MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) is encouraged by positive results from an open-label clinical study for the white-label version of its ArtemiC™ Support to assess its impact on patients suffering from Long-COVID.
Sponsored by Swiss Pharmacan AG, 60 COVID-vaccinated patients suffering from Long-COVID were observed in clinics across Spain when administered the study product twice a day for six weeks.
The study assessed post-COVID symptomatology and biological markers in regular blood tests and results indicate that the product may be effective in treating the symptoms of Long-COVID and other post-viral disease-related symptoms.
This study was conducted across public policlinics in Madrid, Barcelona, Castellon and Valencia, Spain.
Statistically significant improvement
The administered nutraceutical was shown to alleviate symptoms of Long-COVID unrelated to functional limitations, including pain, mental confusion, sleep disorders and inflammation.
The product was assessed through the following parameters, incorporating primary and secondary outcomes:
- Primary outcomes: functional status according to a Post-COVID Functional Scale (PCFS) one and six weeks after the initiation of the treatment, (ANNEX IV); patients completed a Quality of Life Questionnaire (ANNEX V).
- Secondary outcomes: post-COVID symptomatology according to a 10-point Likert scale one and six weeks after the initiation of the treatment.
Biological markers in the blood tests further proved a reduction of inflammation and enterohepatic involvement, as well as liver reactant proteins.
The efficacy of the nutraceutical can be measured by a quality of life, physical and cognitive symptoms improvement. As such, the following rationale is based on the biological markers measured in the blood tests:
- Increased levels of three acute phase reactant proteins (AGP, A2M, CRP) suggest subclinical coronavirus infection in the Gastro-intestinal (GI) tract, with mucosal permeability disorder and possible dysbiosis.
- It may lead to a comprehensive disruption of the brain-hepatopulmonary axis with impact on the liver, lungs, and blood-brain barrier, where it may have mild neurocognitive consequences and behavioural consequences.
- Although increased plasma AGP, A2M, and CRP may have beneficial effects in relation to the anti-microbial response, its inflammatory basis has one or more causes that need to be investigated, especially when they coincide in the patient with alterations in GI motility.
- In fact, this hepatic response suggests persistence of viral antigens in the GI tract, as well as alterations in the perivascular bacterial dysbiosis, with alterations in the permeability of the intestinal barrier and activation of neuro-immuno-inflammatory based mechanisms such as dyspepsia and irritable colon.
- Decrease of these markers can lead to the normalisation of the GI tract function and microbiome composition. This may lead to the improvement in the cognitive condition via brain gut axis and the physical symptoms are improved via brain hepatopulmonary axis.
Key results
A statistically significant improvement in pain symptoms, before and after the treatment with the nutraceutical.
Patients reported statistically significant improvement in the symptoms of Long-COVID which were not related to the functional limitations (cognition, mood, energy, sleep).
Patients reported statistically significant improvement in the ability to function in their daily life.
Statistically significant improvement in the following parameters relating to Long-COVID:
- Dyspnea: a significant difference was seen in the reported symptom intensity.
- Sleep disorders: a significant difference was seen in the reported symptom intensity.
- Headache: a significant difference was seen in the reported symptom intensity in each visit
- Depression: a significant difference was seen in the reported symptom intensity in each visit.
- Pain: a significant difference was seen in the reported symptom intensity in each visit
- Mobility intestinal problem: a significant difference was seen in reported symptom intensity in each visit.
- Mental confusion: a significant difference was seen in the reported symptom intensity.
“That the product could help to explain changes in the symptoms of Long-COVID patients is an extremely promising development for the company, with significant potential commercial developments we hope to explore further through future studies.”