently approved a phase two clinical trial for Ampligen as a Long COVID treatment. Good results could open the door to expedited approval and use.*

What is Ampligen?

Ampiglen—also known as atvogen, or its generic name, rintatolimod—is an antiviral medication developed by AIM ImmunoTech that stimulates various parts of the immune system, promoting immune cell production and initiating killer cell activity. 

Clinical trials of Ampligen have been going on since the 1980s for treating various conditions, such as chronic fatigue syndrome (ME/CFS), the Ebola virus, and HIV/AIDS. Despite negative side effects, previous studies suggest that Ampligen can help improve cognitive function, the ability to exercise, and overall health in people with ME/CFS. It’s also been shown to slow the activity of HHV-6, a virus linked to the development of ME/CFS.

Despite this evidence, however, the FDA has continued to withhold its approval of Ampligen for treating ME/CFS, citing insufficient evidence of both effectiveness and safety. The drug is currently not approved for any use in the U.S. or the European Union.

Another chance for approval

Severe and widespread fallout from the COVID-19 pandemic, however, is giving Ampligen a second chance. On October 12, 2022, the FDA approved a phase two clinical trial of the drug for treating Long COVID. Researchers will mainly focus on Ampligen’s ability to fatigue, brain fog, and sleep disturbances in COVID long-haulers. Study results may be available as soon as 2023.

What does this mean for COVID long-haulers?

If the trials produce good results, it could possibly expedite approval for Ampligen’s use, potentially even including an Emergency Use Authorization from the FDA, the special approval used to speed up COVID-19 vaccine administration. 

If Ampligen is approved, it could also help people suffering from ME/CFS, since the condition shares such symptoms as brain fog, fatigue, and post-exertional malaise with Long COVID.

Solve M.E.’s president and CEO, Oved Amitay, says, “To address the needs of Long COVID patients, it is critical that we apply existing knowledge, such as studies did previously in ME/CFS. This study is an important step in addressing the needs of all individuals who face debilitating post-infection symptoms, including those with ME/CFS.”

*Breaking News: FDA clears Ampligen to start a clinical trial in Long Covid. (2022, October 12). Solve ME/CFS Initiative. Retrieved October 18, 2022, from https://solvecfs.org/breaking-news-fda-clears-ampligen-to-start-a-clinical-trial-in-long-covid/