The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19
Abstract Objectives Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combinati...
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| Veröffentlicht in: | Journal of antimicrobial chemotherapy 2020-11, Vol.75 (11), p.3366-3372 |
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| creator | Eslami, Gholamali Mousaviasl, Sajedeh Radmanesh, Esmat Jelvay, Saeed Bitaraf, Saeid Simmons, Bryony Wentzel, Hannah Hill, Andrew Sadeghi, Anahita Freeman, James Salmanzadeh, Shokrollah Esmaeilian, Hani Mobarak, Morteza Tabibi, Ramin Jafari Kashi, Amir Hosein Lotfi, Zahra Talebzadeh, Seyed Mehdi Wickramatillake, Aseni Momtazan, Mahboobeh Hajizadeh Farsani, Majid Marjani, Sedigheh Mobarak, Sara |
| description | Abstract
Objectives
Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combination with daclatasvir in treating patients with COVID-19.
Methods
Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT–PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included. Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir/daclatasvir. All participants also received the recommended national standard treatment which, at that time, was lopinavir/ritonavir and single-dose hydroxychloroquine. The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality.
Results
Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm. The median duration of stay was 5 days for the sofosbuvir/daclatasvir group and 9 days for the ribavirin group. The mortality in the sofosbuvir/daclatasvir group was 2/35 (6%) and 9/27 (33%) for the ribavirin group. The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04–0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1–12.1, P |
| doi_str_mv | 10.1093/jac/dkaa331 |
| format | Article |
| fullrecord | <record><control><sourceid>oup_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7529105</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/jac/dkaa331</oup_id><sourcerecordid>10.1093/jac/dkaa331</sourcerecordid><originalsourceid>FETCH-LOGICAL-c440t-d376203b406c3e852890dab8fddf43d64ca88f79362bd17a692464c8da01b2923</originalsourceid><addsrcrecordid>eNp9kMtLAzEQxoMoWqsn75KTF1k7eewjF0Hqq1AoSPW6zCZZG227S7Kt-N8baS16EQZmmPnmm-FHyBmDKwZKDN5QD8w7ohBsj_SYzCDhoNg-6YGANMllKo7IcQhvAJClWXFIjgQvGIeU9cjTdGapW7SoO9rUNDR1E6rV2vmBQT3HDkOsaeOpdxXG0i1pjBY7Z5ddoB-um9Fg19ZbOpy8jG4Tpk7IQY3zYE-3uU-e7--mw8dkPHkYDW_GiZYSusSIPOMgKgmZFrZIeaHAYFXUxtRSmExqLIo6VyLjlWE5ZorL2CwMAqu44qJPrje-7apaWKPjQx7nZevdAv1n2aAr_06Wbla-NusyT7likEaDy42B9k0I3ta7XQblN9oyoi23aKP6_Pe5nfaHZRRcbATNqv3X6QuXQoNy</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><source>Free Full-Text Journals in Chemistry</source><creator>Eslami, Gholamali ; Mousaviasl, Sajedeh ; Radmanesh, Esmat ; Jelvay, Saeed ; Bitaraf, Saeid ; Simmons, Bryony ; Wentzel, Hannah ; Hill, Andrew ; Sadeghi, Anahita ; Freeman, James ; Salmanzadeh, Shokrollah ; Esmaeilian, Hani ; Mobarak, Morteza ; Tabibi, Ramin ; Jafari Kashi, Amir Hosein ; Lotfi, Zahra ; Talebzadeh, Seyed Mehdi ; Wickramatillake, Aseni ; Momtazan, Mahboobeh ; Hajizadeh Farsani, Majid ; Marjani, Sedigheh ; Mobarak, Sara</creator><creatorcontrib>Eslami, Gholamali ; Mousaviasl, Sajedeh ; Radmanesh, Esmat ; Jelvay, Saeed ; Bitaraf, Saeid ; Simmons, Bryony ; Wentzel, Hannah ; Hill, Andrew ; Sadeghi, Anahita ; Freeman, James ; Salmanzadeh, Shokrollah ; Esmaeilian, Hani ; Mobarak, Morteza ; Tabibi, Ramin ; Jafari Kashi, Amir Hosein ; Lotfi, Zahra ; Talebzadeh, Seyed Mehdi ; Wickramatillake, Aseni ; Momtazan, Mahboobeh ; Hajizadeh Farsani, Majid ; Marjani, Sedigheh ; Mobarak, Sara</creatorcontrib><description>Abstract
Objectives
Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combination with daclatasvir in treating patients with COVID-19.
