A potential treatment for fatigue for people with long COVID shows promise after a phase 2 clinical trial, British researchers have reported.
Researchers from the University of Oxford say individuals who received AXA1125 in a randomised double-blind placebo-controlled trial were significantly less tired than those who received the placebo.
Writing in Lancet eClinical Medicine, the researchers say their findings in what one of the first trials of its type into a potential long COVID treatment is “really positive news”.
AXA1125 was tested because previous data from US pharmaceutical company Axcella Therapeutics, which manufactures the treatment, showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation.
Of the 41 study participants, half had the investigational treatment while the other half had a placebo. On average, they had experienced fatigue for about 18 months prior to entering the study.
The researchers also tracked mitochondrial health in the patients’ muscles before and after they took the medication, by using magnetic resonance spectroscopy scans of the patients’ calf muscles as they bent and straightened their leg against the mild resistance from an exercise band.
Although there was no overall difference in mitochondrial health between patients who received the treatment compared to those who took the placebo, those in the treatment cohort reported significantly improved fatigue levels.
Those who reported an improvement in fatigue also had improved mitochondrial health and walked further compared to those without.
Principal Investigator, associate professor Betty Raman from the Radcliffe Department of Medicine at Oxford University, said: “The reduction in patients’ own reports of fatigue is really positive news, and we hope that further work will help us understand the underlying processes behind this improvement too.
“There is still some way to go in treating all patients with long COVID – our results focus specifically on fatigue, rather than the breathlessness and cardiovascular issues that other long COVID patients have reported.
“We also selected patients who had clear signs of mitochondrial function being disturbed – effects of the medication on other symptoms remains to be evaluated in future studies.”
Study author Dr Margaret Koziel, chief medical officer of Axcella, which funded the research, added: “We are encouraged by these results, and hope that a treatment for people who suffer from long COVID fatigue may be in sight.”
Finnigan LEM, Cassar MP, Koziel MJ et al. Efficacy and tolerability of an endogenous metabolic modulator (AXA1125) in fatigue-predominant long COVID: a single-centre, double-blind, randomised controlled phase 2a pilot study. Lancet eClinical Medicine 14 April 2023
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