Clinical efficacy of umifenovir in influenza and ARVI (study ARBITR)

Abstract

In spite of vaccination was recommended by the World Health Organization, the main strategy of influenza is antiviral drugs treatment, one of which is umifenovir. Aim. The aim of the study is to obtain additional data on safety and therapeutic efficacy of the antiviral drug Arbidol (umifenovir) in patients with a diagnosis of influenza and common cold. Materials and methods. Double-blind, randomized, placebo-controlled clinical study investigating efficacy and safety of Arbidol (umifenovir) in Treatment and Prophylaxis of Influenza and Common Cold (ARBITR) IV phase started in November 2011 and completed in April 2016 on the basis of 15 research centers in various regions of the Russian Federation. A total of 359 patients, aged 18 to 65 years with influenza or acute respiratory tract infection, of no more than 36 hours' duration were enrolled in the study. Patients were randomized into two groups: a group of patients (therapy group) treated by Arbidol (umifenovir) at a dosage of 800 mg/day (2 capsules) for 5 days (n=181), and a group of patients receiving placebo 4 times a day for 5 days (n=178). The primary outcome measures of the study were the duration of clinical illness among patients with common cold and influenza/ARVI, the duration and severity of the main symptoms. Number of clinical complications associated with influenza and common cold was assessed as a secondary outcome. Safety was assessed by analyzing number of adverse events that are probably or definitely related to Arbidol, assessing vital signs, examining the physical condition of patients and general clinical laboratory parameters. Results. In the group treated by umifenovir, the number of full recover patients on the 4th day from the disease onset were significantly differed from the number of such cases in the placebo group. The number of cases of complete recovery after 96 hours was 98 patients (54.1%) and 77 (43.3%), p

Molecular Investigation of SARS–CoV-2 Proteins and Their Interactions with Antiviral Drugs

“…One of the antiviral drugs tested against SARS-CoV-2 envelope protein is Enfuvirtide, an HIV fusion inhibitor used in combination therapy for the treatment of HIV-1 infection [37]. The second molecule tested is Umifenovir, an antiviral agent with activity against Influenza A-and B-viruses [38]. The last one is Pleconaril [39], used for prevention of asthma exacerbations and common cold symptoms in asthmatic subjects exposed to respiratory infections; Pleconaril is orally bioavailable and active against Picornaviridae viruses.…”

Antioxidant Potential of Antiviral Drug Umifenovir

“…The clinical trials of Umifenovir were performed in the former USSR during 1980-1995 and post-marketing phase IV trial in 2011-2017 influenza seasons. In a double-blind, randomized, placebo-controlled clinical study ARBITR (ClinicalTrials.gov Identifier: NCT01651663) investigating the efficacy and safety of Arbidol among 359 adults that was carried out in Russia, Umifenovir (800 mg daily for five days) significantly (p < 0.05) reduced the duration of fever (68 h in Umifenovir group and 75.3 in placebo group), muscle pain (52.2 vs 59.1), and weakness (76.9 vs 88.9) in Umifenovir-treated group when compared to control untreated patients, and reduced the risk of complications, namely influenza with low respiratory tract infections (0% vs 3.36%) [24]. Post-marketing surveillance of the efficiently of Umifenovir in clinical use was made by retrospective analyzed of 5287 patients with influenza and other ARVI in 88 hospitals from 50 regions of the Russian Federation.…”

Favipiravir versus Arbidol for COVID-19: A Randomized Clinical Trial

“…Because both viruses are RNA virus depending on RNA-dependent RNA polymerase (RdRp) to replicate, the RdRp inhibitor Arbidol (common name for Umifenovir) approved for influenza in Russia and China has been proposed as a standard care option for COVID-19, mainly based on its mechanism-of-action (MoA) and its effects in treating influenza-associated pneumonia. [5][6][7] Favipiravir, an antiviral drug targeting RdRP, 8 approved in Japan for influenza, has an IC50 of 0.013-0.48 ug/ml for influenza A. Comparing this with the EC50 of 2.7-13.8 ug/ml of Arbidol, 9 we consider Favipiravir might serve as a potential candidate to treat COVID-19.…”