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Accès ouvert déclaré 2022 article

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19

31Citations signalées — pas une note de qualité
141Institutions déclarées
17Pays d’affiliation déclarés

Résumé fourni par la source

BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone. DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978). SETTING: Multinational, multicenter trial. PARTICIPANTS: Adults hospitalized with COVID-19. INTERVENTION: Intravenous ensovibep, 600 mg, or placebo. MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90. RESULTS: = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR < 1 would favor ensovibep). LIMITATION: The trial was prematurely stopped because of futility, limiting power for the primary outcome. CONCLUSION: Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified. PRIMARY FUNDING SOURCE: National Institutes of Health.

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Contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref
Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19
Date Crossref
01/09/2022
Éditeur
American College of Physicians
Type
journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude et ne compte pas comme une seconde source scientifique indépendante.

Institutions déclarées

Brown UniversityRhode Island HospitalMiriam HospitalNational and Kapodistrian University of AthensSotiria General HospitalNational Centre for Infectious DiseasesUniversity of MinnesotaDuke University HospitalTan Tock Seng HospitalIntermountain Medical CenterParkland Health & Hospital SystemThe University of Texas Southwestern Medical CenterVelocity Clinical Research (United States)Cedars-Sinai Medical CenterLira HospitalLung InstituteMakerere UniversityUniversity of California, San FranciscoCalifornia State University, FresnoThe Royal Free HospitalUniversity College LondonBaylor Scott & White HealthInstitute of Human VirologyMichael E. DeBakey VA Medical CenterBaylor College of MedicineLincoln Medical CenterUganda Virus Research InstituteMasaka HospitalUniversity of California San Francisco Medical CenterHoag Memorial Hospital PresbyterianUniversity of San FranciscoUniversity of Colorado HospitalUniversity of Colorado DenverUniversity of ZurichUniversity Hospital ZurichCHRISTUS Spohn Hospital Corpus Christi - MemorialGulu HospitalUniversity of South FloridaTampa General HospitalThe Lundquist InstituteRigshospitaletCentre of Excellence for Health, Immunity and InfectionsZealand University HospitalIcahn School of Medicine at Mount SinaiNational Institute of Allergy and Infectious DiseasesFrederick National Laboratory for Cancer ResearchLeidos (United States)Leidos Biomedical Research Inc. (United States)National Institutes of HealthNational Institutes of Health Clinical CenterMedical Research CouncilUniversity of UtahVanderbilt University Medical CenterHarvard UniversityMassachusetts General HospitalUNSW SydneySalem VA Medical CenterUnited States Department of Veterans AffairsVeterans Medical Research Foundation of San DiegoVA Northern California Health Care SystemVeterans Health AdministrationHospital Universitari Germans Trias i PujolMedical University of WarsawWojewódzki Szpital ZespolonyMolecular Partners (Switzerland)Novartis (United States)National Heart, Lung, and Blood InstituteFoundation for the National Institutes of HealthCleveland ClinicDuke University Health SystemLutheran Medical GroupOchsner Medical CenterUniversity of Virginia Health SystemMinneapolis Heart Institute FoundationJohns Hopkins UniversityBaystate Medical CenterBrigham and Women's HospitalHadassah Medical CenterUniversity of MississippiRonald Reagan UCLA Medical CenterOregon Health & Science UniversityStanford UniversityUniversity of California, DavisUniversity of MichiganMontefiore Medical CenterBanner - University Medical Center TucsonUniversity of CincinnatiThe Ohio State UniversityUniversity of Washington Medical CenterSwedish Family Medicine Residency - Cherry HillAtrium Health Wake Forest BaptistFoundation for Biomedical ResearchHendrick Medical CenterCarilion Roanoke Memorial HospitalCotton (United States)MedStar HealthHennepin Healthcare Research InstituteMinneapolis VA Medical CenterSUNY Downstate Health Sciences UniversityUniversity of Minnesota SystemVA San Diego Healthcare SystemVA Tennessee Valley Healthcare SystemSacramento VA Medical CenterPortland VA Medical CenterVA Portland Health Care SystemCharles George VA Medical CenterSouthern Arizona VA Health Care SystemSan Francisco VA Health Care SystemBay Pines VA Healthcare SystemVA Long Beach Healthcare SystemUniversity of CopenhagenCopenhagen University HospitalGentofte HospitalAarhus UniversityAarhus University HospitalOdense University HospitalKolding HospitalAalborg University HospitalBispebjerg HospitalZealand University Hospital KøgeHospital General Universitario Gregorio MarañónBarcelona Institute for Global HealthUniversitat de BarcelonaHospital Universitario La PazHospital Clínico San CarlosVall d'Hebron Hospital UniversitariHospital Universitari Arnau de VilanovaAIDS and Clinical Immunology Research CenterIvano-Frankivsk National Medical UniversityEstudios Clínicos LatinoaméricaHospital Ramos MejíaHospital Italiano de Buenos AiresCentro de Educación Médica e Investigaciones Clínicas Norberto QuirnoMRC Clinical Trials Unit at UCLRoyal Victoria InfirmaryEvangelismos HospitalDemocritus University of ThraceNsambya HospitalManhiça Health Research CentreGilead Sciences (United States)Novartis (Ireland)

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Sujets associés

COVID-19 Clinical Research StudiesLong-Term Effects of COVID-19Pharmacological Receptor Mechanisms and Effects

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