Safety and efficacy of favipiravir for the management of COVID-19 patients: A preliminary randomized control trial
S M Abdur Rahman, Ahmedul Kabir, Md Abm B M Abdullah, Md Billal Alam, Khan Abul Kalam Azad, Md Titu Miah, Syed Ghulam Mogni Mowla, Sudip Ranjan Deb, Mohammad Robed Amin, Muhammad Asaduzzaman
Clinical Infection in Practice, doi:10.1016/j.clinpr.2022.100145
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Table-5: Assessment of Adverse effects of patients of both groups 4%) 0 (0%) 0 (0%) 1 (4%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) Jaundice 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) Skin rash 1 (4%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) Liver damage 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 2(8%) 0 (0%) 1 (4%) Anemia 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) Vertigo 2 (8%) 2 (8%) 2 (8%) 2 (8%) 0 (0%) 2 (8%) 0 (0%) 1 (4%) Anosmia 1 (4%) 0 (0%) 1 (4%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Conflict of Interest: The authors declared that there was no conflict of interest regarding the clinical trial. Funding: Beacon Pharmaceuticals Limited, Dhaka, Bangladesh.
References Author Contributions:
References
Alam, Kamal, Sarkar, Zhou, Rahman et al., Therapeutic effectiveness and safety of repurposing drugs for the treatment of COVID-19: position standing in 2021, Front Pharmacol,
doi:10.3389/fphar.2021.659577
Cucinotta, Vanelli, WHO declares COVID-19 a pandemic, Acta Biomed
Delang, Favipiravir as a potential countermeasure against neglected and emerging RNA viruses, Antiviral Res
Du, Chen, Favipiravir: Pharmacokinetics and concerns about clinical trials for 2019-nCoV infection, Clinical Pharmacology and Therapeutics
Filho, Covid-19 and the UN Sustainable Development Goals: Threat to Solidarity or an Opportunity?, Sustainability,
doi:10.3390/su12135343
Furuta, Favipiravir (T-705), a broad spectrum inhibitor of viral RNA polymerase, Proc. Jpn. Acad. Ser. B Phys. Biol. Sci
Furuta, Favipiravir (T-705), a novel viral RNA polymerase inhibitor, Antiviral Res
Hassanipour, Arab-Zozani, Amani, Heidarzad, Fathalipour et al., The efficacy and safety of Favipiravir in treatment of COVID-19: a systematic review and meta-analysis of clinical trials, Scientific reports
Hossain, Hridoy, Rahman, Ahmad, Major depressive and Generalized anxiety disorders among university students during the second wave of COVID-19 outbreak in Bnagladesh. Asia Pac, J. Pubic Health
Hossain, Rahman, Repurposing therapeutic agents againsts SARS-CoV-2 infection: most promising and neoteric progress, Expert Rev Antiinfective Therapy,
doi:10.1080/14787210.2021.1864327
Huang, Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, Lancet
Li, Clercq, Therapeutic options for the 2019 novel coronavirus (2019-nCoV), Nat Rev Drug Discov
Lu, Outbreak of pneumonia of unknown etiology in Wuhan China: the mystery and the miracle, J Med Virol,
doi:10.1002/jmv.25678
Nicola, The Socio-economic implications of the coronavirus pandemic (COVID-19): A review, Int. J. Surg
Nigata, Favipiravir: a new medication for the ebola virus disease pandemic, Disaster Medicine and Public Health preparedness
Pilkington, A review of the safety of favipiravir-a potential treatment in the COVID-19 pandemic?, J. Virus Erad
Roser, Coronavirus Disease (COVID-19)-Statistics and Research
