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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 20211.
Hammond et al., 4 Apr 2024, peer-reviewed, 13 authors, trial NCT05011513 (history) (EPIC-SR).
This PaperPaxlovidAll
DOI record: { "DOI": "10.1056/nejmoa2309003", "ISSN": [ "0028-4793", "1533-4406" ], "URL": "http://dx.doi.org/10.1056/NEJMoa2309003", "alternative-id": [ "10.1056/NEJMoa2309003" ], "author": [ { "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": "Hammond", "given": "Jennifer", "sequence": "first" }, { "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": "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.); 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": "Fleishaker", "given": "Dona", "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": "Almas", "given": "Mary", "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": "Bao", "given": "Weihang", "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": "Wisemandle", "given": "Wayne", "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": "Baniecki", "given": "Mary Lynn", "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": "Hendrick", "given": "Victoria M.", "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": "Kalfov", "given": "Veselin", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0001-9630-7792", "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,..." } ], "authenticated-orcid": false, "family": "Simón-Campos", "given": "J. 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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). preprint." }, { "DOI": "10.1016/S0140-6736(22)01586-0", "doi-asserted-by": "publisher", "key": "e_1_3_5_14_2" }, { "DOI": "10.7326/M22-3565", "doi-asserted-by": "publisher", "key": "e_1_3_5_15_2" }, { "DOI": "10.1503/cmaj.221608", "doi-asserted-by": "publisher", "key": "e_1_3_5_16_2" }, { "DOI": "10.1056/NEJMoa2204919", "doi-asserted-by": "publisher", "key": "e_1_3_5_17_2" } ], "reference-count": 16, "references-count": 16, "relation": {}, "resource": { "primary": { "URL": "http://www.nejm.org/doi/10.1056/NEJMoa2309003" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [ "General Medicine" ], "subtitle": [], "title": "Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19", "type": "journal-article", "volume": "390" }
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