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Favipiravir versus Arbidol for COVID-19: A Randomized Clinical Trial
Open accessPreprint — published as 10.3389/fphar.2021.683296
Abstract
Background: No clinically proven effective antiviral strategy exists for the epidemic Coronavirus Disease 2019 (COVID-19). Methods: We conducted a prospective, randomized, controlled, open-label multicenter trial involving adult patients with COVID-19. Patients were randomly assigned in a 1:1 ratio to receive conventional therapy plus Umifenovir (Arbidol) (200mg*3/day) or Favipiravir (1600mg*2/first day followed by 600mg*2/day) for 10 days. The primary outcome was clinical recovery rate of Day 7. Latency to relief for pyrexia and cough, the rate of auxiliary oxygen therapy (AOT) or noninvasive mechanical ventilation (NMV) were the secondary outcomes. Safety data were collected for 17 days. 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). Favipiravir led to shorter latencies to relief for both pyrexia (difference: 1.70 days, P<0.0001) and cough (difference: 1.75 days, P<0.0001). No difference was observed of AOT or NMV rate (both P>0.05). The most frequently observed Favipiravir-associated adverse event was raised serum uric acid (16/116, OR: 5.52, P=0.0014). Conclusions: Among patients with COVID-19, Favipiravir, compared to Arbidol, did not significantly improve the clinically recovery rate at Day 7. Favipiravir significantly improved the latency to relief for pyrexia and cough. Adverse effects caused Favipiravir are mild and manageable. This trial is registered with Chictr.org.cn (ChiCTR2000030254).
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“The subgroup effect is consistent with evidence from other meta-analyses.36”
From Drug treatments for covid-19: living systematic review and network meta-analysis (2020) · cites this paper as [36]
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“Arbidol is an inhibitor that blocks the fusion of the influenza virus with the cell and is active against coronavirus in vitro (5).”
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Self-citationShoaib, M. H., Ahmed, F. R., Sikandar, M., Yousuf, R. I., & Saleem, M. T. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.576448 · Cited by 18
Efficacy and Safety of New and Emerging Drugs for COVID-19: Favipiravir and Dexamethasone
Sood, S., Bhatia, G. K., Seth, P., et al. (2021) · Current Pharmacology Reports · doi:10.1007/s40495-021-00253-w · Cited by 19
Sumon, T. A., Hussain, M. A., Hasan, M. T., Hasan, M., Jang, W. J., Bhuiya, E. H., Chowdhury, A. A. M., Sharifuzzaman, S. M., Brown, C. L., Kwon, H., et al. (2021) · Frontiers in Molecular Biosciences · doi:10.3389/fmolb.2020.585899 · Cited by 22
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SARS-CoV-2 therapeutics: how far do we stand from a remedy?
Singh, A. K., & Gupta, V. (2021) · Pharmacological Reports · doi:10.1007/s43440-020-00204-0 · Cited by 23
Gusarov, S., & Stoyanov, S. R. (2020) · The Journal of Physical Chemistry Letters · doi:10.1021/acs.jpclett.0c02836 · Cited by 21
Parlakpınar, H., Polat, S., & Acet, H. (2020) · Fundamental & Clinical Pharmacology · doi:10.1111/fcp.12589 · Cited by 19
“It has been proposed for COVID19 based on its inhibitory effect on RNA-dependent RNA polymerase (RdRP) (43).”
BackgroundThe broad-spectrum antiviral recommendations for drug discovery against COVID-19
Hazafa, A., ur-Rahman, K., Haq, I. U., Jahan, N., Mumtaz, M., Farman, M. T., Naeem, H., Abbas, F., Naeem, M., Sadiqa, S., et al. (2020) · Drug Metabolism Reviews · doi:10.1080/03602532.2020.1770782 · Cited by 23
“…by 600mg twice daily up to 10 days) and Arbidol (200mg thrice daily up-to 10 days) to COVID-19-infected patients (120:120) showed that Favipiravir has better results (p< 0.0001) than Arbidol (p¼ 0.1396) with a significant reduction in cough and pyrexia COVID-19 infected patients (Chen et al. 2020).”
