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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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Investigational Drugs for the COVID 19 Pandemic – A Concise Review
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Arora, A., Kumari, A., Arora, A., et al. (2020) · doi:10.47583/ijpsrr.2020.v64i01.037 · Cited by 1
Alhassane, D., Marie, T., Miguel, C., et al. (2020) · doi:10.23937/2474-3658/1510151 · Cited by 1
“For the safety outcome, the network meta-analysis was performed in all 14 RCTs, yielding 11 treatments and 16 comparisons.”
BackgroundMethodInfluentialHISTÓRIA NATURAL DA COVID-19 E SUAS RELAÇÕES TERAPÊUTICAS
de Meneses, A. S. (2020) · doi:10.1590/scielopreprints.733 · Cited by 1
“SciELO Preprints, 2020 3 Figura 2 - História Natural da COVID-19 e suas Relações Terapêuticas, 2020((8-48)).”
BackgroundCOVID-19 Therapeutics Outcome: Systematic Review and Data AnalysisPreprint
Tobaiqy, M. A., Helmi, N. M., Majrashi, M., Aldahery, S. T., & Mujallad, A. (2020) · doi:10.21203/rs.3.rs-33391/v1 · Cited by 1
“Interferon alfa-1b 3(60%) Favipiravir 2(40%) Umifenovir 1(20%) Darunavir 1(20%) China Caseseries 5 Critically ill patients withsevere ARDS Range (36-65) 5 (100%) 5 (100%) 3 (60%) Patients were on antiviralagents and improved after starting convalescent plasma transfusion 0 Chenguang Shen et al2020”
BackgroundInfluentialMisra, S., Nath, M., Hadda, V., et al. (2020) · medRxiv · doi:10.1101/2020.05.24.20111799 · Cited by 1
“20 Chen C, 2020 (63) China Multicentre Open label RCT 236 .”
BackgroundSystematic and Statistical Review of COVID19 Treatment Trials (Preprint)
Siordia, J., Bernaba, M., Yoshino, K., et al. (2020) · doi:10.2196/preprints.20503 · Cited by 1
Treatments administered to the first 9,152 reported cases of COVID19: a systematic review
Fajgenbaum, D., Khor, J., Gorzewski, A., et al. (2020) · medRxiv · doi:10.1101/2020.05.07.20073981 · Cited by 1
“[22] Convalescent plasma was only given in 12 cases, but it was used previously to treat MERS and SARS and a number of studies are underway.”
MethodA Brief Overview of Current Drug Repurposing Approaches for COVID-19 Management
Rodrigues, P. F. S., & Thomaz, D. V. (2020) · doi:10.22178/pos.57-1 · Cited by 1
Ye, Z., Rochwerg, B. N., Wang, Y., Adhikari, N. K. J., Murthy, S., Lamontagne, F., Fowler, R., Qiu, H., Wei, L., Sang, L., et al. (2020) · Canadian Medical Association Journal · doi:10.1503/cmaj.200648-f · Cited by 1
Akhmerov, A., & Marbán, E. (2020) · Circulation Research · doi:10.1161/circresaha.120.317055 · Cited by 700
Pinki, P., Subhash, S., & Chaudhary, A. (2021) · Asian Journal of Chemistry · doi:10.14233/ajchem.2021.23228 · Cited by 1
Insights into COVID-19 Chemotherapies: Potential and Challenges
Yahya, E. B. (2021) · Journal of Chemistry and Nutritional Biochemistry · doi:10.48185/jcnb.v2i1.168 · Cited by 1
Ongoing Clinical Trials and the Potential Therapeutics for COVID-19 Treatment
Abolhassani, H., Bashiri, G., Montazeri, M., Kouchakzadeh, H., Shojaosadati, S. A., & Siadat, S. E. R. (2021) · Springer eBooks · doi:10.1007/978-981-16-3108-5_2
Evidence of the Clinical Efficacy of Antiviral Agents against SARS-CoV-2
Welman, A., & Outhoff, K. (2021) · International Journal Of Pharmaceutical Research And Allied Sciences · doi:10.51847/e3axgwu0ip · Cited by 2
Safety profile assessment of drug products used for the pathogenetic treatment of COVID19
Syraeva, G., Mishinova, S. A., Kolbin, A., et al. (2021) · Clinical Microbiology and Antimicrobial Chemotherapy · doi:10.36488/cmac.2021.3.314-329 · Cited by 1
Approaches for the Treatment of SARS-CoV-2 Infection: A Pharmacologic View and Literature Review.
Barzelighi, H. M., Daraei, B., & Dastan, F. (2020) · PubMed Central · doi:10.22037/ijpr.2020.113821.14506 · Cited by 1
Talaei, S., Mellatyar, H., Mohammadi, S., Panahi, Y., Kianpour, P., Akbarzadeh, A., & Zarghami, N. (2020) · EURAS Journal of Health · doi:10.17932/ejoh.2020.022/ejoh_v02i1001
“Angiotensin-converting enzyme 2 (ACE2) has been reported as an entry receptor for SARS-CoV-2 infection and it has been proposed which blocking this interaction might be used in treatment of persons with COVID-19 infection (24).”
