2025
Uric Acid Stroke Cerebroprotection Transcended Sex, Age, and Comorbidities in a Multicenter Preclinical Trial
Patel R, Kumskova M, Kodali H, Budnik I, Kuznetsov V, Jain A, Jha A, Thedens D, Dhanesha N, Sutariya B, Nagarkatti K, Lamb J, Kamat P, Shi Y, Avery B, Imai T, Jin X, Chauhan A, Boisserand L, Khan M, Dhandapani K, Sanganahalli B, Sansing L, Hess D, Koehler R, McCullough L, Aronowski J, Ayata C, Diniz M, Lyden P, Planas A, Chamorro A, Chauhan A, Leira E, Investigators O. Uric Acid Stroke Cerebroprotection Transcended Sex, Age, and Comorbidities in a Multicenter Preclinical Trial. Stroke 2025, 56: 965-973. PMID: 40091742, PMCID: PMC11932773, DOI: 10.1161/strokeaha.124.048748.Peer-Reviewed Original ResearchConceptsUA-treated animalsPrimary functional outcomeFunctional outcomesMiddle cerebral artery filament occlusionModified intention-to-treat populationIntention-to-treat populationUric acidHuman clinical trialsImprove functional outcomesStudy drugIntravenous salineEffects of UARelevant to patientsClinical trialsPrimary outcomeSaline controlsSecondary outcomesPreclinical trialsDay 2Survival rateDay 7Filament occlusionGroups of animalsComorbiditiesDiverse comorbidities
2024
Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study
Aranow C, Allaart C, Amoura Z, Bruce I, Cagnoli P, Chatham W, Clark K, Furie R, Groark J, Urowitz M, van Vollenhoven R, Daniels M, Fox N, Gregan Y, Henderson R, van Maurik A, Ocran-Appiah J, Oldham M, Roth D, Shanahan D, Tak P, Teng Y. Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study. Annals Of The Rheumatic Diseases 2024, 83: 1502-1512. PMID: 39159997, PMCID: PMC11503042, DOI: 10.1136/ard-2024-225686.Peer-Reviewed Original ResearchSystemic lupus erythematosusProportion of patientsCycles of rituximabSubcutaneous belimumabLupus erythematosusSafety of sequential therapyModified intention-to-treat populationIntention-to-treat populationDisease control durationDisease controlInvestigation of combination treatmentsDisease activity markersAnti-dsDNA antibodiesDisease activity controlIntravenous placeboImmunosuppression withdrawalIntravenous rituximabSequential therapyClinical remissionStandard therapySecondary endpointsActivation markersAnti-dsDNARituximabPhase 3Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial
Allen J, Lin J, Basta I, Dysgaard T, Eggers C, Guptill J, Gwathmey K, Hewamadduma C, Hofman E, Hussain Y, Kuwabara S, Le Masson G, Leypoldt F, Chang T, Lipowska M, Lowe M, Lauria G, Querol L, Simu M, Suresh N, Tse A, Ulrichts P, Van Hoorick B, Yamasaki R, Lewis R, van Doorn P, Grinzinger S, Wanschitz J, Seifert-Held T, Claeys K, Baets J, Remiche G, Bissay V, Dubuisson N, Delstanche S, Tarnev I, Genov K, Tsvetanov P, Milanov I, Zhao C, Bu B, Yu X, Li W, Jiang H, Da Y, Lu Z, Liang H, Guo F, Li Z, Zou Z, Hong D, Yang H, Guo J, Shi J, Tu J, He D, Wang Y, Ding J, Zhang Y, Zhao Y, Xu R, Yue Y, Guo A, Wang Y, Talab R, Harbo T, Sindrup S, De Seze J, Sacconi S, Péréon Y, Echaniz-Laguna A, Magy L, Nicolas G, Taithe F, Cassereau J, Debs R, Shakarishvili R, Tsiskaridze