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

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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.

About the authors

Marine M. Tanashyan

Scientific Center of Neurology

Email: angioneurology0@gmail.com
ORCID iD: 0000-0002-5883-8119

чл.-кор. РАН, д-р мед. наук, проф., зам. дир. по научной работе, рук. 1-го неврологического отд-ния

Russian Federation, Moscow

Anton A. Raskurazhev

Scientific Center of Neurology

Email: angioneurology0@gmail.com
ORCID iD: 0000-0003-0522-767X

канд. мед. наук, ст. науч. сотр., врач-невролог 1-го неврологического отд-ния

Russian Federation, Moscow

Polina I. Kuznetsova

Scientific Center of Neurology

Author for correspondence.
Email: angioneurology0@gmail.com
ORCID iD: 0000-0002-4626-6520

канд. мед. наук, науч. сотр., врач-невролог 1-го неврологического отд-ния

Russian Federation, Moscow

Petr A. Bely

Yevdokimov Moscow State University of Medicine and Dentistry

Email: angioneurology0@gmail.com
ORCID iD: 0000-0001-5998-4874

канд. мед. наук, ст. лаборант каф. пропедевтики внутренних болезней и гастроэнтерологии

Russian Federation, Moscow

Kira Ia. Zaslavskaya

Ogarev National Research Mordovia State University

Email: angioneurology0@gmail.com
ORCID iD: 0000-0002-7348-9412

ассистент каф. биологической и фармацевтической химии с курсом организации и управления фармацией Медицинского института

Russian Federation, Saransk

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Supplementary files

Supplementary Files
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2. Fig. 1. Study design.

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3. Fig. 2. The study flow-chart (according CONSORT guidelines).

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4. Fig. 3. MFI-20 score (%) change at the end of therapy. The horizontal dashed lines are drawn for clarity at the values of 20% and -20% respectively.

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5. Fig. 4. MFI-20 score change at the end of therapy.

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6. Fig. 5. DHI total score change.

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7. Fig. 6. Beck Anxiety and Depression Inventory total score change.

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