Ensitrelvir for the treatment of hospitalized adults with COVID-19: an international phase 3 randomized placebo-controlled trial.
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| Title: | Ensitrelvir for the treatment of hospitalized adults with COVID-19: an international phase 3 randomized placebo-controlled trial. |
|---|---|
| Authors: | Baker JV; Infectious Diseases, Hennepin Healthcare, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA., Siegel L; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA., Losso M; CICAL, Fundación IBIS, Buenos Aires, Argentina.; Hospital General de Agudos Jose Maria Ramos Mejía, Buenos Aires, Argentina., Vasudeva S; Virginia Tech Carilion School of Medicine, Salem, Virginia, USA.; Department of Medicine, Salem VA Medical Center, U.S. Department of Veterans Affairs, Salem, Virginia, USA., Nordwall JA; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA., Harper K; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA., Grund B; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA., Havens JP; College of Pharmacy, University of Nebraska Medical Center, Omaha, Nebraska, USA., Fletcher CV; Antiviral Pharmacology Laboratory, University of Nebraska Medical Center, Omaha, Nebraska, USA., Fishchuk R; Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Ukraine., Kobrynska O; Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Ukraine., Abutidze A; T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia., Metchurtchlishvili R; T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia., Ginde A; Department of Emergency Medicine, University of Colorado Anschutz, School of Medicine, Aurora, Colorado, USA., Aggarwal NR; Division of Pulmonary, Allergy, and Critical Care Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA., Poulakou G; National and Kapodistrian University of Athens, Medical School, Athens, Greece., Mourad A; Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.; Duke Clinical Research Institute, Durham, North Carolina, USA., Gibbs K; Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA., Saito S; Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan Institute for Health Society, Toyama, Shinjuku-ku, Tokyo, Japan., Chayakulkeeree M; Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand., Mootsikapun P; Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand., Honda H; Department of Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Nagoya, Japan., Mateu L; Department of Infectious Diseases, Hospital Germans Trias i Pujol, Fundacio Lluita contra les Infeccions, Badalona, Spain., Gyrina O; Treatment and Diagnostic Center ADONIS Plus, Kyiv, Ukraine., Garcia A; University of Texas Southwestern Medical Center, Dallas, Texas, USA., Lee DG; Division of Infectious Diseases, Department of Internal Medicine, The Catholic University of Korea, Seoul, Republic of Korea., Casey JD; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville Tennessee, USA.; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville Tennessee, USA., Jain MK; University of Texas Southwestern, Parkland Health, Dallas, Texas, USA., Bengtson CD; Division of Pulmonary Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA., Hite RD; University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Hiranburana N; HIV-NAT, Thai Red Cross AIDS and Infectious Diseases Research Centre, Bangkok, Thailand.; Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand., Matthay M; Cardiovascular Research Institute, Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco, California, USA., Arizmendez N; Intermountain Health, University of Utah School of Medicine, Murray, Utah, USA., Nguyen HH; VA Northern California Health Care System, UC Davis Health, Sacramento, California, USA., Drelick A; New York Presbyterian Weill Cornell Medical Center, New York, New York, USA., Mena Lora AJ; University of Illinois Chicago, Chicago, Illinois, USA., Parnia S; New York University Grossman School of Medicine, New York, New York, USA., Trautner BW; Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA., Portsmouth SD; Shionogi Inc., Florham Park, New Jersey, USA., Shimizu R; Shionogi & Co., Ltd., Osaka, Japan., Uehara T; Drug Development and Regulatory Division, Shionogi & Co., Ltd., Osaka, Japan., Paredes R; Department of Infectious Diseases & irsiCaixa, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain., Goodman A; MRC Clinical Trials Unit at University College London, London, United Kingdom.; Department of Infection at Guy's and St. Thomas' Hospital and King's College London, London, United Kingdom., Vock DM; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA., Gelijns AC; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Weintrob AC; Washington, DC Veteran Affairs Medical Center, Washington, DC, USA., Bajema KL; Veterans Affairs Portland Health Care System, Portland, Oregon, USA.; Division of Infectious Diseases, Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA., Pett SL; MRC Clinical Trials Unit at University College London, London, United Kingdom., Lundgren J; Department of Infectious Diseases, Centre of Excellence in Health Immunity and Infection, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Schechner AJ; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA., Higgs ES; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA., Lane HC; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA., Matthews GV; Kirby Institute, University of New South Wales, Sydney, Australia., Self WH; Vanderbilt Institute for Clinical and Translational Research Nashville, Vanderbilt University Medical Center, Tennessee, USA.; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Reilly C; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA. |
