More than 23 000 patients including 6 500 children were enrolled into the clinical studies of ARBIDOL.
Results of clinical studies and perennial experience of ARBIDOL administration in the clinical practice proved that medicinal product had a favourable safety profile.
ARBITR is the double blind, randomized, placebo controlled multicentre clinical study of medicinal product ARBIDOL in the treatment and prevention of influenza and other ARVIs.
Large-scale pharmaco-epidemiological studies EGIDA-1.
Five thousand two hundred and eighty-seven (5287) patients with the age from 1 month to 89 years old were admitted to the hospitals with the diagnosis ARVI/influenza during the periods of 2010-2011 and 2014-2015. Study results proved efficacy of antiviral therapy with Umifenovir (ARBIDOL) against ARVI, especially in the risk groups, which was manifested by the reduction of disease severity and symptoms duration as well as decrease of complications development frequency.
At the end of December 2016, the group of famous American scientists from the leading scientific centre the Scripps Research Institute, La Jolla, San Diego, California obtained the data proving the mechanism of direct antiviral action of Umifenovir (ARBIDOL). It was previously shown that the target of the original Russian antiviral medicine ARBIDOL was the influenza virus surface protein HA (hemagglutinin). [Leneva I.A, Rupert J. Russell, Yury S. Boriskin, Alan J. Hay. Characteristics of Arbidol-Resistant Mutants of Influenza Virus: Implications for the Mechanism of Anti-Influenza Action of Arbidol. Antiviral Research 81 (2009), pp. 132-140].
Obtained information allowed classifying ARBIDOL as the first anti-influenza medicinal product with the directed action at the influenza virus hemagglutinin.
18 Feb 2020 Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 6) promulgated by the Chinese government
China’s National Health Commission issued its sixth national treatment and diagnosis plan for the novel coronavirus. The antiviral drug Arbidol was added to the treatment plan.
18 Mar 2020 Handbook of COVID-19 Prevention and Treatment
The Jack Ma Foundation and Alibaba Foundation announced the publication and distribution of a handbook detailing learnings and best practices from the First Affiliated Hospital, Zhejiang University School of Medicine, for treating Covid-19 patients. Handbook was translated from Chinese into 16 languages.
27 Feb 2020 Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods Canrong Wu et al. Acta Pharmaceutica Sinica B
Arbidol is a broad-spectrum anti-viral drug, mainly for the treatment of upper respiratory tract infections caused by influenza A and B viruses, etc. In recent years, many studies have proven its effectiveness against both SARS-CoV and MERS-CoV. Arbidol hydrochloride can block virus replication by inhibiting the fusion of the lipid membrane of the virus with the host cells. Compared with the untreated control group, arbidol can effectively inhibit coronavirus up to 60 times at a concentration of 10–30 μmol/L, and significantly inhibit the virus's pathological effects on cells.
13 Apr 2020 Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19).
A Review James M. Sanders, Marguerite L. Monogue et al. JAMA. Published online
Umifenovir (also known as Arbidol) is a more promising repurposed antiviral agent with a unique mechanism of action targeting the S protein/ACE2 interaction and inhibiting membrane fusion of the viral envelope. The agent is currently approved in Russia and China for the treatment and prophylaxis of influenza and is of increasing interest for treating COVID-19 based on in vitro data suggesting activity against SARS. The current dose of 200 mg orally every 8 hours for influenza is being studied for COVID-19 treatment (NCT04260594).
28 Apr 2020 Arbidol: A potential antiviral drug for the treatment of SARS-CoV-2 by blocking the trimerization of viral spike glycoprotein? Vankadari N, International Journal of Antimicrobial Agents (2020)
Naveen Vankadari, Research Fellow of Monash University in Melbourne, Australia
Based on the molecular dynamics and structural studies corroborate that spike glycoprotein of SARS-CoV-2 is the drug target for the Arbidol. This incites the drug binding mode with its key interacting residues and its mechanism where Arbidol can effectively block or impede the trimerization of spike glycoprotein, which is essential for cell adherence and entry. Blocking the trimerization of spike glycoprotein also leads in the formation of naked or unmatured virus which are least infectious.
