An Adaptive, Multicenter, Randomized, Open-label, Comparative Clinical Study to Assess Efficacy and Safety of Favipiravir in Hospitalized Patients With COVID-19

The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.

Start Date23 Apr 2020

Sponsor / Collaborator

Chromis Fiberoptics LLC

[+1]

100 Clinical Results associated with ChemRar High-Tech Center

0 Patents (Medical) associated with ChemRar High-Tech Center

Literatures (Medical) associated with ChemRar High-Tech Center

23 Apr 2024·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

Efficacy and safety of Aviandr in the treatment of anxiety in patients with adjustment disorders after COVID-19

Article

Author: Ivaschenko, A.V. ; Ivaschenko, A.A. ; Shamaeva, K.I. ; Antonova, E.A. ; Yakubova, E.V. ; Alpenidze, D.N. ; Drozdova, Yu.V. ; Tarakanova, A.S. ; Popova, V.B. ; Hlyabova, P.M. ; Kryzhanovsky, S.M. ; Rodyukova, I.S.

Objective. To investigate the efficacy and safety of Aviandr in the treatment of anxiety in patients with adjustment disorders after COVID-19. Material and methods. A multicenter prospective open-label study included 109 patients of both sexes aged 18 to 65 years (70 women, 39 men, average age — 41.4±13.18 years) with a leading complaint of anxiety (Hamilton scale score, HAM–A ≥18 — ≤24), which arose after acute coronavirus infections. Clinical manifestations had to meet the diagnostic criteria F43.2 ICD-10. The drug Aviander was prescribed 20 mg 2 times a day for 4 weeks. At the end of taking the drug, patients were monitored for another 1 week (a delayed follow-up visit). Psychopathological, statistical and parametric research methods were used using standardized HAM-A, Montgomery—Asberg scales (MADRS), visual analog asthenia scale (VASH-A), Sheehan Disability Scale (SDS), digital character substitution test (DSST), general clinical impression scale (CGI). Results. Data from 109\110 patients were analyzed to evaluate efficacy\safety. Aviandr was administered 20 mg 2 times daily for 4 weeks. Patients were followed for 1 week (delayed follow-up visit) at the end of treatment. Reducing the intensity of anxiety on the HAM-A scale was — 14.2±4.92 or 69.4±22.66% by the end of treatment. The response rate to therapy (responders are patients with a decrease in the total score on the HAM-A ≥50%) was 83.49%. Remission was achieved (sum of HAM-A scores ≤7) by the end of treatment 68.81% of patients, and 79.8% of patients at the follow-up visit. Significant changes were obtained on the MADRS, VAS-A, SDS and DSST scales. According CGI 45.9% of patients had «much improved» and 43.1% of patients had «very much improved» by the end of treatment; 58.7% of patients had «much improved» and of 33.9% patients had «very much improved» at the follow-up visit. 38 adverse events were reported in 27 (24.55%) patients during the study. A definite association with study drug was reported between 5 mild adverse events in 4 (3.64%) patients. No subjects withdrew from the study due to an adverse event. Positive dynamics (reduction of anxiety symptoms, decrease in asthenia) persisted after discontinuation of the study drug. No cases of withdrawal syndrome were observed. Conclusion: According to the results of the study, the anxiolytic, antidepressant, antiasthenic and pro-cognitive effects of Aviandr were observed. An increase in the social activity of patients was observed.

01 Nov 2021·Journal of psychiatric researchQ2 · MEDICINE

Safety and efficacy of aviandr in patients with generalized anxiety disorder: A multicenter, randomized, double-blind, placebo-controlled, dose-finding, pilot study

Q2 · MEDICINE

Article

Author: Bukhanovskaya, Olga A ; Gorchakov, Dmitriy S ; Lepilkina, Taissia A ; Beniashvily, Allan G ; Burminskiy, Denis S ; Rupchev, George E ; Kravchenko, Dmitry V ; Ivashchenko, Andrey A ; Mitkin, Oleg D ; Gluskina, Lubov Y ; Karapetian, Ruben N ; Vostokova, Natalia V ; Kasimova, Lala N ; Ivachtchenko, Alexandre V ; Morozova, Margarita A ; Merkulova, Elena A ; Egorova, Alina N ; Penchul, Nataliya A ; Potanin, Sergey S

Generalized anxiety disorder (GAD) is associated with an imbalance in the functioning of the stimulating neurotransmitter systems in human's brain. We studied the safety and therapeutic efficacy of aviandr, the new noradrenergic and specific serotonergic antidepressant, for GAD patients in the phase II, double-blind, placebo-controlled, randomized, multicenter, pilot trial at 17 clinical sites of the Russian Federation. 129 eligible patients were 18 years and older and met the criteria for GAD diagnosis. The patients were randomly assigned (1:1:1) to receive oral aviandr at daily dose of 40 mg (cohort 1, n = 41) or 60 mg (cohort 2, n = 43) or placebo (cohort 3, n = 43) for 8 weeks. The patients were assessed by the Hamilton anxiety scale (HAM-A), Hamilton Depression Scale (HAM-D), Clinical Global Impression Scale (CGI-S), Visual Analogue Scale and vital signs. At week 8, the decreases of the HAM-A score were achieved in 53∙7%, 47∙7% and 16∙3% in cohorts 1, 2 and 3, respectively. Changes of HAM-A, HAM-D, CGI-S, and CGI-I scores in aviandr-treated patients were superior to placebo (p < 0∙001). The psychic components of anxiety decreased on the first day, throughout the 8 weeks of treatment and on a follow-up week after aviandr discontinuation. Aviandr (40 mg daily dose) reduced drowsiness compared to baseline, was safe, well-tolerated and did not cause serious or severe adverse events or signs of withdrawal syndrome within one week after treatment completion. Aviandr at both 40 and 60 mg daily doses demonstrated therapeutic efficacy in GAD patients over placebo.