BackgroundAn overview of the safety assessment of medicines currently used in the COVID-19 disease treatment
Javorac, D., Grahovac, L., Manić, L., Stojilković, N., Anđelković, M., Bulat, Z., Ćosić, D. Đ., Ćurčić, M., & Djordjević, A. B. (2020) · Food and Chemical Toxicology · doi:10.1016/j.fct.2020.111639 · Cited by 51
“Due to mechanism of action, the medicine has been recognized as potential therapy for novel SARS-CoV-2 infection (Chen et al., 2020).”
Pérez-García, A., Villalobos-Osnaya, A., Hernández-Medel, M., et al. (2020) · doi:10.21203/rs.3.rs-107427/v1
“1600 mg bid on day 1 and 600 mg bid days 2-7] FIGURE 1 Eligibility criteria Screening: Upon admission, screening criteria will be applied in the Emergency service to select the candidates Adult patients (18-80) Within 12 days of the appearance of symptoms Severe non-critical clinical stage at admission At least one of…”
InfluentialComprehensive and translational pathobiology of COVID-19 based on cellular and molecular techniques
Samadani, A. A., Vahidi, S., Babaei, K., Norollahi, S. E., Delpasand, K., & Gharakhyli, E. A. (2025) · Practical Laboratory Medicine · doi:10.1016/j.plabm.2025.e00497
“Evaluation of Favipiravir vs umifenovir in COVID-19 determined that favipiravir with inhibition of viral RNA polymerase is more effective than umifenovir [128].”
Challenges of consolidating evidence collected during a pandemic and lessons for the future
Abògúnr̀in, Ṣ., Adelakun, A., Akinola, T., Bashir, U., Fagbohungbe, B. F., Mueller, E., Neeser, K., Ogunnubi, O. P., & Parekh, K. (2024) · Current Medical Research and Opinion · doi:10.1080/03007995.2024.2377676
Use of Favipiravir in Covid-19 Patients: A Narrative Review
Ningrum, V. D. A., Fitria, A., & Hanur, F. U. (2024) · JPSCR Journal of Pharmaceutical Science and Clinical Research · doi:10.20961/jpscr.v9i1.73629
“(Chen et al., 2021; Doi et al., 2020).”
BackgroundInfluentialInayah, A. F., Putri, G. S., & Anggraeni, A. D. (2024) · Eduvest - Journal Of Universal Studies · doi:10.59188/eduvest.v4i5.1277
“According to a study by Chen et al., (2020) Favipiravir showed better ability in clinical recovery rates reducing symptoms of fever and cough with doses given (2x1600mg) po on the first day then (2x600mg) on days 2-7.”
MethodYulia, R., Herawati, F., Hima, K. R., et al. (2023) · Jurnal Ilmiah Ibnu Sina · doi:10.36387/jiis.v8i2.1486
Nunes, D. R., Lucchi, D. B. M., Andreata‐Santos, R., Janini, L. M., & Braconi, C. T. (2023) · Frontiers in Drug Discovery · doi:10.3389/fddsv.2023.1176768 · Cited by 2
“One of the most evident lessons from the COVID-19 pandemic is the extensive and rapid antiviral drug repurposing by using highthroughput screening methods with numerous research groups (Chen, 2020; Rodon et al., 2021; Hamed et al., 2022).”
BackgroundSpectrum of COVID-19-induced liver injury in children
Celik, M. (2023) · Gastrointestinal Tract · doi:10.54844/git.2023.333
Emerging Treatment Regimens In Pharmaceutics During Post Covid-19 Epidemic
Chandra, K. (2023) · NeuroQuantology · doi:10.48047/nq.2022.20.4.nq22354
Assareh, E., Abbasi, M. A., Heidari, M., & Asghari, S. M. (2023) · Iranian Journal of Science · doi:10.1007/s40995-022-01400-8
“Recent in vitro and clinical studies have exhibited the capability of favipiravir to inhibit SARS-CoV-2 replication (Choy et al. 2020), improve the symptoms of COVID-19 patients, and reduce the treatment period (Chen et al. 2020a, b).”
BackgroundDelen, L. A. (2022) · Acta Clinica Croatica · doi:10.20471/acc.2022.61.03.05
In Silico Testing of Some Protected Galactopyranose as SARS-CoV-2 Main Protease Inhibitors
Azad, A., Islam, M. N., Chowdhury, M. A. I., et al. (2022) · Journal of Applied Science & Process Engineering · doi:10.33736/jaspe.4970.2022
Application of stochastic models in COVID-19
Wang, Y. (2022) · Other Conferences · doi:10.1117/12.2648111
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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