Methods
Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT–PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included. Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir/daclatasvir. All participants also received the recommended national standard treatment which, at that time, was lopinavir/ritonavir and single-dose hydroxychloroquine. The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality.
Results
Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm. The median duration of stay was 5 days for the sofosbuvir/daclatasvir group and 9 days for the ribavirin group. The mortality in the sofosbuvir/daclatasvir group was 2/35 (6%) and 9/27 (33%) for the ribavirin group. The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04–0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1–12.1, P < 0.01).
Conclusions
Given these encouraging initial results, and the current lack of treatments proven to decrease mortality in COVID-19, further investigation in larger-scale trials seems warranted.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkaa331</identifier><identifier>PMID: 32812051</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adult ; Aged ; Antiviral Agents - administration & dosage ; Betacoronavirus ; Coronavirus Infections - drug therapy ; Coronavirus Infections - mortality ; COVID-19 ; Drug Therapy, Combination ; Female ; Humans ; Imidazoles - administration & dosage ; Male ; Middle Aged ; Original Research ; Pandemics ; Pneumonia, Viral - drug therapy ; Pneumonia, Viral - mortality ; Ribavirin - administration & dosage ; SARS-CoV-2 ; Sofosbuvir - administration & dosage ; Treatment Outcome</subject><ispartof>Journal of antimicrobial chemotherapy, 2020-11, Vol.75 (11), p.3366-3372</ispartof><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2020</rights><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-d376203b406c3e852890dab8fddf43d64ca88f79362bd17a692464c8da01b2923</citedby><cites>FETCH-LOGICAL-c440t-d376203b406c3e852890dab8fddf43d64ca88f79362bd17a692464c8da01b2923</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,1578,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32812051$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eslami, Gholamali</creatorcontrib><creatorcontrib>Mousaviasl, Sajedeh</creatorcontrib><creatorcontrib>Radmanesh, Esmat</creatorcontrib><creatorcontrib>Jelvay, Saeed</creatorcontrib><creatorcontrib>Bitaraf, Saeid</creatorcontrib><creatorcontrib>Simmons, Bryony</creatorcontrib><creatorcontrib>Wentzel, Hannah</creatorcontrib><creatorcontrib>Hill, Andrew</creatorcontrib><creatorcontrib>Sadeghi, Anahita</creatorcontrib><creatorcontrib>Freeman, James</creatorcontrib><creatorcontrib>Salmanzadeh, Shokrollah</creatorcontrib><creatorcontrib>Esmaeilian, Hani</creatorcontrib><creatorcontrib>Mobarak, Morteza</creatorcontrib><creatorcontrib>Tabibi, Ramin</creatorcontrib><creatorcontrib>Jafari Kashi, Amir Hosein</creatorcontrib><creatorcontrib>Lotfi, Zahra</creatorcontrib><creatorcontrib>Talebzadeh, Seyed Mehdi</creatorcontrib><creatorcontrib>Wickramatillake, Aseni</creatorcontrib><creatorcontrib>Momtazan, Mahboobeh</creatorcontrib><creatorcontrib>Hajizadeh Farsani, Majid</creatorcontrib><creatorcontrib>Marjani, Sedigheh</creatorcontrib><creatorcontrib>Mobarak, Sara</creatorcontrib><title>The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Abstract
Objectives
Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combination with daclatasvir in treating patients with COVID-19.
Methods
Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT–PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included. Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir/daclatasvir. All participants also received the recommended national standard treatment which, at that time, was lopinavir/ritonavir and single-dose hydroxychloroquine. The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality.
Results
Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm. The median duration of stay was 5 days for the sofosbuvir/daclatasvir group and 9 days for the ribavirin group. The mortality in the sofosbuvir/daclatasvir group was 2/35 (6%) and 9/27 (33%) for the ribavirin group. The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04–0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1–12.1, P < 0.01).
