Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19: Evidence from the US National COVID Cohort Collaborative (N3C)

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Available ' 'from: ' 'https://www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic. ' 'Accessed 6 December 2023.'}], 'container-title': 'Clinical Drug Investigation', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1007/s40261-024-01344-4.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1007/s40261-024-01344-4/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1007/s40261-024-01344-4.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 2, 20]], 'date-time': '2024-02-20T20:09:00Z', 'timestamp': 1708459740000}, 'score': 1, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s40261-024-01344-4'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2024, 2, 20]]}, 'references-count': 54, 'alternative-id': ['1344'], 'URL': 'http://dx.doi.org/10.1007/s40261-024-01344-4', 'relation': {}, 'ISSN': ['1173-2563', '1179-1918'], 'subject': ['Pharmacology (medical)', 'General Medicine'], 'container-title-short': 'Clin Drug Investig', 'published': {'date-parts': [[2024, 2, 20]]}, 'assertion': [ { 'value': '17 January 2024', 'order': 1, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '20 February 2024', 'order': 2, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'This study was funded by GSK (study number 219020) and Vir Biotechnology, Inc.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Funding'}}, { 'value': 'All named authors take responsibility for the integrity of the work as a whole ' 'and have given their approval for this version to be published. The content is ' 'solely the responsibility of the authors and does not necessarily represent the ' 'official views of the National Institutes of Health.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Authorship'}}, { 'value': 'All authors made a significant contribution to the work reported, whether that ' 'was in the conception, study design, execution, acquisition of data, analysis ' 'and interpretation, or in all these areas; took part in drafting, revising or ' 'critically reviewing the manuscript; gave final approval of the version to be ' 'published; have agreed on the journal to which the article has been submitted; ' 'and agree to be accountable for all aspects of the work.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Author Contributions'}}, { 'value': 'CFB, DCG, EJL, HJB, MD and VP (at time of study): employees of, and/or ' 'shareholders in, GSK. AZ, MDS, MSD, PB and RD: employees of Analysis Group, ' 'which received funding from GSK to conduct the study.', 'order': 5, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Conflict of Interest'}}, { 'value': 'This study complies with all applicable laws regarding subject privacy. No ' 'direct subject contact or primary collection of individual human subject data ' 'occurred. Study results were in tabular form, and aggregate analyses that omit ' 'subject identification, therefore, informed consent, ethics committee or ' 'institutional review board (IRB) were not required. However, use of the N3C ' 'Limited Dataset did require review and approval by WCG IRB (IRB study number: ' '1332048/IRB tracking number: 20222051). Any publications and reports do not ' 'include subject identifiers.', 'order': 6, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics Approval'}}, { 'value': 'Not applicable (see explanation in ‘Ethics approval’ section above).', 'order': 7, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent to Participate'}}, { 'value': 'Not applicable.', 'order': 8, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for Publication'}}, { 'value': 'Data archiving is not mandated but will be made available upon reasonable ' 'request.', 'order': 9, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Availability of Data and Material'}}, { 'value': 'Not applicable.', 'order': 10, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Code Availability'}}]}