Sleeman, In vitro antiviral activity of favipiravir (T-705 ) against drug-resistant influenza and 2009 a (H1N1) viruses, Antimicrob Agents Chemother
Wang, Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China, JAMA
Wang, Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019nCoV) in vitro, Cell Res
Weiss, Murdoch, Clinical course and mortality risk of severe COVID-19, Lancet
Zhou, Clinical course and risk factors mortality of adult inpatients with COVID-19 in Wuhan, China:a retrospective cohort study, Lancet
{ 'indexed': {'date-parts': [[2022, 5, 12]], 'date-time': '2022-05-12T03:40:55Z', 'timestamp': 1652326855425},
'reference-count': 30,
'publisher': 'Elsevier BV',
'license': [ { 'start': { 'date-parts': [[2022, 5, 1]],
'date-time': '2022-05-01T00:00:00Z',
'timestamp': 1651363200000},
'content-version': 'tdm',
'delay-in-days': 0,
'URL': 'https://www.elsevier.com/tdm/userlicense/1.0/'},
{ 'start': { 'date-parts': [[2022, 4, 22]],
'date-time': '2022-04-22T00:00:00Z',
'timestamp': 1650585600000},
'content-version': 'vor',
'delay-in-days': 0,
'URL': 'http://creativecommons.org/licenses/by-nc-nd/4.0/'}],
'content-domain': {'domain': [], 'crossmark-restriction': False},
'published-print': {'date-parts': [[2022, 5]]},
'DOI': '10.1016/j.clinpr.2022.100145',
'type': 'journal-article',
'created': {'date-parts': [[2022, 5, 12]], 'date-time': '2022-05-12T03:11:37Z', 'timestamp': 1652325097000},
'page': '100145',
'source': 'Crossref',
'is-referenced-by-count': 0,
'title': 'Safety and Efficacy of Favipiravir for the management of COVID-19 Patients: A Randomized Control '
'Trial',
'prefix': '10.1016',
'author': [ {'given': 'S.M. Abdur', 'family': 'Rahman', 'sequence': 'first', 'affiliation': []},
{'given': 'Ahmedul', 'family': 'Kabir', 'sequence': 'additional', 'affiliation': []},
{'given': 'ABM', 'family': 'Abdullah', 'sequence': 'additional', 'affiliation': []},
{'given': 'Md', 'family': 'Billal Alam', 'sequence': 'additional', 'affiliation': []},
{'given': 'Khan Abul Kalam', 'family': 'Azad', 'sequence': 'additional', 'affiliation': []},
{'given': 'Md', 'family': 'Titu Miah', 'sequence': 'additional', 'affiliation': []},
{'given': 'Syed Ghulam Mogni', 'family': 'Mowla', 'sequence': 'additional', 'affiliation': []},
{'given': 'Sudip Ranjan', 'family': 'Deb', 'sequence': 'additional', 'affiliation': []},
{'given': 'Mohammad Robed', 'family': 'Amin', 'sequence': 'additional', 'affiliation': []},
{'given': 'Muhammad', 'family': 'Asaduzzaman', 'sequence': 'additional', 'affiliation': []}],
'member': '78',
'reference': [ { 'issue': '4',
'key': '10.1016/j.clinpr.2022.100145_b0005',
'doi-asserted-by': 'crossref',
'first-page': '401',
'DOI': '10.1002/jmv.25678',
'article-title': 'Outbreak of pneumonia of unknown etiology in Wuhan China: the mystery '
'and the miracle',
'volume': '92',
'author': 'Lu',
'year': '2020',
'journal-title': 'J Med Virol.'},
{ 'issue': '11',
'key': '10.1016/j.clinpr.2022.100145_b0010',
'doi-asserted-by': 'crossref',
'first-page': '1061',
'DOI': '10.1001/jama.2020.1585',
'article-title': 'Clinical characteristics of 138 hospitalized patients with 2019 novel '
'coronavirus-infected pneumonia in Wuhan',
'volume': '323',
'author': 'Wang',
'year': '2020',
'journal-title': 'JAMA'},
{ 'issue': '10223',
'key': '10.1016/j.clinpr.2022.100145_b0015',
'doi-asserted-by': 'crossref',
'first-page': '497',
