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

Finnigan, Lucy E.M.; Cassar, Mark Philip; Koziel, Margaret James; Pradines, Joël; Lamlum, Hanan; Azer, Karim; Kirby, Dan; Montgomery, H. E.; Neubauer, Stefan; Valkovič, Ladislav; Raman, Betty

doi:10.1016/j.eclinm.2023.101946

Cited by 23 publications

(10 citation statements)

References 31 publications

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“…Treatment modalities depend on the specific phenotype of long COVID. Lifestyle management, including pacing, energy optimization, and regular rests, along with low-dose naltrexone, have shown good efficacy among patients with neurological phenotypes, such as myalgic encephalomyelitis/chronic fatigue syndrome [ 1 , 55 ].…”

Section: Discussionmentioning

confidence: 99%

“…AXA1125, a novel metabolic modulator composed of 5 amino acids and N -acetylcysteine, has demonstrated the ability to reverse mitochondrial dysfunction, improve energetic efficiency through increased fatty acid oxidation, restore cellular homeostasis, and reduce inflammation. In patients with fatigue-predominant long COVID, oral administration of AXA1125 twice daily for 4 weeks resulted in greater symptomatic improvement compared to a placebo [ 55 ]. Coenzyme Q10, D-ribose, and low-dose aripiprazole may also be useful in managing fatigue in some patients [ 1 ].…”

Section: Discussionmentioning

confidence: 99%

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Autoimmunity and long COVID in children

Boyarchuk,

Volianska

2024

Reumatologia

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Numerous hypotheses regarding the pathogenetic mechanisms of long COVID have been proposed. Immune dysregulation and autoimmunity are among the leading hypotheses. In this article, we pre-sent two clinical cases of long COVID. The first case demonstrates the phenotype of long COVID with pain and musculoskeletal symptoms, which is often associated with autoimmunity and mimics systemic connective tissue diseases. In the second case, a high titer of antinuclear antibodies was observed after SARS-CoV-2 infection, but the clinical symptoms were limited to fever and headache. Only a comprehensive evaluation of clinical symptoms and thorough objective examination can con-firm or exclude autoimmune diseases after a previous SARS-CoV-2 infection. A systematic search in the PubMed Medline database was carried out for studies focusing on immune dysregulation, auto-immunity, and its association with the clinical phenotype of long COVID. The question of the role of autoimmunity in the development of long COVID and the management approaches are discussed.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Autoimmunity and long COVID in children

Boyarchuk,

Volianska

2024

Reumatologia

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“… 23 24 Further validation of metabolic modulation to improve the symptom burden of long COVID is required. 25 …”

Section: Discussionmentioning

confidence: 99%

Long COVID and cardiovascular disease: a prospective cohort study

Lawson,

Moss,

Arnold

et al. 2024

Open Heart

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BackgroundPre-existing cardiovascular disease (CVD) or cardiovascular risk factors have been associated with an increased risk of complications following hospitalisation with COVID-19, but their impact on the rate of recovery following discharge is not known.ObjectivesTo determine whether the rate of patient-perceived recovery following hospitalisation with COVID-19 was affected by the presence of CVD or cardiovascular risk factors.MethodsIn a multicentre prospective cohort study, patients were recruited following discharge from the hospital with COVID-19 undertaking two comprehensive assessments at 5 months and 12 months. Patients were stratified by the presence of either CVD or cardiovascular risk factors prior to hospitalisation with COVID-19 and compared with controls with neither. Full recovery was determined by the response to a patient-perceived evaluation of full recovery from COVID-19 in the context of physical, physiological and cognitive determinants of health.ResultsFrom a total population of 2545 patients (38.8% women), 472 (18.5%) and 1355 (53.2%) had CVD or cardiovascular risk factors, respectively. Compared with controls (n=718), patients with CVD and cardiovascular risk factors were older and more likely to have had severe COVID-19. Full recovery was significantly lower at 12 months in patients with CVD (adjusted OR (aOR) 0.62, 95% CI 0.43 to 0.89) and cardiovascular risk factors (aOR 0.66, 95% CI 0.50 to 0.86).ConclusionPatients with CVD or cardiovascular risk factors had a delayed recovery at 12 months following hospitalisation with COVID-19. Targeted interventions to reduce the impact of COVID-19 in patients with cardiovascular disease remain an unmet need.Trail registration numberISRCTN10980107.

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“…Trials of potential treatments for patients with persistent health problems beyond the acute COVID-19 illness are being undertaken, although are few in number. In a phase 2 placebo-controlled trial, 4 weeks of AXA1125 (an endogenous metabolic modulator comprised of five amino acids and N-acetylcysteine) improved fatigue scores in patients with persistent fatigue at least 12 weeks after COVID-19 [35]. The Stimulate-ICP (Symptoms, Trajectory, Inequalities and Management: Understanding Long-COVID to Address and Transform Existing Integrated Care Pathways) study will investigate the effect of antihistamine (famotidine/loratidine), anticoagulation (rivaroxaban), and anti-inflammatory (colchicine) medications on Long Covid recovery, in addition to interventions such as rehabilitation strategies [36].…”

Section: Discussionmentioning

confidence: 99%

One year health outcomes associated with systemic corticosteroids for COVID-19: a longitudinal cohort study

Leavy,

Russell,

Harrison

et al. 2023

Preprint

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BackgroundIn patients with COVID-19 requiring supplemental oxygen, dexamethasone reduces acute severity and improves survival, but longer-term effects are unknown. We hypothesised that systemic corticosteroid administration during acute COVID-19 would be associated with improved health-related quality of life (HRQoL) one year after discharge.MethodsAdults admitted to hospital between February 2020 and March 2021 for COVID-19 and meeting current guideline recommendations for dexamethasone treatment were included using two prospective UK cohort studies. HRQoL, assessed by EQ-5D-5L utility index, pre-hospital and one year after discharge were compared between those receiving corticosteroids or not after propensity weighting for treatment. Secondary outcomes included patient reported recovery, physical and mental health status, and measures of organ impairment. Sensitivity analyses were undertaken to account for survival and selection bias.FindingsIn 1,888 participants included in the primary analysis, 1,149 received corticosteroids. There was no between-group difference in EQ-5D-5L utility index at one year (mean difference 0.004, 95% CI: -0.026 to 0.034,p= 0.77). A similar reduction in EQ-5D-5L was seen at one year between corticosteroid exposed and non-exposed groups (mean (SD) change -0.12 (0.22) vs -0.11 (0.22),p= 0.32). Overall, there were no differences in secondary outcome measures. After sensitivity analyses modelled using a larger cohort of 109,318 patients admitted to hospital with COVID-19, EQ-5D-5L utility index at one year remained similar between the two groups.InterpretationSystemic corticosteroids for acute COVID-19 have no impact on the large reduction in HRQoL one year after hospital discharge. Treatments to address this are urgently needed.Take home messageSystemic corticosteroids given for acute COVID-19 do not affect health-related quality of life or other patient reported outcomes, physical and mental health outcomes, and organ function one year after hospital discharge

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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

Cited by 23 publications

References 31 publications

Autoimmunity and long COVID in children

Autoimmunity and long COVID in children

Long COVID and cardiovascular disease: a prospective cohort study

One year health outcomes associated with systemic corticosteroids for COVID-19: a longitudinal cohort study

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