| Source: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2026 Apr 22. Date of Electronic Publication: 2026 Apr 22. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 42017206 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Ensitrelvir for the treatment of hospitalized adults with COVID-19: an international phase 3 randomized placebo-controlled trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Baker+JV%22">Baker JV</searchLink>; Infectious Diseases, Hennepin Healthcare, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.<br /><searchLink fieldCode="AU" term="%22Siegel+L%22">Siegel L</searchLink>; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.<br /><searchLink fieldCode="AU" term="%22Losso+M%22">Losso M</searchLink>; CICAL, Fundación IBIS, Buenos Aires, Argentina.; Hospital General de Agudos Jose Maria Ramos Mejía, Buenos Aires, Argentina.<br /><searchLink fieldCode="AU" term="%22Vasudeva+S%22">Vasudeva S</searchLink>; Virginia Tech Carilion School of Medicine, Salem, Virginia, USA.; Department of Medicine, Salem VA Medical Center, U.S. Department of Veterans Affairs, Salem, Virginia, USA.<br /><searchLink fieldCode="AU" term="%22Nordwall+JA%22">Nordwall JA</searchLink>; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.<br /><searchLink fieldCode="AU" term="%22Harper+K%22">Harper K</searchLink>; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.<br /><searchLink fieldCode="AU" term="%22Grund+B%22">Grund B</searchLink>; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.<br /><searchLink fieldCode="AU" term="%22Havens+JP%22">Havens JP</searchLink>; College of Pharmacy, University of Nebraska Medical Center, Omaha, Nebraska, USA.<br /><searchLink fieldCode="AU" term="%22Fletcher+CV%22">Fletcher CV</searchLink>; Antiviral Pharmacology Laboratory, University of Nebraska Medical Center, Omaha, Nebraska, USA.<br /><searchLink fieldCode="AU" term="%22Fishchuk+R%22">Fishchuk R</searchLink>; Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Ukraine.<br /><searchLink fieldCode="AU" term="%22Kobrynska+O%22">Kobrynska O</searchLink>; Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Ukraine.<br /><searchLink fieldCode="AU" term="%22Abutidze+A%22">Abutidze A</searchLink>; T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia.<br /><searchLink fieldCode="AU" term="%22Metchurtchlishvili+R%22">Metchurtchlishvili R</searchLink>; T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia.<br /><searchLink fieldCode="AU" term="%22Ginde+A%22">Ginde A</searchLink>; Department of Emergency Medicine, University of Colorado Anschutz, School of Medicine, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Aggarwal+NR%22">Aggarwal NR</searchLink>; Division of Pulmonary, Allergy, and Critical Care Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Poulakou+G%22">Poulakou G</searchLink>; National and Kapodistrian University of Athens, Medical School, Athens, Greece.<br /><searchLink fieldCode="AU" term="%22Mourad+A%22">Mourad A</searchLink>; Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.; Duke Clinical Research Institute, Durham, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Gibbs+K%22">Gibbs K</searchLink>; Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Saito+S%22">Saito S</searchLink>; Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan Institute for Health Society, Toyama, Shinjuku-ku, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Chayakulkeeree+M%22">Chayakulkeeree M</searchLink>; Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.<br /><searchLink fieldCode="AU" term="%22Mootsikapun+P%22">Mootsikapun P</searchLink>; Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.<br /><searchLink fieldCode="AU" term="%22Honda+H%22">Honda H</searchLink>; Department of Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Nagoya, Japan.<br /><searchLink fieldCode="AU" term="%22Mateu+L%22">Mateu L</searchLink>; Department of Infectious Diseases, Hospital Germans Trias i Pujol, Fundacio Lluita contra les Infeccions, Badalona, Spain.<br /><searchLink fieldCode="AU" term="%22Gyrina+O%22">Gyrina O</searchLink>; Treatment and Diagnostic Center ADONIS Plus, Kyiv, Ukraine.<br /><searchLink fieldCode="AU" term="%22Garcia+A%22">Garcia A</searchLink>; University of Texas Southwestern Medical Center, Dallas, Texas, USA.<br /><searchLink fieldCode="AU" term="%22Lee+DG%22">Lee DG</searchLink>; Division of Infectious Diseases, Department of Internal Medicine, The Catholic University of Korea, Seoul, Republic of Korea.