'DOI': '10.1016/S0140-6736(20)30183-5',
'article-title': 'Clinical features of patients infected with 2019 novel coronavirus in '
'Wuhan',
'volume': '395',
'author': 'Huang',
'year': '2020',
'journal-title': 'China. Lancet'},
{ 'issue': '10229',
'key': '10.1016/j.clinpr.2022.100145_b0020',
'doi-asserted-by': 'crossref',
'first-page': '1054',
'DOI': '10.1016/S0140-6736(20)30566-3',
'article-title': 'Clinical course and risk factors for mortality of adult inpatients with '
'COVID-19 in Wuhan, China:a retrospective cohort study',
'volume': '395',
'author': 'Zhou',
'year': '2020',
'journal-title': 'Lancet'},
{ 'issue': '10229',
'key': '10.1016/j.clinpr.2022.100145_b0025',
'doi-asserted-by': 'crossref',
'first-page': '1014',
'DOI': '10.1016/S0140-6736(20)30633-4',
'article-title': 'Clinical course and mortality risk of severe COVID-19',
'volume': '395',
'author': 'Weiss',
'year': '2020',
'journal-title': 'Lancet'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0030',
'unstructured': 'Worldometer: https://www.worldometers.info/coronavirus/. Accessed 5th '
'April, 2021.'},
{ 'issue': '1',
'key': '10.1016/j.clinpr.2022.100145_b0035',
'first-page': '157',
'article-title': 'WHO declares COVID-19 a pandemic',
'volume': '91',
'author': 'Cucinotta',
'year': '2020',
'journal-title': 'Acta Biomed'},
{ 'issue': '5',
'key': '10.1016/j.clinpr.2022.100145_b0040',
'doi-asserted-by': 'crossref',
'first-page': '676',
'DOI': '10.1177/10105395211014345',
'article-title': 'Major depressive and Generalized anxiety disorders among university '
'students during the second wave of COVID-19 outbreak in Bnagladesh',
'volume': '33',
'author': 'Hossain',
'year': '2021',
'journal-title': 'Asia Pac. J. Pubic Health'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0045',
'doi-asserted-by': 'crossref',
'first-page': '185',
'DOI': '10.1016/j.ijsu.2020.04.018',
'article-title': 'The Socio-economic implications of the coronavirus pandemic (COVID-19): '
'A review',
'volume': '78',
'author': 'Nicola',
'year': '2020',
'journal-title': 'Int. J. Surg.'},
{ 'issue': '13',
'key': '10.1016/j.clinpr.2022.100145_b0050',
'doi-asserted-by': 'crossref',
'first-page': '5343',
'DOI': '10.3390/su12135343',
'article-title': 'Covid-19 and the UN Sustainable Development Goals: Threat to Solidarity '
'or an Opportunity?',
'volume': '12',
'author': 'Leal Filho',
'year': '2020',
'journal-title': 'Sustainability'},
{ 'issue': '8',
'key': '10.1016/j.clinpr.2022.100145_b0055',
'doi-asserted-by': 'crossref',
'first-page': '1009',
'DOI': '10.1080/14787210.2021.1864327',
'article-title': 'Repurposing therapeutic agents againsts SARS-CoV-2 infection: most '
'promising and neoteric progress',
'volume': '19',
'author': 'Hossain',
'year': '2021',
'journal-title': 'Expert Rev Antiinfective Therapy.'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0060',
'doi-asserted-by': 'crossref',
'DOI': '10.3389/fphar.2021.659577',
'article-title': 'Therapeutic effectiveness and safety of repurposing drugs for the '
'treatment of COVID-19: position standing in 2021',
'volume': '12',
'author': 'Alam',
'year': '2021',
'journal-title': 'Front Pharmacol.'},
{ 'issue': '3',
'key': '10.1016/j.clinpr.2022.100145_b0065',
'doi-asserted-by': 'crossref',
'first-page': '149',
'DOI': '10.1038/d41573-020-00016-0',
'article-title': 'Therapeutic options for the 2019 novel coronavirus (2019-nCoV)',
