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1.
Ter Arkh ; 94(11): 1285-1293, 2022 Dec 26.
Article in Russian | MEDLINE | ID: covidwho-20243601

ABSTRACT

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.


Subject(s)
COVID-19 , Post-Acute COVID-19 Syndrome , Humans , Asthenia/drug therapy , Asthenia/etiology , Prospective Studies , Fatigue , Double-Blind Method , Treatment Outcome
2.
Annals of Clinical and Experimental Neurology ; 14(2):62-69, 2020.
Article in Russian | Scopus | ID: covidwho-962021

ABSTRACT

The novel coronavirus pandemic presents one of the most significant challenges to modern healthcare, which involves all medical specialties. The current review encompasses the neurologic manifestations of COVID-19 - a yet to be defined problem. L. Mao et al. (2020) have found a third of COVID-19 patients to exhibit neurological symptoms the latter divided into three categories: Central nervous system involvement (vertigo, headache, altered consciousness, acute cerebrovascular pathology, ataxia, and seizures) in 24.8% of patients, peripheral nervous system involvement (smell and taste disorders, neuropathy) - 8.9%, and muscle pathology (muscle pain, associated with creatine kinase increase) - 10,7%. Cerebrovascular pathology in 221 patients, described by Y. Li et al. (2020) occurred in 5.9% of cases - the majority was comprised by ischemic stroke, and as a whole it was associated with a more severe disease course. T. Oxley et al. (2020) described 5 patients (less than 50 years of age) with a large-vessel stroke occurring as a result of COVID-19. It has been shown that meningoencephalitis may be linked to COVID-19 - this review addresses several described cases. A case series of Guillain-Barré syndrome n patients with SARS-CoV-2 infection is also described. Apart from that, it is well established that COVID-19 may lead to deterioration of concurrent somatic and (or) neurological diseases, worsening the prognosis. © 2020 Sovero Press Publishing House. All rights reserved.

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