An early clinical drug trial taking aim at long COVID fatigue has fallen short of a primary objective to restore normal energy-fueling cell function but still provided encouraging evidence that a favorable pathway exists for long haulers.
Long COVID or post-COVID is a condition where patients will recover from the acute infection caused by the SARS-CoV-2 virus but continue to suffer from lingering symptoms, such as heart palpitations, shortness of breath, muscle aches, and fatigue, which happens to be one of the most popular complaints.
One of the original focuses of the research conducted by the biotechnology company Axcella was to reinstate the full functional levels of mitochondria -- the powerhouse of the human cell -- in post-COVID patients. While these results were not statistically proven, Axcella's chief medical officer is confident the learnings provide a productive path for long haulers.
"We do believe we are improving mitochondrial function because if we look at the magnetic resonance technique that we were looking at, you can see correlations between the degree of improvement in that measure and the degree of improvement in fatigue," Chief Medical Officer Dr. Margaret Koziel told NBC New York in a recent interview.
The small study was conducted at the University of Oxford during a 28-day course consisting of 41 participating long haul patients -- 21 of them taking the drug and the rest were handed a placebo. The twice-daily therapy was given as a palatable, powdered four to six-ounce drink containing a total of 67.8 grams of the drug.
The members of the trial were all facing hindering fatigue at least 12 weeks out from the initial COVID-19 infection and underwent a series of six-minute walking tests to determine improvements.
After accessing fatigue, patients in the study reported feeling positive physical and mental developments deemed statistically significant. A couple of patients even noted physical fatigue scores returning back to normal.
Dr. Koziel added the Phase 2a trial helped the group understand the underlying biology of what Axcella set out to do on top of the clinical outcomes of patients generally bettering under the drug, which was exhibited as safe and well tolerated.
Axcella is a clinical-stage biotechnology company located in Cambridge, Mass. that generates new therapies to treat complex diseases. Last year, Axcella launched this randomized, double-blind, placebo-controlled Phase 2a trial testing out their drug, AXA1125.
To date, there are no medications specifically targeting chronic fatigue for post-COVID patients. Axcella's president and CEO Bill Hinshaw says the company is currently accelerating the next steps for new trials and meeting with regulators.
While estimates vary, the Centers for Disease Control and Prevention projected earlier this year that 1 in 5 adults will develop a long-term COVID condition. With more Americans contracting emerging variants, these numbers can continue to place various medical and financial stresses on patients desperately searching for answers.