'volume': '19',
'author': 'Li',
'year': '2020',
'journal-title': 'Nat Rev Drug Discov.'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0070',
'unstructured': 'NIH US. National Library of Medicine ClinicalTrial.gov. '
'https://clinicaltrials.gov/ct2/home.Accessed September 5, 2020.'},
{ 'issue': '2',
'key': '10.1016/j.clinpr.2022.100145_b0075',
'doi-asserted-by': 'crossref',
'first-page': '446',
'DOI': '10.1016/j.antiviral.2013.09.015',
'article-title': 'Favipiravir (T-705), a novel viral RNA polymerase inhibitor',
'volume': '100',
'author': 'Furuta',
'year': '2013',
'journal-title': 'Antiviral Res.'},
{ 'issue': '1',
'key': '10.1016/j.clinpr.2022.100145_b0080',
'doi-asserted-by': 'crossref',
'first-page': '79',
'DOI': '10.1017/dmp.2014.151',
'article-title': 'Favipiravir: a new medication for the ebola virus disease pandemic',
'volume': '9',
'author': 'Nagata',
'year': '2015',
'journal-title': 'Disaster Medicine and Public Health preparedness'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0085',
'doi-asserted-by': 'crossref',
'first-page': '85',
'DOI': '10.1016/j.antiviral.2018.03.003',
'article-title': 'Favipiravir as a potential countermeasure against neglected and '
'emerging RNA viruses',
'volume': '153',
'author': 'Delang',
'year': '2018',
'journal-title': 'Antiviral Res.'},
{ 'issue': '6',
'key': '10.1016/j.clinpr.2022.100145_b0090',
'doi-asserted-by': 'crossref',
'first-page': '2517',
'DOI': '10.1128/AAC.01739-09',
'article-title': 'In vitro antiviral activity of favipiravir (T-705) against '
'drug-resistant influenza and 2009 a (H1N1) viruses',
'volume': '54',
'author': 'Sleeman',
'year': '2010',
'journal-title': 'Antimicrob Agents Chemother.'},
{ 'issue': '3',
'key': '10.1016/j.clinpr.2022.100145_b0095',
'doi-asserted-by': 'crossref',
'first-page': '269',
'DOI': '10.1038/s41422-020-0282-0',
'article-title': 'Remdesivir and chloroquine effectively inhibit the recently emerged '
'novel coronavirus (2019nCoV) in vitro',
'volume': '30',
'author': 'Wang',
'year': '2020',
'journal-title': 'Cell Res'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0100',
'article-title': 'Experimental treatment with favipiravir for COVID-19: An open-label '
'control study',
'author': 'Cai',
'year': '2020',
'journal-title': 'Engineering (Beijing)'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0105',
'unstructured': 'Roser M, et.al. Coronavirus Disease (COVID-19)-Statistics and Research. '
'Published online at OurworldData.org. retrieved from '
'https://ourworldindata.org/coronavirus. Accessed 8 Sep 2020.'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0110',
'doi-asserted-by': 'crossref',
'DOI': '10.3389/fimmu.2020.01991',
'article-title': 'The impact of Pre-existing comorbidities and Therapeutic Interventions '
'on COVID-19',
'volume': '11',
'author': 'Callender',
'year': '2020',
'journal-title': 'Front. Immunol.'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0115',
'unstructured': 'Pharmaceuticals and Medical Devices Agency, Report on the deliberation '
'results – avigan. Japan; Evaluation and Licensing Division, '
'Pharmaceutical and Food Safety Bureau, 2011. Available at: '
'www.pmda.go.jp/files/000210319.pdf. Accessed September 20, 2020.'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0120',
'unstructured': 'COVID-19: Glenmark’s favipiravir shows encouraging results in phase 3 '
