Randomized Controlled Open Label Trial on the Use of Favipiravir Combined with Inhaled Interferon beta-1b in Hospitalized Patients with Moderate to Severe COVID-19 Pneumonia

DOI record: { "DOI": "10.1016/j.ijid.2020.11.008", "ISSN": [ "1201-9712" ], "URL": "http://dx.doi.org/10.1016/j.ijid.2020.11.008", "alternative-id": [ "S1201971220323195" ], "assertion": [ { "label": "This article is maintained by", "name": "publisher", "value": "Elsevier" }, { "label": "Article Title", "name": "articletitle", "value": "Randomized controlled open label trial on the use of favipiravir combined with inhaled interferon beta-1b in hospitalized patients with moderate to severe COVID-19 pneumonia" }, { "label": "Journal Title", "name": "journaltitle", "value": "International Journal of Infectious Diseases" }, { "label": "CrossRef DOI link to publisher maintained version", "name": "articlelink", "value": "https://doi.org/10.1016/j.ijid.2020.11.008" }, { "label": "Content Type", "name": "content_type", "value": "article" }, { "label": "Copyright", "name": "copyright", "value": "© 2020 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases." } ], "author": [ { "ORCID": "http://orcid.org/0000-0002-5107-921X", "affiliation": [], "authenticated-orcid": false, "family": "Khamis", "given": "Faryal", "sequence": "first" }, { "affiliation": [], "family": "Al Naabi", "given": "Hanan", "sequence": "additional" }, { "affiliation": [], "family": "Al Lawati", "given": "Adil", "sequence": "additional" }, { "affiliation": [], "family": "Ambusaidi", "given": "Zaiyana", "sequence": "additional" }, { "affiliation": [], "family": "Al Sharji", "given": "Mariam", "sequence": "additional" }, { "affiliation": [], "family": "Al Barwani", "given": "Umkulthum", "sequence": "additional" }, { "affiliation": [], "family": "Pandak", "given": "Nenad", "sequence": "additional" }, { "affiliation": [], "family": "Al Balushi", "given": "Zakariya", "sequence": "additional" }, { "affiliation": [], "family": "Al Bahrani", "given": "Maher", "sequence": "additional" }, { "affiliation": [], "family": "Al Salmi", "given": "Issa", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-3626-4230", "affiliation": [], "authenticated-orcid": false, "family": "Al-Zakwani", "given": "Ibrahim", "sequence": "additional" } ], "container-title": [ "International Journal of Infectious Diseases" ], "content-domain": { "crossmark-restriction": true, "domain": [ "ijidonline.com", "clinicalkey.jp", "clinicalkey.com", "clinicalkey.es", "clinicalkey.fr", "clinicalkey.com.au", "elsevier.com", "sciencedirect.com" ] }, "created": { "date-parts": [ [ 2020, 11, 9 ] ], "date-time": "2020-11-09T18:08:21Z", "timestamp": 1604945301000 }, "deposited": { "date-parts": [ [ 2021, 4, 21 ] ], "date-time": "2021-04-21T21:32:08Z", "timestamp": 1619040728000 }, "indexed": { "date-parts": [ [ 2022, 1, 10 ] ], "date-time": "2022-01-10T12:28:10Z", "timestamp": 1641817690526 }, "is-referenced-by-count": 29, "issn-type": [ { "type": "print", "value": "1201-9712" } ], "issued": { "date-parts": [ [ 2021, 1 ] ] }, "language": "en", "license": [ { "URL": "https://www.elsevier.com/tdm/userlicense/1.0/", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2021, 1, 1 ] ], "date-time": "2021-01-01T00:00:00Z", "timestamp": 1609459200000 } }, { "URL": "http://creativecommons.org/licenses/by-nc-nd/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2020, 11, 4 ] ], "date-time": "2020-11-04T00:00:00Z", "timestamp": 1604448000000 } } ], "link": [ { "URL": "https://api.elsevier.com/content/article/PII:S1201971220323195?httpAccept=text/xml", "content-type": "text/xml", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://api.elsevier.com/content/article/PII:S1201971220323195?httpAccept=text/plain", "content-type": "text/plain", "content-version": "vor", "intended-application": "text-mining" } ], "member": "78", "original-title": [], "page": "538-543", "prefix": "10.1016", "published": { "date-parts": [ [ 2021, 1 ] ] }, "published-print": { "date-parts": [ [ 2021, 1 ] ] }, "publisher": "Elsevier BV", "reference": [ { "DOI": "10.1016/j.mjafi.2020.08.004", "article-title": "Favipiravir: