This is one of the first randomized double-blind placebo controlled trials of a potential long COVID treatment – AXA1125. Randomised control trials are considered to be gold standard for testing potential treatments for an illness.
People living with long COVID in the trial who received AXA1125 had a significant improvement in fatigue compared to those who received a placebo (material matched in appearance and taste to the investigational treatment). The study was double-blind, that is, neither the patients nor the researchers working with the patients knew which patients had the treatment and which patients had a placebo.
AXA1125 was tested in long COVID fatigue as previous data from Axcella showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests that the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation. AXA1125 may improve energy generation and reduce the amount of inflammation in the body.
Of the 41 patients taking part in this study, half had the investigational treatment (an orange-flavoured powder dissolved in water) twice daily for four weeks, while the other half had a placebo. On average, patients had symptoms of fatigue for about 18 months prior to entering the study. All the patients who started the study completed it, and none reported serious adverse effects of either the treatment or the placebo.