A, Mania M, Janelidze M, Janelidze T, Schroeter M, Skripuletz T, Lee D, Klehmet J, Hotter B, Hoffmann O, Baum P, Zschuentzsch J, Pitarokoili K, Stettner M, Bereczki D, Pánczél G, Abraham A, Dori A, Lampl Y, Manganelli F, Morino S, Padovani A, Siciliano G, Schenone A, Magri F, Mazzeo A, Giannini F, Sorbi S, Chiò A, Kuwahara M, Okuno T, Okamoto T, Kokubun N, Nishiyama K, Kaida K, Bokuda K, Katsuno M, Yabe I, Saji E, Yokota T, Hatanaka Y, Nakahara J, Sugimoto T, Tanaka F, Tomita S, Yamano Y, Hayashi T, Yamazaki H, Tokashiki T, Horiuchi K, Karelis G, Eftimov F, Banach M, Chyrchel-Paszkiewicz U, Kochanowicz J, Selmaj K, Zielinski T, Banaszkiewicz K, Mitrea D, Scutaru-Kadar A, Axelerad A, Stuchevskaya F, Boyko A, Khabirov F, Trushnikova T, Goncharova Z, Suponeva N, Dorogov N, Yakupov E, Raicevic R, Miletic Drakulic S, Cabrera Serrano M, Muñoz Blanco J, Guerrero Sola A, Aguera Morales E, Diaz Marin C, Juntas Morales R, Yeh J, Sung J, Huang H, Tsai N, Guo Y, Chao C, Ro L, Sengun I, Terzi M, Alpaydin Baslo S, Koç F, Necdet Karli H, Shulga O, Smolko D, Doroshenko O, Tomakh N, Kyrychenko A, Seliuk O, Kalbus O, Skrypchenko I, Novakovska O, Carod-Artal F, Rinaldi S, Brennan K, Ellis S, Carr A, Matthews E, Traub R, Mozaffar T, Elliott M, Bhavaraju-Sanka R, Nance C, Levine T, Lisak R, Pasnoor M, Pulley M, Roy B, Govindarajan R, Sahagian G, Khella S, Jacob D, Kushlaf H, Sivakumar K, Melamed I, Sharma K, Quick A, Ubogu E, Lacomis D, Isa A, Brannagan T, Chen S, Katz J, Feinberg M, Pavlakis P, Lange D, Gudesblatt M, Tandan R, Gable K, Rivner M, Barnes B, Luke D, Mahuwala Z, Macwan S, Kwon P, Scott J, Altamimi S, Sabharwal P. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial. The Lancet Neurology 2024, 23: 1013-1024. PMID: 39304241, DOI: 10.1016/s1474-4422(24)00309-0.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsChronic inflammatory demyelinating polyradiculoneuropathyRisk of relapseInflammatory demyelinating polyradiculoneuropathyStage BStage ADouble-blindModified intention-to-treat populationIntention-to-treat populationOpen-label phaseInflammatory Neuropathy CauseInteractive response technologyPhase 2 trialPlacebo-controlled trialEvidence of clinical improvementClinically meaningful deteriorationPeripheral nervous systemPartial responseSafety populationPlacebo groupPlacebo-controlledResidual neurological impairmentClinical improvementWeeks treatmentTreatment optionsSafety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials
Diawara H, Healy S, Mwakingwe-Omari A, Issiaka D, Diallo A, Traore S, Soumbounou I, Gaoussou S, Zaidi I, Mahamar A, Attaher O, Fried M, Wylie B, Mohan R, Doan V, Doritchamou J, Dolo A, Morrison R, Wang J, Hu Z, Rausch K, Zeguime A, Murshedkar T, Natasha K, Sim B, Billingsley P, Richie T, Hoffman S, Dicko A, Duffy P, Team P, Traore M, Samassekou M, Dicko O, N'Diaye O, Sidibe Y, Niambele S, Diarra K, Cisse K, Diarra I, Niangaly A, Diarra B, Bengaly K, Doucoure M, Dembele A, Samake I, Diarra B, Lane J, Gorres J, Marte-Salcedo O, Tran D, Neal J, Bah A, Gupta M, Abebe Y, James E, Manoj A. Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. The Lancet Infectious Diseases 2024, 24: 1366-1382. PMID: 39153490, DOI: 10.1016/s1473-3099(24)00360-8.Peer-Reviewed Original ResearchPfSPZ VaccineArtemether-lumefantrineClinical malariaAdverse eventsVaccine efficacyVaccine doseWeeks 0Before doseNeonatal outcomesAntimalarial treatmentDouble-blindMalaria seasonSaline placeboSaline groupVaccine groupFollow-upBooster doseModified intention-to-treat populationBlock randomisationHuman chorionic gonadotropin testIntention-to-treat populationTransmission seasonFrequency of adverse eventsPlasmodium falciparum parasitaemiaMalaria transmission seasonPhase 1b/2 study of orally administered pexidartinib in combination with radiation therapy and temozolomide in patients with newly diagnosed glioblastoma
Mendez J, Cohen A, Eckenstein M, Jensen R, Burt L, Salzman K, Chamberlain M, Hsu H, Hutchinson M, Iwamoto F, Ligon K, Mrugala M, Pelayo M, Plotkin S, Puduvalli V, Raizer J, Reardon D, Sterba M, Walbert T, West B, Wong E, Zhang C, Colman H. Phase 1b/2 study of orally administered pexidartinib in combination with radiation therapy and temozolomide in patients with newly diagnosed glioblastoma. Neuro-Oncology Advances 2024, 6: vdae202. PMID: 39734810, PMCID: PMC11672110, DOI: 10.1093/noajnl/vdae202.Peer-Reviewed Original ResearchMedian overall survivalRadiation therapyAdjuvant TMZTumor microenvironmentRecommended phase 2 doseModified intention-to-treat populationIntention-to-treat populationPhase 1b/2 studyPhase 1b/2 trialPhase 2 doseProgression-free survivalNewly diagnosed glioblastomaInhibitor of CSF1RMultiple dose levelsPhase 2 patientsDose escalationMedian survivalDiagnosed GBMOverall survivalOpen-labelStudy regimensTreatment resistanceGlioma modelRP2DHistorical controls
2023
Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial
Brown S, Barkauskas C, Grund B, Sharma S, Phillips A, Leither L, Peltan I, Lanspa M, Gilstrap D, Mourad A, Lane K, Beitler J, Serra A, Garcia I, Almasri E, Fayed M, Hubel K, Harris E, Middleton E, Barrios M, Mathews K, Goel N, Acquah S, Mosier J, Hypes C, Campbell E, Khan A, Hough C, Wilson J, Levitt J, Duggal A, Dugar S, Goodwin A, Terry C, Chen P, Torbati S, Iyer N, Sandkovsky U, Johnson N, Robinson B, Matthay M, Aggarwal N, Douglas I, Casey J, Hache-Marliere M, Youssef J, Nkemdirim W, Leshnower B, Awan O, Pannu S, O'Mahony D, Manian P, Hayanga J, Wortmann G, Tomazini B, Miller R, Jensen J, Murray D, Bickell N, Zatakia J, Burris S, Higgs E, Natarajan V, Dewar R, Schechner A, Kang N, Arenas-Pinto A, Hudson F, Ginde A, Self W, Rogers A, Oldmixon C, Morin H, Sanchez A, Weintrob A, Cavalcanti A, Davis-Karim A, Engen N, Denning E, Thompson B, Gelijns A, Kan V, Davey V, Lundgren J, Babiker A, Neaton J, Lane H, Group A, Tierney J, Vogel S, McNay L, Cahill K, Crew P, Sardana R, Raim S, Shaw-Saliba K, Atri N, Miller M, Vallee D, Chung L, Delph Y, Adam S, Read S, Draghia-Akli R, Harrigan R, Carlsen A, Carter A, DuChene A, Eckroth K, Frase A, Harrison M, Meger S, Quan K, Quan S, Reilly C, Thompson G, Walski