a new and emerging antiviral option in COVID-19", "author": "Agrawal", "doi-asserted-by": "crossref", "journal-title": "Med J Armed Forces India", "key": "10.1016/j.ijid.2020.11.008_bib0005", "year": "2020" }, { "article-title": "Experimental Treatment with Favipiravir for COVID-19: an Open-Label Control Study [published online ahead of print, 2020 Mar 18]", "author": "Cai", "journal-title": "Engineering (Beijing)", "key": "10.1016/j.ijid.2020.11.008_bib0010", "year": "2020" }, { "DOI": "10.1186/s13054-020-03078-z", "article-title": "COVID-UTH Study Group. Nafamostat mesylate treatment in combination with favipiravir for patients critically ill with Covid-19: a case series", "author": "Doi", "doi-asserted-by": "crossref", "first-page": "392", "issue": "1", "journal-title": "Crit Care", "key": "10.1016/j.ijid.2020.11.008_bib0015", "volume": "24", "year": "2020" }, { "DOI": "10.5582/ddt.2020.01012", "article-title": "Discovering drugs to treat coronavirus disease 2019 (COVID-19)", "author": "Dong", "doi-asserted-by": "crossref", "first-page": "58", "issue": "1", "journal-title": "Drug Discov Ther", "key": "10.1016/j.ijid.2020.11.008_bib0020", "volume": "14", "year": "2020" }, { "DOI": "10.1016/j.bsheal.2020.04.004", "article-title": "Advanced researches on the inhibition of influenza virus by Favipiravir and Baloxavir", "author": "Fang", "doi-asserted-by": "crossref", "first-page": "64", "issue": "2", "journal-title": "Biosafety Health", "key": "10.1016/j.ijid.2020.11.008_bib0025", "volume": "2", "year": "2020" }, { "DOI": "10.1017/S0317167100014244", "article-title": "Treatment optimization in MS: Canadian MS Working Group updated recommendations", "author": "Freedman", "doi-asserted-by": "crossref", "first-page": "307", "issue": "3", "journal-title": "Can J Neurol Sci", "key": "10.1016/j.ijid.2020.11.008_bib0030", "volume": "40", "year": "2013" }, { "article-title": "A clinical pilot study on the safety and efficacy of aerosol inhalation treatment of IFN-κ plus TFF2 in patients with moderate COVID-19", "author": "Fu", "journal-title": "E Clin Med", "key": "10.1016/j.ijid.2020.11.008_bib0035", "volume": "25", "year": "2020" }, { "DOI": "10.1016/j.antiviral.2013.09.015", "article-title": "Favipiravir (T-705), a novel viral RNA polymerase inhibitor", "author": "Furuta", "doi-asserted-by": "crossref", "first-page": "446", "issue": "2", "journal-title": "Antiviral Res", "key": "10.1016/j.ijid.2020.11.008_bib0040", "volume": "100", "year": "2013" }, { "DOI": "10.1056/NEJMoa2012410", "article-title": "Observational study on hydroxychloroquine in hospitalized patients with COVID-19", "author": "Geleris", "doi-asserted-by": "crossref", "first-page": "2411", "journal-title": "N Engl J Med", "key": "10.1016/j.ijid.2020.11.008_bib0045", "volume": "382", "year": "2020" }, { "DOI": "10.1002/psp4.12543", "article-title": "Timing of Antiviral Treatment Initiation is Critical to Reduce SARS-CoV-2 Viral", "author": "Gonçalves", "doi-asserted-by": "crossref", "first-page": "509", "issue": "9", "journal-title": "CPT Pharmacometrics Syst Pharmacol", "key": "10.1016/j.ijid.2020.11.008_bib0050", "volume": "9", "year": "2020" }, { "DOI": "10.1016/S0140-6736(20)31042-4", "article-title": "Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial", "author": "Hung", "doi-asserted-by": "crossref", "first-page": "1695", "issue": "10238", "journal-title": "Lancet", "key": "10.1016/j.ijid.2020.11.008_bib0055", "volume": "395", "year": "2020" }, { "DOI": "10.1016/j.clinthera.2008.06.013", "article-title": "Tolerability and safety profile of 12- to 28-week treatment with interferon beta-1b 250 and 500 microg QOD in patients with relapsing-remitting multiple sclerosis: a multicenter, randomized, double-blind, parallel-group pilot study", "author": "Hurwitz", "doi-asserted-by": "crossref", "first-page": "1102", "issue": "6", "journal-title": "Clin Ther", "key": "10.1016/j.ijid.2020.11.008_bib0060", "volume": "30", "year": "2008" }, { "DOI": "10.1073/pnas.2014441117", "article-title": "Favipiravir at high doses has potent antiviral activity