BackgroundInfluentialTreatments for COVID-19: emerging drugs against the coronavirus - reply.
Potì, F., Pozzoli, C., Adami, M., Poli, E., & Costa, L. G. (2020) · Acta bio-medica dell'Ateneo parmense/Acta biomedica · doi:10.23750/abm.v91i2.9639 · Cited by 22
“moderate to severe COVID-19 infection (85).”
Response to "Dose Rationale for Favipiravir Use in Patients Infected With SARS‐CoV‐2"
Du, Y.-X., & Chen, X.-P. (2020) · Clinical pharmacology and therapy · doi:10.1002/cpt.1878 · Cited by 19
Балыкова, Л. А., Granovskaya, M. V., Zaslavskaya, K. Y., Simakina, E. N., Agafina, A. S., Ivanova, A. Y., Kolontarev, K. B., & DIu, P. (2020) · Infectious diseases News Opinions Training · doi:10.33029/2305-3496-2020-9-3-16-29 · Cited by 20
Diagnosis, prevention, and treatment of coronavirus disease: a review
Sarangi, M. K., Padhi, S. K., Dheeman, S., Karn, S. K., Patel, L. D., Yi, D. K., & Nanda, S. S. (2021) · Expert Review of Anti-infective Therapy · doi:10.1080/14787210.2021.1944103 · Cited by 19
“[67] hypothesized that favipiravir is superior to umifenovir because of its efficacy in treating moderate symp-”
BackgroundDrug repurposing: new strategies for addressing COVID-19 outbreak
Shende, P. K., Khanolkar, B., & Gaud, R. (2020) · Expert Review of Anti-infective Therapy · doi:10.1080/14787210.2021.1851195 · Cited by 24
“019), however, no significant differences were noticed in the severe or severe and moderate (combined) arms [17].”
BackgroundCurrent and Future Direct-Acting Antivirals Against COVID-19
Chan, S. (2020) · Frontiers in Microbiology · doi:10.3389/fmicb.2020.587944 · Cited by 21
“Other modifications of enfuvirtide: PEGylation, glycosylation and ligation with a human IgG Fc-binding peptide all increased potency and half-life (Cheng et al., 2015; Bi et al., 2019; Wang et al., 2019).”
BackgroundA contemporary look at COVID-19 medications: available and potentially effective drugs.
Alshaeri, H., & Natto, Z. (2020) · European Review for Medical and Pharmacological Sciences · doi:10.26355/eurrev_202009_22870 · Cited by 18
Kumar, S., Basu, M., Ghosh, P., Pal, U., & Ghosh, M. K. (2023) · Genes & Diseases · doi:10.1016/j.gendis.2022.12.019 · Cited by 25
“, elevation in uric acid level, abnormal GIT symptoms, abnormality in liver enzymes, and psychotropic side effects.(55) Further, favipiravir in combination with IFNa aerosol inhalation in COVID-19 was evaluated in another open-label clinical study, which showed better chest computed tomography (CT) image and rapid vir…”
Piya, A. A., Ahmed, T., Khaleque, M., et al. (2022) · Computational and Theoretical Chemistry · doi:10.1016/j.comptc.2022.113902 · Cited by 17
“[4] found that Favipiravir might be an effective medicine against COVID-19 by improving the recovery rate on Day 7.”
BackgroundDrug repurposing strategies and key challenges for COVID-19 management
Mule, S., Singh, A., Greish, K. F., Sahebkar, A., Kesharwani, P., & Shukla, R. (2021) · Journal of drug targeting · doi:10.1080/1061186x.2021.2013852 · Cited by 22
“019 showed variations in clinical improvements on day 7, but there were no major variations in the severe or moderate and severe (combination) groups [106].”