J, Moskowitz A, Bagiella E, Moquete E, O'Sullivan K, Marks M, Accardi E, Kinzel E, Bedoya G, Gupta L, Overbey J, Padillia M, Santos M, Gillinov M, Miller M, Taddei-Peters W, Fenton K, Smith P, Vekstein A, Ko E, Al-Hegelan M, McGowan L, Motta M, Howell S, Bent F, Kalager R, Chan E, Aloor H, Griffin S, Covington A, McLendon-Arvik B, Bussadori B, Miller-Bell M, Sampey C, Gaver V, Hollister B, Giangiacomo D, Pauley A, Patel A, Classon C, Frazier M, Osborne R, Conlon D, Joshi M, Gottlieb R, Mack M, Berhe M, Haley C, Dishner E, Bettacchi C, Golden K, Duhaime E, Ryan M, Tallmadge C, Estrada L, Jones F, Villa S, Wang S, Robert R, Coleman T, Clariday L, Baker R, Hurutado-Rodriguez M, Iram N, Fresnedo M, Davis A, Leonard K, Ramierez N, Thammavong J, Duque K, Turner E, Fisher T, Robinson D, Ransom D, Maldonado N, Lusk E, Killian A, Palacios A, Solis E, Jerrow J, Watts M, Whitacre H, Cothran E, Bender W, Miller J, Nugent K, Farrington W, Baio K, McBride M, Fielding M, Mathewson S, Porte K, Haley E, Rogers S, Tyler D, Perin E, Costello B, Postalian A, Sohail R, Hinsu P, Watson C, Kappenman C, Chen J, Walker K, Fink M, Phillip G, Mahon K, Sturgis L, Maher P, Rogers L, Ng N, Marshall J, Bassily-Marcus A, Cohen I, Ramoo S, Malhotra A, Kessler J, Goetz R, Badhwar V, Hayanga J, Sutton L, Williams R, Bartolo E, Walker D, Bunner R, Glaze C, Aucremanne T, Bishop J, Kelley M, Peterson A, Sauerborn E, Reckart R, Miller B, Mittel A, Darmanian A, Rosen A, Madahar P, Schicchi J, Gosek K, Dzierba A, Wahab R, Eng C, Al-Saadi M, Zahiruddin F, Syed M, George M, Patel V, Onwunyi C, da Costa R, North C, Ringwood N, Fitzgerald L, Muzikansky A, Morse R, Brower R, Reineck L, Bienstock K, Hou P, Steingrub J, Tidswell M, Kozikowski L, Kardos C, De Souza L, Talmor D, Shapiro N, Hibbert K, Brait K, Kone M, Hendey G, Kangelaris K, Ashktorab K, Gropper R, Agrawal A, Timothy K, Zhou H, Hughes A, Garcia R, Torres A, Hernandez-Almaraz M, Vojnik R, Perez C, McDowell J, Chang S, Vargas J, Moss M, McKeehan J, Higgins C, Johnson E, Slaughter S, Wyles D, Hiller T, Oakes J, Garcia A, Gravitz S, Lyle C, Swanson D, Gong M, Richardson L, Chen J, Moskowitz A, Mohamed A, Lopez B, Amosu O, Tzehaie H, Boujid S, Bixby B, Lopez A, Durley J, Gilson B, Hite R, Wang H, Wiedemann H, Mehkri O, Ashok K, King A, Brennan C, Exline M, Englert J, Karow S, Schwartz E, So P, So M, Krol O, Parra G, Mills E, Oh M, Pena J, Martínez J, Jackman S, Bayoumi E, Pascual E, Caudill A, Chen P, Richardson T, Clapham G, Herrera L, Ojukwu C, Fine D, Gomez M, Choi-Kuaea Y, Weissberg G, Isip K, Mattison B, Tran D, Dukov J, Chung P, Kang B, Escobar L, Tran T, Baig S, Wallick J, Duven A, Fletcher D, Gundel S, Fuentes M, Newton M, Peterson E, Jiang K, Files D, Miller C, Lematty C, Rasberry A, Warden A, Bledsoe J, Knowlton K, Knox D, Klippel C, Armbruster B, Applegate D, Imel K, Fergus M, Rahmati K, Jensen H, Aston V, Jeppson J, Marshall J, Lumpkin J, Smith C, Burke T, Gray A, Paine R, Callahan S, Yamane M, Waddoups L, Rice T, Johnson J, Gray C, Hays M, Roth M, Musick S, Miller K, Semler M, Popielski