RESUMO
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.
Assuntos
COVID-19 , Síndrome de COVID-19 Pós-Aguda , Humanos , Astenia/tratamento farmacológico , Astenia/etiologia , Estudos Prospectivos , Fadiga , Método Duplo-Cego , Resultado do TratamentoRESUMO
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.