in SARS-CoV-2-infected hamsters, whereas hydroxychloroquine lacks activity", "author": "Kaptein", "doi-asserted-by": "crossref", "first-page": "26955", "issue": "43", "journal-title": "Proct Natl Acad Sci USA", "key": "10.1016/j.ijid.2020.11.008_bib0065", "volume": "117", "year": "2020" }, { "DOI": "10.5001/omj.2020.60", "article-title": "Epidemiology of COVID-19 infection in Oman: analysis of the first 1304 cases", "author": "Khamis", "doi-asserted-by": "crossref", "first-page": "141", "issue": "3", "journal-title": "Oman Med J", "key": "10.1016/j.ijid.2020.11.008_bib0070", "volume": "35", "year": "2020" }, { "article-title": "Pipeline Pharmacological Therapies in Clinical Trial for COVID-19 Pandemic: a Recent Update", "author": "Kumari", "first-page": "1", "journal-title": "Curr Pharmacol Rep", "key": "10.1016/j.ijid.2020.11.008_bib0075", "year": "2020" }, { "DOI": "10.1007/s00415-013-6888-0", "article-title": "Efficacy and safety of interferon beta-1b sc in older RRMS patients--a posthoc analysis of the BEYOND study", "author": "Lampl", "doi-asserted-by": "crossref", "first-page": "1838", "issue": "7", "journal-title": "J Neurol", "key": "10.1016/j.ijid.2020.11.008_bib0080", "volume": "260", "year": "2013" }, { "DOI": "10.1016/j.jmii.2020.02.001", "article-title": "Emerging threats from zoonotic coronaviruses-from SARS and MERS to 2019-nCoV", "author": "Lee", "doi-asserted-by": "crossref", "first-page": "365", "issue": "3", "journal-title": "J Microbiol Immunol Infect", "key": "10.1016/j.ijid.2020.11.008_bib0085", "volume": "53", "year": "2020" }, { "DOI": "10.1128/JVI.01410-20", "article-title": "Type I interferon susceptibility distinguishes SARS-CoV-2 from SARS-CoV", "author": "Lokugamage", "doi-asserted-by": "crossref", "journal-title": "J Virol", "key": "10.1016/j.ijid.2020.11.008_bib0090", "year": "2020" }, { "DOI": "10.5582/bst.2020.01020", "article-title": "Drug treatment options for the 2019-new coronavirus (2019-nCoV)", "author": "Lu", "doi-asserted-by": "crossref", "first-page": "69", "issue": "1", "journal-title": "Biosci Trends", "key": "10.1016/j.ijid.2020.11.008_bib0095", "volume": "14", "year": "2020" }, { "DOI": "10.1007/s40262-015-0364-1", "article-title": "Ebola Virus Infection: Review of the Pharmacokinetic and Pharmacodynamic Properties of Drugs Considered for Testing in Human Efficacy Trials", "author": "Madelain", "doi-asserted-by": "crossref", "first-page": "907", "issue": "8", "journal-title": "Clin Pharmacokinet", "key": "10.1016/j.ijid.2020.11.008_bib0100", "volume": "55", "year": "2016" }, { "DOI": "10.1016/j.antiviral.2015.08.015", "article-title": "Ebola virus dynamics in mice treated with favipiravir", "author": "Madelain", "doi-asserted-by": "crossref", "first-page": "70", "journal-title": "Antiviral Res", "key": "10.1016/j.ijid.2020.11.008_bib0105", "volume": "123", "year": "2015" }, { "DOI": "10.1371/journal.pntd.0008259", "article-title": "The safety profile of favipiravir should not be the first argument to suspend its evaluation in viral hemorrhagic fevers", "author": "Malvy", "doi-asserted-by": "crossref", "issue": "6", "journal-title": "PLoS Negl Trop Dis", "key": "10.1016/j.ijid.2020.11.008_bib0110", "volume": "14", "year": "2020" }, { "author": "MDVI, LLC", "key": "10.1016/j.ijid.2020.11.008_bib0115", "series-title": "Phase 3 efficacy and safety study of favipiravir for treatment of uncomplicated influenza in adults", "year": "2020" }, { "DOI": "10.1016/S1473-3099(14)71047-3", "article-title": "Dose regimen of favipiravir for Ebola virus disease", "author": "Mentré", "doi-asserted-by": "crossref", "first-page": "150", "issue": "2", "journal-title": "Lancet Infect Dis", "key": "10.1016/j.ijid.2020.11.008_bib0120", "volume": "15", "year": "2015" }, { "author": "Ministry of Health Oman", "key": "10.1016/j.ijid.2020.11.008_bib0125", "series-title": "Number of registered corona virus (COVID-19): Cases in Oman-update", "year": "2020" }, { "DOI": "10.1016/S0140-6736(03)14484-4", "article-title": "Treatment of SARS with human