L, Kambo A, Viens K, Turner M, Vjecha M, Denyer R, Khosla R, Rajendran B, Gonzales M, Moriarty T, Biswas K, Harrington C, Garcia A, Bremer T, Burke T, Koker B, Pittman D, Vasudeva S, Anholm J, Specht L, Rodriguez A, Ngo H, Duong L, Previte M, Raben D, Nielsen C, Larsen J, Peters L, Matthews G, Kelleher A, Polizzotto M, Carey C, Chang C, Dharan N, Hough S, Virachit S, Davidson S, Bice D, Ognenovska K, Cabrera G, Flynn R, Abdelghany M, Baseler B, Teitelbaum M, Holley H, Jankelevich S, Adams A, Becker N, Doleny S, Hissey D, Simpson S, Kim M, Beeler J, Harmon L, Vanderpuye S, Yeon L, Frye L, Rudzinski E, Buehn M, Eccard-Koons V, Frary S, MacDonalad L, Cash J, Hoopengardner L, Linton J, Nelson M, Spinelli-Nadzam M, Proffitt C, Lee C, Engel T, Fontaine L, Osborne C, Hohn M, Galcik M, Thompson D, Sandrus J, Manchard J, Giri J, Kopka S, Chang W, Sherman B, Rupert A, Highbarger H, Baseler M, Lallemand P, Rehman T, Imamichi T, Laverdure S, Paudel S, Cook K, Haupt K, Hazen A, Badralmaa Y, Highbarger J, McCormack A, Gerry N, Smith K, Patel B, Domeraski N, Hoover M, DuChateau N, Flosi A, Nelson R, Stojanovic J, Wenner C. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial. The Lancet Respiratory Medicine 2023, 11: 791-803. PMID: 37348524, PMCID: PMC10527239, DOI: 10.1016/s2213-2600(23)00147-9.Peer-Reviewed Original ResearchConceptsAcute hypoxaemic respiratory failureHypoxaemic respiratory failureMatching placeboRespiratory failurePlacebo groupAdverse eventsOff oxygenModified intention-to-treat populationOdds ratioAcute hypoxemic respiratory failureIntention-to-treat populationModified intention-to-treat analysisHigh-flow nasal oxygenInfusion days 1Daily maintenance doseHypoxemic respiratory failurePlacebo-controlled trialDisease severityPrimary efficacy endpointInvasive mechanical ventilationBaseline disease severityIntention-to-treat analysisIntensive care unitSARS-CoV-2 infectionHospitalised adult patientsSafety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study
Howard J, Bresch S, Genge A, Hewamadduma C, Hinton J, Hussain Y, Juntas-Morales R, Kaminski H, Maniaol A, Mantegazza R, Masuda M, Sivakumar K, Śmiłowski M, Utsugisawa K, Vu T, Weiss M, Zajda M, Boroojerdi B, Brock M, de la Borderie G, Duda P, Lowcock R, Vanderkelen M, Leite M, Team R, Sembinelli D, Teitelbaum J, Nicolle M, Bernard E, Svahn J, Spinazzi M, Stojkovic T, Demeret S, Weiss N, Le Guennec L, Messai S, Tranchant C, Nadaj-Pakleza A, Chanson J, Suliman M, Zaidi L, Tard C, Lecointe P, Zschüntzsch J, Schmidt J, Glaubitz S, Zeng R, Scholl M, Kowarik M, Ziemann U, Krumbholz M, Martin P, Ruschil C, Dünschede J, Kemmner R, Rumpel N, Berger B, Totzeck A, Hagenacker T, Stolte B, Iorio R, Evoli A, Falso S, Antozzi C, Frangiamore R, Vanoli F, Rinaldi E, Deguchi K, Minami N, Nagane Y, Suzuki Y, Ishida S, Suzuki S, Nakahara J, Nagaoka A, Yoshimura S, Konno S, Tsuya Y, Uzawa A, Kubota T, Takahashi M, Okuno T, Murai H, Gilhus N, Boldingh M, Rønning T, Chyrchel-Paszkiewicz U, Kumor K, Zielinski T, Banaszkiewicz K, Błaż M, Kłósek A, Świderek-Matysiak M, Szczudlik