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Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19

Hammond et al., New England Journal of Medicine, doi:10.1056/NEJMoa2309003, EPIC-SR, NCT05011513
Apr 2024  
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Delayed publication for EPIC-SR showing no significant difference in time to sustained alleviation. Selected results were first made available in December 2021 Pfizer.
Hammond et al., 4 Apr 2024, peer-reviewed, 13 authors, trial NCT05011513 (history) (EPIC-SR).
This PaperPaxlovidAll
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' 'Global Product Development, Pfizer, Lexington, KY (D.F.); Global ' 'Product Development, Pfizer, New York (M.A., W.B., R.P.); Global ' 'Product Development, Pfizer, Lake Forest, IL (W.W.); Early ' 'Clinical Development, Pfizer, Cambridge, MA (M.L.B.); ' 'Pfizer,...'}], 'family': 'Fountaine', 'given': 'Robert J.', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'From Global Product Development, Pfizer, Collegeville, PA ' '(J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); ' 'Global Product Development, Pfizer, Lake Mary (C.Y.), and Global ' 'Product Development, Pfizer, Tampa (J.M.R.) — both in Florida; ' 'Global Product Development, Pfizer, Lexington, KY (D.F.); Global ' 'Product Development, Pfizer, New York (M.A., W.B., R.P.); Global ' 'Product Development, Pfizer, Lake Forest, IL (W.W.); Early ' 'Clinical Development, Pfizer, Cambridge, MA (M.L.B.); ' 'Pfizer,...'}], 'family': 'Yunis', 'given': 'Carla', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'From Global Product Development, Pfizer, Collegeville, PA ' '(J.H.); 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Fact sheet for healthcare providers: ' 'emergency use authorization for Paxlovid. 2024 ' '(https://labeling.pfizer.com/ShowLabeling.aspx?id=16474).'}, {'DOI': '10.1056/NEJMoa2118542', 'doi-asserted-by': 'publisher', 'key': 'e_1_3_5_10_2'}, { 'key': 'e_1_3_5_11_2', 'unstructured': 'Food and Drug Administration. FDA briefing document. Antimicrobial Drugs ' 'Advisory Committee meeting March 16 2023 ' '(https://www.fda.gov/media/166197/download).'}, { 'key': 'e_1_3_5_12_2', 'unstructured': 'Food and Drug Administration. Assessing COVID-19-related symptoms in ' 'outpatient adult and adolescent subjects in clinical trials of drugs and ' 'biological products for COVID-19 prevention or treatment. Guidance for ' 'industry. February 2024 ' '(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-covid-19-related-symptoms-outpatient-adult-and-adolescent-subjects-clinical-trials-drugs).'}, { 'DOI': '10.1101/2022.10.02.22280623', 'doi-asserted-by': 'crossref', 'key': 'e_1_3_5_13_2', 'unstructured': 'Lewnard JA McLaughlin JM Malden D et al. Effectiveness of ' 'nirmatrelvir-ritonavir against hospital admission or death: a cohort ' 'study in a large US healthcare system. January 10 2023 ' '(https://www.medrxiv.org/content/10.1101/2022.10.02.22280623v2). 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