Safety, Pharmacokinetics, and Predicted Neutralizing Activity of the SARS-CoV-2 Monoclonal Antibody Sipavibart: Results from Little DIPPER and the SUPERNOVA Substudy

DOI record: { "DOI": "10.1007/s40121-026-01423-3", "ISSN": [ "2193-8229", "2193-6382" ], "URL": "http://dx.doi.org/10.1007/s40121-026-01423-3", "alternative-id": [ "1423" ], "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "27 March 2026" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "21 July 2026" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "7 September 2026" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Conflict of Interest", "name": "Ethics", "order": 1, "value": "Huixia Zhang, Lindsay Clegg, Yue Chang, Anastasia A. Aksyuk, Dave Francisco, Sambuddha Ghosh, Karina Soboleva, Aashima Puri, Mayur Ramesh, Lee-Jah Chang, and Taylor S. Cohen are employees of and may hold stock and/or stock options in AstraZeneca. Sam Matthews was an employee of and received a salary from Exploristics Ltd, and was contracted to AstraZeneca at the time of the studies; and is currently an employee of and receives a salary from Cytel Inc, and is contracted to AstraZeneca. Michael Gibbs was an employee of and may have held stock and/or stock options in AstraZeneca at the time of the studies." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Ethical Approval", "name": "Ethics", "order": 2, "value": "Both studies adhered to the ethical principles originating in the Declaration of Helsinki, International Council for Harmonisation Good Clinical Practice guidelines, and to AstraZeneca policy on Bioethics and Human Biological Samples. The protocols and other relevant documents were reviewed and approved by a central institutional review board (Little DIPPER: Advarra IRB, 6100 Merriweather Drive, Suite 600, Columbia, MD 21044, USA; SUPERNOVA substudy: WCG IRB, 212 Carnegie Center, Suite 301, Princeton, NJ 8540, USA). 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