28 Feb 2020 Early antiviral therapy of abidol combined with lopinavir/ritonavir and recombinant interferon α-2b for patients with COVID-19 in Zhejiang: A multicenter prospective study.
Wei Runan, Zheng Nanhong, Jiang Xiangao, et al. Chin J Clin Infect Dis, 2020,13
The triple combination antiviral therapy of abidol, lopinavir/litonavir and rIFNα-2b shows shorter viral shedding time and shorter hospitalization time, compared with the dual combination antiviral therapy; and the earlier starting triple combination antiviral therapy will result in better antiviral efficacy.
16 Mar 2020 Clinical Features of 69 Cases With Coronavirus Disease 2019 in Wuhan, China
Wang Z et al Clin Infect Dis. Published online
Limited clinical experience with umifenovir for COVID-19 has been described in China. A nonrandomized study of 67 patients with COVID-19 showed that treatment with umifenovir for a median duration of 9 days was associated with lower mortality rates (0% [0/36] vs 16% [5/31]) and higher discharge rates compared with patients who did not receive the agent.
17 Mar 2020 Favipiravir versus Arbidol for COVID-19: A Randomized Clinical Trial
Chang Chen, Yi Zhang, Jianying Huang
Results 240 enrolled COVID-19 patients underwent randomization; 120 patients were assigned to receive Favipiravir (116 assessed), and 120 to receive Arbidol (120 assessed). Clinical recovery rate of Day 7 does not significantly differ between Favipiravir group (71/116) and Arbidol group (62/120) (P=0.1396, difference of recovery rate: 0.0954; 95% CI: -0.0305 to 0.2213).
31 Mar 2020 Arbidol combined with LPV/r versus LPV/r alone against Corona Virus Disease 2019: A retrospective cohort study. Deng L ei al Journal of Infection
In patients with COVID-19, the apparent favorable clinical response with arbidol and LPV/r supports further LPV/r only. The SARS-CoV-2 could not be detected for 12(75%) of 16 patients’ nasopharyngeal specimens in the combination group after seven days, compared with 6 (35%) of 17 in the monotherapy group (p < 0·05). After 14 days, 15 (94%) of 16 and 9 (52·9%) of 17, respectively, SARS-CoV-2 could not be detected (p < 0·05). The chest CT scans were improving for 11(69%) of 16 patients in the combination group after seven days, compared with 5(29%) of 17 in the monotherapy group (p < 0·05).
14 Apr 2020 Arbidol Monotherapy is Superior to Lopinavir/ritonavir in Treating COVID-19
Zhu, Zhen; Lu, Zhaohui; Xu, Tianmin et al. J Infect
Patients in the arbidol group had a shorter duration of positive RNA test compared to those in the lopinavir/ritonavir group (P<0.01). On day 14 after the admission, no viral load was detected in arbidol group, but the viral load was found in 15(44.1%) patients treated with lopinavir/ritonavir.
Important Safety Information
Active substances. Umifenovirum. АТC Code: J05AX13. INN: Umifenovirum. Pharmacotherapeutic group: antiviral agent. Pharmacodynamics. Arbidol is the antiviral medicinal product. It specifically inhibits in vitro viruses of influenza A and B and other viruses, i.e. agents of Acute Respiratory Virus Infections (ARVI). Based on its antiviral activity mechanism it belongs to the fusion inhibitors (fusions); it interacts with virus hemagglutinin. Contraindications. Hypersensitivity to Umifenovirum or any other component of the medicinal product; Paediatric patients under 2 years old. First trimester of pregnancy. Breast feeding period. Adverse reactions. Rare – allergic reactions.