BackgroundDrug-Based Therapeutic Strategies for COVID-19-Infected Patients and Their Challenges
Zarkesh, K., Entezar-Almahdi, E., Ghasemiyeh, P., Akbarian, M., Bahmani, M., Roudaki, S., Fazlinejad, R., Mohammadi‐Samani, S., Firouzabadi, N., Hosseini, M., et al. (2021) · Future Microbiology · doi:10.2217/fmb-2021-0116 · Cited by 18
Hossain, M. J., Jannat, T., Brishty, S. R., Roy, U., Mitra, S., Rafi, M. O., Islam, M. R., Nesa, M. L., Islam, M. R., & Emran, T. B. (2021) · Biologics · doi:10.3390/biologics1020016 · Cited by 16
Bosaeed, M., Mahmoud, E., Alharbi, A. M., Altayib, H., Albayat, H., Alharbi, F. G., Ghalilah, K. M., Arfaj, A. A., Al-Jishi, J. M., Alarfaj, A., et al. (2021) · Infectious Diseases and Therapy · doi:10.1007/s40121-021-00496-6 · Cited by 23
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“Few clinical trials have also validated the antiviral action of these drugs in COVID-19 patients (Chen et al., 2020b; Gao et al., 2020; Gautret et al., 2020).”
Rohilla, S. (2020) · Drug development research (Print) · doi:10.1002/ddr.21720 · Cited by 17
“…may also develop acute respiratory distress syndrome (ARDS), respiratory failure, acute cardiac injury, coagulation abnormalities, disturbed immune system causing amplified cytokines release, and multiple organ failure resulting in death (Chen et al., 2020; Huang et al., 2020; Wang et al., 2020).”
BackgroundRepurposing clinically available drugs and therapies for pathogenic targets to combat SARS‐CoV‐2
Xue, Y., Mei, H., Chen, Y., Griffin, J. D., Liu, Q., Weisberg, E., & Yang, J. C. (2023) · MedComm · doi:10.1002/mco2.254 · Cited by 20
A Comprehensive Review on the Efficacy of Several Pharmacologic Agents for the Treatment of COVID-19
Haddad, F., Dokmak, G., & Karaman, R. (2022) · Life · doi:10.3390/life12111758 · Cited by 25
“Favipiravir was given to half of the patients, and Arbidol (umifenovir) was given to the remaining patients (Figure 1e) [57].”
BackgroundInfluentialAmparo, T. R., Seibert, J. B., Silveira, B. M., Costa, F. S. F., Almeida, T. C., Braga, S. F. P., da Silva, G. N., dos Santos, O. D. H., & de Souza, G. H. B. (2021) · Phytochemistry Reviews · doi:10.1007/s11101-021-09754-4 · Cited by 25
“nelfinavir, prulifloxacin, hydroxychloroquine, arbidol, remdesivir and favipiravir (Arya et al. 2020; Lin et al. 2018; Qamar et al. 2020; Fantini et al. 2020; Zhu et al. 2020; Wang et al. 2020; Chen et al. 2020).”
BackgroundInfluentialHonarmand, K., Penn, J. B., Agarwal, A., Siemieniuk, R. A. C., Brignardello‐Petersen, R., Bartoszko, J. J., Zeraatkar, D., Agoritsas, T., Burns, K. E. A., Fernando, S. M., et al. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.07.002 · Cited by 16
Pipeline Pharmacological Therapies in Clinical Trial for COVID-19 Pandemic: a Recent Update
Kumari, P., Rawat, K., & Saha, L. (2020) · Current Pharmacology Reports · doi:10.1007/s40495-020-00226-5 · Cited by 19
Hasan, M., Parvez, M. S. A., Azim, K. F., et al. (2020) · doi:10.26434/chemrxiv.12118857 · Cited by 16
“[51] Chen C, Huang J, Cheng Z, Wu J, Chen S, Zhang Y, et al.”