02 Aug 2021·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

AVIFAVIR for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial

Article

Author: Simakina, Elena N ; Azarova, Valeria N ; Blinow, Andrew A ; Tikhomolova, Elena G ; Papazova, Natalia A ; Sitdekov, Tagir A ; Ilin, Alexey P ; Ivashchenko, Andrey A ; Dmitriev, Kirill A ; Pavlikova, Elena P ; Yakubova, Elena V ; Gordeev, Ivan G ; Kravchenko, Dmitry V ; Ivachtchenko, Alexandre V ; Karapetian, Ruben N ; Smolyarchuk, Elena A ; Lomakin, Nikita V ; Vostokova, Natalia V ; Merkulova, Elena A ; Savchuk, Nikolay P ; Egorova, Alina N

Abstract:

In May 2020 the Russian Ministry of Health granted fast-track marketing authorization to RNA polymerase inhibitor AVIFAVIR (favipiravir) for the treatment of COVID-19 patients. In the pilot stage of Phase II/III clinical trial, AVIFAVIR enabled SARS-CoV-2 viral clearance in 62.5% of patients within 4 days, and was safe and well-tolerated.Clinical Trials Registration. NCT04434248.

News (Medical) associated with ChemRar High-Tech Center

09 Jul 2012

·www.biospace.com

Pfizer Inc. Licenses Diabetes Drug to Russia's SatRx

MOSCOW--(Marketwire - July 05, 2012) - ChemRar Hi-Tech Centre, the Russian pharmaceutical investment and R&D group, announced today that Pfizer granted exclusive development and marketing rights to SatRx for their DPP(1)-IVi compound, PF-00734200. SatRX, a ChemRar group company, is developing PF-00734200 for type 2 diabetes (T2D), one of the most burdensome chronic non-communicable diseases, which is fast reaching epidemic proportions throughout the world. Under the terms of the license, signed during the St. Petersburg Economic Forum on June 23, Pfizer granted exclusive worldwide rights (ex-China) development and commercialization of PF-00734200 as monotherapy or in combination with certain other. Pfizer will receive royalties and milestone payments based on commercialization activities. The agreement was developed as partial fulfillment of a Memorandum of Understanding reached in March 2011, under which Pfizer and ChemRar agreed to explore collaborations focused on research, development and commercialization of innovative compounds and vaccines to treat cardiometabolic, infectious and oncologic diseases in Russia and other countries. "We welcome this licensing agreement between SatRx and Pfizer. SatRx is going to register the new drug to the Russian market and will further establish breakthrough therapies for treating diabetes synergistically combining DPP-IVi with TGR5 agonists and other novel small molecule drug candidates in its R&D portfolio. ChemRar is committed to investing in development of innovative medicines, diagnostics and devices to control and treat type 2 and type 1 diabetes," confirmed Nikolay Savchuk, board member of ChemRar HTC. "We aspire to further expand our collaboration with Pfizer in the framework of the MOU we signed in 2011." "This licensing agreement with Pfizer provides SatRx with essential background for development of fully innovative tools to tune the metabolism of patients with T2D and obesity. Synergistic actions of DPP-IVi and proprietary new SatRx molecules active in the incretin metabolic cascade will provide significant therapeutic benefits and promises to increase patient compliance and quality of life," said Yulia Baybikova, General Manager of SatRx. The World Health Organization (WHO)(2) considers diabetes among the four most socially significant diseases, along with cardiovascular and respiratory diseases and cancers; responsible for 80% of deaths from non-communicable diseases worldwide. One of ten people in the world has diabetes, and T2D, formerly called non-insulin-dependent or adult-onset diabetes, comprises 90% of those cases. Based on Russian Endocrinology Association data(3), the prevalence of T2D is increasing in the Russian Federation in parallel with overall global trends. As of January 1, 2011 more than 3.3 million diabetes cases were registered in Russia, and 90% are T2D. Control-and-epidemiological studies by the State Federal Endocrinology Center from 2005-2010 indicate that the number of diabetic patients exceed the number of registered cases by 2-3 times. During the last 10 years the number of patients with diabetes in Russia has doubled. About ChemRar ChemRar High Tech Center is a unique group of biotech start up, R&D service and venture investment companies developing and commercializing innovative medicines for treatment of cardiometabolic and infectious diseases, oncology, and CNS pathologies in Russia and abroad. ChemRar Ventures is a Russian venture company, managing a diversified investment portfolio of biopharma, diagnostic and medical device companies developing treatments for unmet medical needs. SatRx is an R&D company focused on development in the area of diabetes and obesity. About SatRx SatRx is a Russian start-up company established in 2010 on the basis of ChemRar High Tech Center which aims to develop novel medicines and their synergistic combinations to treat diabetes, obesity and other metabolic diseases. (1) DPP4i (dipeptidyl peptidase) inhibitors provide a class of therapies that manage blood-glucose levels without the associated risk of hypoglycaemia that may be experienced with other diabetes medication. (2) The World health statistics 2012 report (3) I. Dedov and co-authors, Monograph "Consensus of experts of Russian association of endocrinologists on initiation of intensification of sugar-decreasing treatment for patients with type 2 diabetes", p.7, 2011 ChemRar Russia Elena Surina Email Contact +7 (926) 206-78-71 ChemRar US Olga Dmitrieva Email Contact (858) 794-48-60

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