<br /><searchLink fieldCode="AU" term="%22Casey+JD%22">Casey JD</searchLink>; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville Tennessee, USA.; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville Tennessee, USA.<br /><searchLink fieldCode="AU" term="%22Jain+MK%22">Jain MK</searchLink>; University of Texas Southwestern, Parkland Health, Dallas, Texas, USA.<br /><searchLink fieldCode="AU" term="%22Bengtson+CD%22">Bengtson CD</searchLink>; Division of Pulmonary Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.<br /><searchLink fieldCode="AU" term="%22Hite+RD%22">Hite RD</searchLink>; University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.<br /><searchLink fieldCode="AU" term="%22Hiranburana+N%22">Hiranburana N</searchLink>; HIV-NAT, Thai Red Cross AIDS and Infectious Diseases Research Centre, Bangkok, Thailand.; Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.<br /><searchLink fieldCode="AU" term="%22Matthay+M%22">Matthay M</searchLink>; Cardiovascular Research Institute, Departments of Medicine and Anesthesia, University of California, San Francisco, San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Arizmendez+N%22">Arizmendez N</searchLink>; Intermountain Health, University of Utah School of Medicine, Murray, Utah, USA.<br /><searchLink fieldCode="AU" term="%22Nguyen+HH%22">Nguyen HH</searchLink>; VA Northern California Health Care System, UC Davis Health, Sacramento, California, USA.<br /><searchLink fieldCode="AU" term="%22Drelick+A%22">Drelick A</searchLink>; New York Presbyterian Weill Cornell Medical Center, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Mena+Lora+AJ%22">Mena Lora AJ</searchLink>; University of Illinois Chicago, Chicago, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Parnia+S%22">Parnia S</searchLink>; New York University Grossman School of Medicine, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Trautner+BW%22">Trautner BW</searchLink>; Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.<br /><searchLink fieldCode="AU" term="%22Portsmouth+SD%22">Portsmouth SD</searchLink>; Shionogi Inc., Florham Park, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Shimizu+R%22">Shimizu R</searchLink>; Shionogi & Co., Ltd., Osaka, Japan.<br /><searchLink fieldCode="AU" term="%22Uehara+T%22">Uehara T</searchLink>; Drug Development and Regulatory Division, Shionogi & Co., Ltd., Osaka, Japan.<br /><searchLink fieldCode="AU" term="%22Paredes+R%22">Paredes R</searchLink>; Department of Infectious Diseases & irsiCaixa, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.<br /><searchLink fieldCode="AU" term="%22Goodman+A%22">Goodman A</searchLink>; MRC Clinical Trials Unit at University College London, London, United Kingdom.; Department of Infection at Guy's and St. Thomas' Hospital and King's College London, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Vock+DM%22">Vock DM</searchLink>; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.<br /><searchLink fieldCode="AU" term="%22Gelijns+AC%22">Gelijns AC</searchLink>; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Weintrob+AC%22">Weintrob AC</searchLink>; Washington, DC Veteran Affairs Medical Center, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Bajema+KL%22">Bajema KL</searchLink>; Veterans Affairs Portland Health Care System, Portland, Oregon, USA.; Division of Infectious Diseases, Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.<br /><searchLink fieldCode="AU" term="%22Pett+SL%22">Pett SL</searchLink>; MRC Clinical Trials Unit at University College London, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Lundgren+J%22">Lundgren J</searchLink>; Department of Infectious Diseases, Centre of Excellence in Health Immunity and Infection, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Schechner+AJ%22">Schechner AJ</searchLink>; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Higgs+ES%22">Higgs ES</searchLink>; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Lane+HC%22">Lane HC</searchLink>; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Matthews+GV%22">Matthews GV</searchLink>; Kirby Institute, University of New South Wales, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Self+WH%22">Self WH</searchLink>; Vanderbilt Institute for Clinical and Translational Research Nashville, Vanderbilt University Medical Center, Tennessee, USA.; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.<br /><searchLink fieldCode="AU" term="%22Reilly+C%22">Reilly C</searchLink>; Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%229203213%22">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</searchLink> [Clin Infect Dis] 2026 Apr 22. <i>Date of Electronic Publication: </i>2026 Apr 22. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Oxford+University+Press%22">Oxford University Press </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>9203213 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1537-6591 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210584838%22">10584838 </searchLink><i>NLM ISO Abbreviation: </i>Clin Infect Dis <i>Subsets: </i>MEDLINE |
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