'clinical trial. The Indian Express. '
'https://www.newindianexpress.com/nation/2020/jul/23/covid-19-glenmarks-favipiravir-shows-encouraging-results-in-phase-3-clinical-trial-2173500.html. '
'Accessed Septembe 23r, 2020.'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0125',
'article-title': 'Favipiravir versus arbidol for COVID-19: A randomized clinical trial',
'author': 'Chen',
'year': '2020',
'journal-title': 'medRxiv.'},
{ 'key': '10.1016/j.clinpr.2022.100145_b0130',
'unstructured': 'Trial site news. Russia ministry of health approves avifavir '
'(favipiravir) for COVID-19 patients—cuts duration of illness by over 50 '
'%. '
'https://www.trialsitenews.com/russia-ministry-of-health-approves-avifavir-favipiravir-for-covid-19-patients-cuts-duration-of-illness-by-over-50/. '
'Accessed September 1, 2020).'},
{ 'issue': '1',
'key': '10.1016/j.clinpr.2022.100145_b0135',
'doi-asserted-by': 'crossref',
'DOI': '10.1038/s41598-021-90551-6',
'article-title': 'The efficacy and safety of Favipiravir in treatment of COVID-19: a '
'systematic review and meta-analysis of clinical trials',
'volume': '11',
'author': 'Hassanipour',
'year': '2021',
'journal-title': 'Scientific reports.'},
{ 'issue': '7',
'key': '10.1016/j.clinpr.2022.100145_b0140',
'doi-asserted-by': 'crossref',
'first-page': '449',
'DOI': '10.2183/pjab.93.027',
'article-title': 'Favipiravir (T-705), a broad spectrum inhibitor of viral RNA polymerase',
'volume': '93',
'author': 'Furuta',
'year': '2017',
'journal-title': 'Proc. Jpn. Acad. Ser. B Phys. Biol. Sci.'},
{ 'issue': '2',
'key': '10.1016/j.clinpr.2022.100145_b0145',
'doi-asserted-by': 'crossref',
'first-page': '45',
'DOI': '10.1016/S2055-6640(20)30016-9',
'article-title': 'A review of the safety of favipiravir-a potential treatment in the '
'COVID-19 pandemic?',
'volume': '6',
'author': 'Pilkington',
'year': '2020',
'journal-title': 'J. Virus Erad.'},
{ 'issue': '2',
'key': '10.1016/j.clinpr.2022.100145_b0150',
'doi-asserted-by': 'crossref',
'first-page': '242',
'DOI': '10.1002/cpt.1844',
'article-title': 'Favipiravir: Pharmacokinetics and concerns about clinical trials for '
'2019-nCoV infection',
'volume': '108',
'author': 'Du',
'year': '2020',
'journal-title': 'Clinical Pharmacology and Therapeutics'}],
'container-title': 'Clinical Infection in Practice',
'original-title': [],
'language': 'en',
'link': [ { 'URL': 'https://api.elsevier.com/content/article/PII:S2590170222000139?httpAccept=text/xml',
'content-type': 'text/xml',
'content-version': 'vor',
'intended-application': 'text-mining'},
{ 'URL': 'https://api.elsevier.com/content/article/PII:S2590170222000139?httpAccept=text/plain',
'content-type': 'text/plain',
'content-version': 'vor',
'intended-application': 'text-mining'}],
'deposited': { 'date-parts': [[2022, 5, 12]],
'date-time': '2022-05-12T03:11:54Z',
'timestamp': 1652325114000},
'score': 1,
'resource': {'primary': {'URL': 'https://linkinghub.elsevier.com/retrieve/pii/S2590170222000139'}},
'subtitle': [],
'short-title': [],
'issued': {'date-parts': [[2022, 5]]},
'references-count': 30,
'alternative-id': ['S2590170222000139'],
'URL': 'http://dx.doi.org/10.1016/j.clinpr.2022.100145',
'relation': {},
'ISSN': ['2590-1702'],
'subject': ['General Medicine'],
'container-title-short': 'Clinical Infection in Practice',
'published': {'date-parts': [[2022, 5]]},
'article-number': '100145'}