BackgroundStructure-Based Drug Design of RdRp Inhibitors against SARS-CoV-2
Shehzadi, K., Saba, A., Yu, M., & Liang, J. (2023) · Topics in Current Chemistry · doi:10.1007/s41061-023-00432-x · Cited by 19
“FPV’s most important side effect was teratogenicity, followed by abnormal liver enzymes, mental symptoms, intestinal symptoms and elevation in serum uric acid in a randomized test of FPV in 241 patients with SARS-CoV-2 [77].”
BackgroundLaw, M. F., Ho, R., Law, K. W. T., & Cheung, C. K. M. (2021) · World Journal of Hepatology · doi:10.4254/wjh.v13.i12.1850 · Cited by 21
Evaluation of favipiravir in the treatment of COVID-19 based on the real-world
Deng, W., Yang, C.-R., Yang, S., et al. (2021) · Expert Review of Anti-Infective Therapy · doi:10.1080/14787210.2022.2012155 · Cited by 15
Duse, P., & Baheti, K. (2021) · Journal of Pharmaceutical Research International · doi:10.9734/jpri/2021/v33i47a33014 · Cited by 15
Thiruchelvam, K., Kow, C. S., Hadi, M., et al. (2021) · Expert Review of Anti-Infective Therapy · doi:10.1080/14787210.2021.1949984 · Cited by 15
Nasir, M., Perveen, R., Murshed, M., et al. (2021) · doi:10.9734/jpri/2020/v32i4531088 · Cited by 15
“At first china and Japan, then many countries around the world started to use favipiravir against SARS-CoV-2, though the scarcity of published RCTs reflects a lack of significant evidence in favor of it [10].”
BackgroundRisk management strategies and therapeutic modalities to tackle COVID-19/SARS-CoV-2
Shah, S. M. A., Rasheed, T., Rızwan, K., Bilal, M., Iqbal, H. M. N., Rasool, N., Toma, S. I., Marceanu, L. G., & Bobescu, E. (2020) · Journal of Infection and Public Health · doi:10.1016/j.jiph.2020.12.023 · Cited by 22
“One comparative study of arbidol gainst favipiravir showed that favipiravir is superior to arbidol in ombating SARS-CoV-2 [82].”
Metadata
- Authors
- Chen, C., Zhang, Y., Huang, J., Yin, P., Cheng, Z., Wu, J., Chen, S., Zhang, Y., Chen, B., Lu, M., Luo, Y., Ju, L., Zhang, J., & Wang, X.
- Affiliations
- Zhongnan Hospital of Wuhan University (CN)
- Peking University (CN)
- Huazhong University of Science and Technology (CN)
- Hubei Zhongshan Hospital (CN)
- Corresponding author
- Wang, Xinghuan
- ORCID
- Venue
- Frontiers in Pharmacology
- Publisher
- openRxiv
- Published
- 2020-03-20
- Volume
- 12
- Pages
- 683296-683296
- ISSN
- 1663-9812 (ISSN-L)
- PMC
- PMC8443786
- OpenAlex
- W3197627421
- Cited by
- 852
- References
- 12
- Citations by year
- 2026: 2 · 2025: 18 · 2024: 32 · 2023: 54 · 2022: 136 · 2021: 231 · 2020: 379
- FWCI
- 36.00
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Frontiers in Pharmacology (publishedVersion, cc-by)
- medRxiv (acceptedVersion)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Capital Medical University
- Huazhong University of Science and Technology
- Tongji University
- Wuhan University
- Wuhan University of Science and Technology
- Shanghai University of Traditional Chinese Medicine
- Longhua Hospital Shanghai University of Traditional Chinese Medicine
- Science and Technology Department of Hubei Province
- National Key Research and Development Program of China (2020YFC0844400)
- Topics
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Clinical Neurology › Long-Term Effects of COVID-19
- Keywords
- favipiravir, umifenovir, arbidol, COVID-19 pandemic, antiviral therapy, clinical recovery, non-invasive ventilation, mechanical ventilation, serum uric acid, drug safety, SARS-CoV-2, adults, randomized trial comparison, adverse events
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