interferons", "author": "Moriguchi", "doi-asserted-by": "crossref", "first-page": "1159", "issue": "9390", "journal-title": "Lancet", "key": "10.1016/j.ijid.2020.11.008_bib0130", "volume": "362", "year": "2003" }, { "DOI": "10.1371/journal.pntd.0005389", "article-title": "Favipiravir pharmacokinetics in Ebola-Infected patients of the JIKI trial reveals concentrations lower than targeted", "author": "Nguyen", "doi-asserted-by": "crossref", "issue": "2", "journal-title": "PLoS Negl Trop Dis", "key": "10.1016/j.ijid.2020.11.008_bib0135", "volume": "11", "year": "2017" }, { "DOI": "10.1016/j.antiviral.2014.02.014", "article-title": "Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in a small animal model", "author": "Oestereich", "doi-asserted-by": "crossref", "first-page": "17", "journal-title": "Antiviral Res", "key": "10.1016/j.ijid.2020.11.008_bib0140", "volume": "105", "year": "2014" }, { "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?", "author": "Pilkington", "doi-asserted-by": "crossref", "first-page": "45", "issue": "2", "journal-title": "J Virus Erad", "key": "10.1016/j.ijid.2020.11.008_bib0145", "volume": "6", "year": "2020" }, { "DOI": "10.1016/j.antiviral.2020.104791", "article-title": "Type 1 interferons as a potential treatment against COVID-19", "author": "Sallard", "doi-asserted-by": "crossref", "journal-title": "Antiviral Res", "key": "10.1016/j.ijid.2020.11.008_bib0150", "volume": "178", "year": "2020" }, { "author": "Saudi Ministry of Health", "key": "10.1016/j.ijid.2020.11.008_bib0155", "series-title": "Coronavirus Diseases 19 (COVID-19) Protocol for Patients Suspected Confirmed with COVID-9. Supportive care and antiviral treatment of suspected or confirmed COVID-19 infection", "year": "2020" }, { "DOI": "10.1016/S0140-6736(20)31101-6", "article-title": "Interferon beta-1b for COVID-19", "author": "Shalhoub", "doi-asserted-by": "crossref", "first-page": "1670", "issue": "10238", "journal-title": "Lancet", "key": "10.1016/j.ijid.2020.11.008_bib0160", "volume": "395", "year": "2020" }, { "DOI": "10.1016/j.pharmthera.2020.107512", "article-title": "Favipiravir, an anti-influenza drug against life-threatening RNA virus infections", "author": "Shiraki", "doi-asserted-by": "crossref", "journal-title": "Pharmacol Ther", "key": "10.1016/j.ijid.2020.11.008_bib0165", "volume": "209", "year": "2020" }, { "DOI": "10.1371/journal.pmed.1001967", "article-title": "Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea", "author": "Sissoko", "doi-asserted-by": "crossref", "first-page": "e1001967", "issue": "3", "journal-title": "PLoS Med", "key": "10.1016/j.ijid.2020.11.008_bib0170", "volume": "13", "year": "2016" }, { "DOI": "10.1111/bcp.14314", "article-title": "Dosing will be a key success factor in repurposing antivirals for COVID‐19", "author": "Smith", "doi-asserted-by": "crossref", "journal-title": "Br J Clin Pharmacol", "key": "10.1016/j.ijid.2020.11.008_bib0175", "year": "2020" }, { "article-title": "Hydroxychloroquine in patients mainly with mild to moderate COVID-19: an open-label, randomised, controlled trial", "author": "Tang", "journal-title": "BMJ", "key": "10.1016/j.ijid.2020.11.008_bib0180", "volume": "369", "year": "2020" }, { "author": "United Arab Emirates Ministry of Health and Prevention", "key": "10.1016/j.ijid.2020.11.008_bib0185", "series-title": "National Guidelines for Clinical Management and Treatment of COVID-19", "year": "2020" }, { "author": "World Health Organization", "key": "10.1016/j.ijid.2020.11.008_bib0190", "series-title": "WHO declares COVID-19 as a global pandemic", "year": "2020" } ], "reference-count": 38, "references-count": 38, "relation": {}, "score": 1, "short-container-title": [ "International Journal of Infectious Diseases" ], "short-title": [], "source": "Crossref", "subject": [ "Infectious Diseases", "Microbiology (medical)", "General Medicine" ], "subtitle": [], "title": [ "Randomized controlled open label trial on the use of favipiravir combined with inhaled interferon beta-1b in hospitalized patients with moderate to severe COVID-19 pneumonia" ], "type": "journal-article", "update-policy": "http://dx.doi.org/10.1016/elsevier_cm_policy", "volume": "102" }