[The structure of post/long COVID fatigue syndrome. Prospects for correction].

AIM: To study the features of post-COVID asthenic syndrome and evaluate the effectiveness of the drug containing the succinic acid complex with trimethylhydrazinium in its treatment. MATERIALS AND METHODS: A prospective, multicenter, comparative, randomized, double-blind, placebo-controlled study of the efficacy of sequential therapy with BRAINMAX® included 160 patients with a history of coronavirus infection within 12 to 16 weeks (not more than 12 months). The study was conducted at 6 healthcare centers in different regions of the Russian Federation. Testing was performed on the following scores: VAS for headache score, MFI-20 asthenia score, PSQI test, FAS-10 fatigue score, DHI dizziness score, MoCA cognitive impairment score, Beck anxiety score, vegetative index of Kerdo. RESULTS: PSQI questionnaire showed significant improvement in sleep quality in the study group: by -2.5 points [-4; -1] (p<0.001); there was a more pronounced significant decrease in the MFI-20 score of -19.5 points [-27; -11] (p<0.001); a significant decrease in the FAS-10 fatigue score by -9 [-13.5; -4] points (p<0.001); DHI dizziness score showed a decrease by -6 [-12; 0] points in the BRAINMAX® group (p=0.001); the score of Beck anxiety and depression scale decreased by -5 [-11; -2] points (p<0.001). Multiple linear regression data showed a significant increase of 0.56 (p=0.02) in the MoCA score. CONCLUSION: Our study convincingly showed the effectiveness of therapy with BRAINMAX® in a wide range of symptoms in patients with the post-COVID syndrome.

[New opportunities for neuroprotective therapy of patients in the acute and early recovery period of ischemic stroke].

AIM: To evaluate the efficacy and safety of Brainmax in comparison with ethylmethylhydroxypyridine succinate and trimethylhydrazinium propionate in patients with ischemic stroke in the acute and early recovery period. MATERIALS AND METHODS: An open multicenter randomized study included 180 patients aged 1880 years (mean age 60.917.66 years, men 47.8%) with ischemic stroke in the acute and early recovery period (NIHSS from 3 to 15 points). Patients were randomized to receive Brainmax, ethylmethylhydroxypyridine succinate and trimethylhydrazinium propionate in an equal ratio (n=60). The drugs were administered intravenously for 10 days, followed by a transition to intramuscular injection for 14 days. Efficacy was assessed using the following scales: Modified Rankin Scale, NIHSS, Rivermead Mobility Index, Montreal Cognitive Assessment Scale (MoCA). Safety assessment was carried out according to the presence and structure of adverse events. RESULTS: The mean Modified Rankin Scale score for Visits 3 (day 10) and 5 (day 25) for the group treated with Brainmax was 2.410.85 and 1.440.91 points, for the group EMHPS 2.870.68 and 2.180.85 points, and for the group receiving trimethylhydrazinium propionate 2.870.50 and 2.550.70 points respectively, which reflects the best functional outcome in the Brainmax group (p0.05). Comparison of cognitive function indicators also showed statistically significant differences between the groups of drugs Brainmax and ethylmethylhydroxypyridine succinate. Evaluation according to the MoCA test showed that the use of Brainmax is 20% more effective in restoring cognitive functions (compared to monodrugs). CONCLUSION: The present study confirms the superiority of combination therapy with Brainmax over monotherapy with each of the components.

[Prospects and possibilities for the treatment of patients with long COVID-19 syndrome].

AIM: To study the efficacy and safety of a drug product based on the succinic acid complex with trimethylhydrazine used to treat patients with asthenic syndrome after a new coronavirus infection (COVID-19). MATERIALS AND METHODS: A prospective, multicenter, comparative, randomized, double-blind, placebo-controlled study of the safety and efficacy of sequential therapy with Brainmax® enrolled 160 patients 12-16 weeks after coronavirus infection (no more than 12 months). The study was conducted at 6 healthcare centers in different regions of the Russian Federation. At the enrollment, clinical and neurological examination and the following tests were performed: complete blood count, urinalysis, blood chemistry, coagulation test, pulse oximetry, electrocardiography, glomerular filtration rate calculation (according to Cockcroft-Gault formula) were performed. Also, the patients were assessed using the following tools: VAS headache rating scale, MFI-20 asthenia scale, PSQI index, FAS-10 fatigue assessment scale, Dizziness Handicap Inventory (DHI), MoCA-test for cognitive impairment assessment, Beck Anxiety Inventory, Kérdö Autonomic Index. RESULTS: The primary endpoint was the mean reduction in the MFI-20 asthenia scale score after the therapy (Visit 5, 41st day of therapy) compared to data from Visit 0 (beginning of therapy). A clinically significant advantage of the study drug versus the placebo was demonstrated, with a median absolute change in the MFI-20 score of -19.5 [-27; -11] points in the Brainmax® drug group and -3 [-7; 1] score in the placebo group (p<0.001). A significant sleep quality improvement according to the PSQI index was shown in the study group: by -2.5 [-4; -1] points versus no improvement in the placebo group (0 [-3; 0], p<0,001). Significant differences were also noted for the following secondary endpoints: PSQI sleep quality scale, FAS-10 fatigue assessment scale, DHI, and Beck Anxiety and Depression Inventory. There was also a decrease in patients' complaints of cognitive deterioration according to the CGI scale. CONCLUSION: Our study clearly demonstrated the efficacy and high safety profile of Brainmax® in a representative sample of patients with the post-COVID syndrome.