Conclusions
Given these encouraging initial results, and the current lack of treatments proven to decrease mortality in COVID-19, further investigation in larger-scale trials seems warranted.</description><subject>Adult</subject><subject>Aged</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Betacoronavirus</subject><subject>Coronavirus Infections - drug therapy</subject><subject>Coronavirus Infections - mortality</subject><subject>COVID-19</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Humans</subject><subject>Imidazoles - administration & dosage</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original Research</subject><subject>Pandemics</subject><subject>Pneumonia, Viral - drug therapy</subject><subject>Pneumonia, Viral - mortality</subject><subject>Ribavirin - administration & dosage</subject><subject>SARS-CoV-2</subject><subject>Sofosbuvir - administration & dosage</subject><subject>Treatment Outcome</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMtLAzEQxoMoWqsn75KTF1k7eewjF0Hqq1AoSPW6zCZZG227S7Kt-N8baS16EQZmmPnmm-FHyBmDKwZKDN5QD8w7ohBsj_SYzCDhoNg-6YGANMllKo7IcQhvAJClWXFIjgQvGIeU9cjTdGapW7SoO9rUNDR1E6rV2vmBQT3HDkOsaeOpdxXG0i1pjBY7Z5ddoB-um9Fg19ZbOpy8jG4Tpk7IQY3zYE-3uU-e7--mw8dkPHkYDW_GiZYSusSIPOMgKgmZFrZIeaHAYFXUxtRSmExqLIo6VyLjlWE5ZorL2CwMAqu44qJPrje-7apaWKPjQx7nZevdAv1n2aAr_06Wbla-NusyT7likEaDy42B9k0I3ta7XQblN9oyoi23aKP6_Pe5nfaHZRRcbATNqv3X6QuXQoNy</recordid><startdate>20201101</startdate><enddate>20201101</enddate><creator>Eslami, Gholamali</creator><creator>Mousaviasl, Sajedeh</creator><creator>Radmanesh, Esmat</creator><creator>Jelvay, Saeed</creator><creator>Bitaraf, Saeid</creator><creator>Simmons, Bryony</creator><creator>Wentzel, Hannah</creator><creator>Hill, Andrew</creator><creator>Sadeghi, Anahita</creator><creator>Freeman, James</creator><creator>Salmanzadeh, Shokrollah</creator><creator>Esmaeilian, Hani</creator><creator>Mobarak, Morteza</creator><creator>Tabibi, Ramin</creator><creator>Jafari Kashi, Amir Hosein</creator><creator>Lotfi, Zahra</creator><creator>Talebzadeh, Seyed Mehdi</creator><creator>Wickramatillake, Aseni</creator><creator>Momtazan, Mahboobeh</creator><creator>Hajizadeh Farsani, Majid</creator><creator>Marjani, Sedigheh</creator><creator>Mobarak, Sara</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20201101</creationdate><title>The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19</title><author>Eslami, Gholamali ; Mousaviasl, Sajedeh ; Radmanesh, Esmat ; Jelvay, Saeed ; Bitaraf, Saeid ; Simmons, Bryony ; Wentzel, Hannah ; Hill, Andrew ; Sadeghi, Anahita ; Freeman, James ; Salmanzadeh, Shokrollah ; Esmaeilian, Hani ; Mobarak, Morteza ; Tabibi, Ramin ; Jafari Kashi, Amir Hosein ; Lotfi, Zahra ; Talebzadeh, Seyed Mehdi ; Wickramatillake, Aseni ; Momtazan, Mahboobeh ; Hajizadeh Farsani, Majid ; Marjani, Sedigheh ; Mobarak, Sara</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c440t-d376203b406c3e852890dab8fddf43d64ca88f79362bd17a692464c8da01b2923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Betacoronavirus</topic><topic>Coronavirus Infections - drug therapy</topic><topic>Coronavirus Infections - mortality</topic><topic>COVID-19</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Humans</topic><topic>Imidazoles - administration & dosage</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original Research</topic><topic>Pandemics</topic><topic>Pneumonia, Viral - drug therapy</topic><topic>Pneumonia, Viral - mortality</topic><topic>Ribavirin - administration & dosage</topic><topic>SARS-CoV-2</topic><topic>Sofosbuvir - administration & dosage</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Eslami, Gholamali</creatorcontrib><creatorcontrib>Mousaviasl, Sajedeh</creatorcontrib><creatorcontrib>Radmanesh, Esmat</creatorcontrib><creatorcontrib>Jelvay, Saeed</creatorcontrib><creatorcontrib>Bitaraf, Saeid</creatorcontrib><creatorcontrib>Simmons, Bryony</creatorcontrib><creatorcontrib>Wentzel, Hannah</creatorcontrib><creatorcontrib>Hill, Andrew</creatorcontrib><creatorcontrib>Sadeghi, Anahita</creatorcontrib><creatorcontrib>Freeman, James</creatorcontrib><creatorcontrib>Salmanzadeh, Shokrollah</creatorcontrib><creatorcontrib>Esmaeilian, Hani</creatorcontrib><creatorcontrib>Mobarak, Morteza</creatorcontrib><creatorcontrib>Tabibi, Ramin</creatorcontrib><creatorcontrib>Jafari