Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial

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dc.catalogadoryvc
dc.contributor.advisorLe Corre Perez, Monique Nicole
dc.contributor.authorBalcells Marty, Maria Elvira
dc.contributor.authorRojas Orellana, Luis Esteban
dc.contributor.authorMartínez Valdebenito, Constanza Pamela
dc.contributor.authorCeballos Valdivielso, María Elena Andrea
dc.contributor.authorFerrés Garrido, Marcela Viviana
dc.contributor.authorChang Rathkamp, Mayling Raquel
dc.contributor.authorVizcaya Altamirano, María Cecilia
dc.contributor.authorMondaca Contreras, Sebastián Patricio
dc.contributor.authorHuete Garín, Isidro Álvaro
dc.contributor.authorCastro López, Ricardo Adolfo
dc.contributor.authorSarmiento Maldonado, Mauricio
dc.contributor.authorVillarroel Del Pino, Luis Antonio
dc.contributor.authorPizarro Ibáñez, Alejandra Valentina
dc.contributor.authorRoss Pérez, Patricio Daniel
dc.contributor.authorSantander Toro, Jaime Andrés
dc.contributor.authorLara Hernández, Bárbara Alejandra
dc.contributor.authorFerrada Koch, Marcela Patricia
dc.contributor.authorVargas Salas, Sergio Sebastián
dc.contributor.authorBeltrán Pávez, Carolina
dc.contributor.authorSoto Rifo, Ricardo
dc.contributor.authorValiente Echeverria, Fernando Andrés
dc.contributor.authorCaglevic, Christian
dc.contributor.authorMahave, Mauricio
dc.contributor.authorSelman Bravo, Carolina Antoniett
dc.contributor.authorGazitúa, Raimundo
dc.contributor.authorBriones, José Luis
dc.contributor.authorVillarroel Espíndola, Franz
dc.contributor.authorBalmaceda Araque, Carlos Felipe
dc.contributor.authorEspinoza Sepúlveda, Manuel Antonio
dc.contributor.authorPereira Garces, Jaime
dc.contributor.authorNervi Nattero, Bruno
dc.date.accessioned2023-11-10T16:42:24Z
dc.date.available2023-11-10T16:42:24Z
dc.date.issued2021
dc.description.abstractBackground: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression.", "Methods and findings", "The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32-2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19-2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion.", "Conclusions", "In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration.
dc.fuente.origenConveris
dc.identifier.converisid1
dc.identifier.doi10.1371/journal.pmed.1003415
dc.identifier.eissn1549-1676
dc.identifier.issn1549-1277
dc.identifier.pubmedidMEDLINE_ID: 33657114
dc.identifier.scopusidSCOPUS_ID: 000624928100001
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/75280
dc.identifier.wosidWOS:000624928100001
dc.information.autorucFacultad de Ciencias Biológicas; Le Corre Perez, Monique Nicole; 0000-0002-9361-4049; 6737
dc.information.autorucEscuela de Medicina; Balcells Marty, Maria Elvira; 0000-0002-7223-9665; 7462
dc.information.autorucEscuela de Medicina; Rojas Orellana, Luis Esteban; 0000-0002-0234-5876; 135613
dc.information.autorucEscuela de Medicina; Martínez Valdebenito, Constanza Pamela; S/I; 1007539
dc.information.autorucEscuela de Medicina; Ceballos Valdivielso, María Elena Andrea; 0000-0002-5569-6485; 190187
dc.information.autorucEscuela de Medicina; Ferrés Garrido, Marcela Viviana; 0000-0001-9415-4657; 66180
dc.information.autorucEscuela de Medicina; Chang Rathkamp, Mayling Raquel; S/I; 65602
dc.information.autorucEscuela de Medicina; Vizcaya Altamirano, María Cecilia; 0000-0003-1309-9778; 7645
dc.information.autorucEscuela de Medicina; Mondaca Contreras, Sebastián Patricio; 0000-0002-1130-0370; 190152
dc.information.autorucEscuela de Medicina; Huete Garín, Isidro Álvaro; 0000-0002-8746-1111; 731
dc.information.autorucEscuela de Medicina; Castro López, Ricardo Adolfo; 0000-0002-0978-9891; 4537
dc.information.autorucEscuela de Medicina; Sarmiento Maldonado, Mauricio; 0000-0003-3715-9886; 167160
dc.information.autorucEscuela de Medicina; Villarroel Del Pino, Luis Antonio; 0000-0001-9603-937X; 77182
dc.information.autorucEscuela de Medicina; Pizarro Ibáñez, Alejandra Valentina; S/I; 1015453
dc.information.autorucEscuela de Medicina; Ross Pérez, Patricio Daniel; S/I; 1095610
dc.information.autorucEscuela de Medicina; Santander Toro, Jaime Andrés; 0000-0002-2156-8290; 83165
dc.information.autorucEscuela de Medicina; Lara Hernández, Bárbara Alejandra; 0000-0002-0265-808X; 149938
dc.information.autorucEscuela de Medicina; Ferrada Koch, Marcela Patricia; S/I; 89500
dc.information.autorucEscuela de Medicina; Vargas Salas, Sergio Sebastián; S/I; 187225
dc.information.autorucEscuela de Medicina; Selman Bravo, Carolina Antoniett; S/I; 159754
dc.information.autorucEscuela de Medicina; Balmaceda Araque, Carlos Felipe; 0000-0002-8381-2439; 169851
dc.information.autorucEscuela de Medicina; Espinoza Sepúlveda, Manuel Antonio; 0000-0001-9564-9512; 10720
dc.information.autorucEscuela de Medicina; Pereira Garces, Jaime; S/I; 35222
dc.information.autorucEscuela de Medicina; Nervi Nattero, Bruno; 0000-0002-3016-7261; 604
dc.issue.numero3
dc.language.isoen
dc.nota.accesoContenido completo
dc.revistaPLOS MEDICINE
dc.rightsacceso abierto
dc.rights.licenseAttribution 4.0 International (CC BY 4.0)
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleEarly versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial
dc.typeartículo
dc.volumen18
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