A, Paśko A, Szczechowski L, Banach M, Ilkowski J, Garcia S, Bagan P, Segura A, Sans J, Fernandez N, Vicente E, Armenteros P, Ashraghi M, Cavey A, Haslam L, Emery A, Liow K, Yegiaian S, Barboi A, Vazquez R, Lennon J, Pascuzzi R, Bodkin C, Guingrich S, Comer A, Bromberg M, Janecki T, Saba S, Tellez M, Elsheikh B, Freimer M, Heintzman S, Govindarajan R, Guptill J, Massey J, Juel V, Gonzalez N, Habib A, Mozaffar T, Korb M, Goyal N, Machemehl H, Manousakis G, Allen J, Harper E, Farmakidis C, Saavedra L, Dimachkie M, Pasnoor M, Akhter S, Beydoun S, McIlduff C, Nye J, Roy B, Sheldon B, Nowak R, Barnes B, Rivner M, Suresh N, Shaw J, Harvey B, Lam L, Thomas N, Chopra M, Traub R, Jones S, Wagoner M, Smajic S, Aly R, Katz J, Chen H, Miller R, Jenkins L, Khan S, Khatri B, Sershon L, Pavlakis P, Holzberg S, Li Y, Caristo I, Marquardt R, Hastings D, Rube J, Lisak R, Choudhury A, Ruzhansky K, Sachdev A, Shin S, Bratton J, Fetter M, McKinnon N, McKinnon J, Sissons-Ross L, Sahu A, Distad B. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. The Lancet Neurology 2023, 22: 395-406. PMID: 37059508, DOI: 10.1016/s1474-4422(23)00080-7.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsGeneralised myasthenia gravisOpen-label extension studyMG-ADL scoresBaseline to weekMyasthenia gravisDouble-blindPlacebo-controlledIncidence of treatment-emergent adverse eventsMG-ADLModified intention-to-treat populationIntention-to-treat populationExtension studyQuantitative Myasthenia Gravis ScoreComplement C5 inhibitorInjection-site bruisingPhase 3 studyPhase 3 trialPopulation of patientsLong-term safetyPotential treatment optionMyasthenia Gravis ActivitiesClinically meaningful improvementsMyasthenia Gravis Activities of Daily LivingMatching placeboRandomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers
Pittet L, Messina N, Orsini F, Moore C, Abruzzo V, Barry S, Bonnici R, Bonten M, Campbell J, Croda J, Dalcolmo M, Gardiner K, Gell G, Germano S, Gomes-Silva A, Goodall C, Gwee A, Jamieson T, Jardim B, Kollman T, Lacerda M, Lee K, Lucas M, Lynn D, Manning L, Marshall H, McDonald E, Munns C, Nicholson S, O’Connell A, de Oliveira R, Perlen S, Perrett K, Prat-Aymerich C, Richmond P, Rodriguez-Baño J, dos Santos G, da Silva P, Teo J, Villanueva P, Warris A, Wood N, Davidson A, Curtis N. Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. New England Journal Of Medicine 2023, 388: 1582-1596. PMID: 37099341, PMCID: PMC10497190, DOI: 10.1056/nejmoa2212616.Peer-Reviewed Original ResearchConceptsBacille Calmette-GuerinModified intention-to-treat populationIntention-to-treat populationSevere COVID-19Placebo groupSymptomatic COVID-19Health care workersBCG-DenmarkPlacebo-controlled trialCare workersRisk of severe COVID-19Double-blindSaline placeboRisk of symptomatic COVID-19Severe acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Negative testRandomized trialsRespiratory syndrome coronavirus 2Hazard ratioPrimary outcomeBCG vaccinationTrial definitionSyndrome coronavirus 2Risk difference
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