Kashi, Amir Hosein</creatorcontrib><creatorcontrib>Lotfi, Zahra</creatorcontrib><creatorcontrib>Talebzadeh, Seyed Mehdi</creatorcontrib><creatorcontrib>Wickramatillake, Aseni</creatorcontrib><creatorcontrib>Momtazan, Mahboobeh</creatorcontrib><creatorcontrib>Hajizadeh Farsani, Majid</creatorcontrib><creatorcontrib>Marjani, Sedigheh</creatorcontrib><creatorcontrib>Mobarak, Sara</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eslami, Gholamali</au><au>Mousaviasl, Sajedeh</au><au>Radmanesh, Esmat</au><au>Jelvay, Saeed</au><au>Bitaraf, Saeid</au><au>Simmons, Bryony</au><au>Wentzel, Hannah</au><au>Hill, Andrew</au><au>Sadeghi, Anahita</au><au>Freeman, James</au><au>Salmanzadeh, Shokrollah</au><au>Esmaeilian, Hani</au><au>Mobarak, Morteza</au><au>Tabibi, Ramin</au><au>Jafari Kashi, Amir Hosein</au><au>Lotfi, Zahra</au><au>Talebzadeh, Seyed Mehdi</au><au>Wickramatillake, Aseni</au><au>Momtazan, Mahboobeh</au><au>Hajizadeh Farsani, Majid</au><au>Marjani, Sedigheh</au><au>Mobarak, Sara</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2020-11-01</date><risdate>2020</risdate><volume>75</volume><issue>11</issue><spage>3366</spage><epage>3372</epage><pages>3366-3372</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><abstract>Abstract
Objectives
Sofosbuvir and daclatasvir are direct-acting antivirals highly effective against hepatitis C virus. There is some in silico and in vitro evidence that suggests these agents may also be effective against SARS-CoV-2. This trial evaluated the effectiveness of sofosbuvir in combination with daclatasvir in treating patients with COVID-19.
Methods
Patients with a positive nasopharyngeal swab for SARS-CoV-2 on RT–PCR or bilateral multi-lobar ground-glass opacity on their chest CT and signs of severe COVID-19 were included. Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir/daclatasvir. All participants also received the recommended national standard treatment which, at that time, was lopinavir/ritonavir and single-dose hydroxychloroquine. The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality.
Results
Sixty-two subjects met the inclusion criteria, with 35 enrolled in the sofosbuvir/daclatasvir arm and 27 in the ribavirin arm. The median duration of stay was 5 days for the sofosbuvir/daclatasvir group and 9 days for the ribavirin group. The mortality in the sofosbuvir/daclatasvir group was 2/35 (6%) and 9/27 (33%) for the ribavirin group. The relative risk of death for patients treated with sofosbuvir/daclatasvir was 0.17 (95% CI 0.04–0.73, P = 0.02) and the number needed to treat for benefit was 3.6 (95% CI 2.1–12.1, P < 0.01).
Conclusions
Given these encouraging initial results, and the current lack of treatments proven to decrease mortality in COVID-19, further investigation in larger-scale trials seems warranted.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>32812051</pmid><doi>10.1093/jac/dkaa331</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of antimicrobial chemotherapy, 2020-11, Vol.75 (11), p.3366-3372 |
| issn | 0305-7453 1460-2091 |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry |
| subjects | Adult Aged Antiviral Agents - administration & dosage Betacoronavirus Coronavirus Infections - drug therapy Coronavirus Infections - mortality COVID-19 Drug Therapy, Combination Female Humans Imidazoles - administration & dosage Male Middle Aged Original Research Pandemics Pneumonia, Viral - drug therapy Pneumonia, Viral - mortality Ribavirin - administration & dosage SARS-CoV-2 Sofosbuvir - administration & dosage Treatment Outcome |
| title | The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19 |
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