Interferon β-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial

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dc.article.number102082
dc.catalogadorvzp
dc.contributor.authorCastro Rodríguez, José Antonio
dc.contributor.authorFish, Eleanor
dc.contributor.authorMontgomery, Samuel T.
dc.contributor.authorKollmann, Tobias R.
dc.contributor.authorIturriaga Ortiz, Carolina Alejandra
dc.contributor.authorShannon, Casey
dc.contributor.authorKarpievitch, Yuliya
dc.contributor.authorHo, Joseph
dc.contributor.authorChen, Virginia
dc.contributor.authorBalshaw, Robert
dc.contributor.authorBen-Othman, Rym
dc.contributor.authorAniba, Radhouane
dc.contributor.authorGidi Yunge, Francisca Andrea
dc.contributor.authorHartnell, Lucy
dc.contributor.authorHancock, David G.
dc.contributor.authorPerez Mateluna, Guillermo Andrés
dc.contributor.authorUrzua, Marcela
dc.contributor.authorTebbutt, Scott J.
dc.contributor.authorGarcia-Huidobro, Munita Diego Nicolas
dc.contributor.authorPerret, Perez Cecilia
dc.contributor.authorBorzutzky Schachter, Arturo José
dc.contributor.authorStick, Stephen M.
dc.date.accessioned2024-06-07T15:14:04Z
dc.date.available2024-06-07T15:14:04Z
dc.date.issued2023
dc.description.abstract© 2023 The Author(s)Background: Accumulating evidence indicates that an early, robust type 1 interferon (IFN) response to SARS-CoV-2 is important in determining COVID-19 outcomes, with an inadequate IFN response associated with disease severity. Our objective was to examine the prophylactic potential of IFN administration to limit viral transmission. Methods: A cluster randomised open label clinical trial was undertaken to determine the effects of pegylated IFNβ-1a administration on SARS-CoV-2 household transmission between December 3rd, 2020 and June 29th, 2021. Index cases were identified from databases of confirmed SARS-CoV-2 individuals in Santiago, Chile. Households were cluster randomised (stratified by household size and age of index cases) to receive 3 doses of 125 μg subcutaneous pegylated IFNβ-1a (172 households, 607 participants), or standard care (169 households, 565 participants). The statistical team was blinded to treatment assignment until the analysis plan was finalised. Analyses were undertaken to determine effects of treatment on viral shedding and viral transmission. Safety analyses included incidence and severity of adverse events in all treatment eligible participants in the standard care arm, or in the treatment arm with at least one dose administered. Clinicaltrials.gov identifier: NCT04552379. Findings: 5154 index cases were assessed for eligibility, 1372 index cases invited to participate, and 341 index cases and their household contacts (n = 831) enrolled. 1172 participants in 341 households underwent randomisation, with 607 assigned to receive IFNβ-1a and 565 to standard care. Based on intention to treat (ITT) and per protocol (PP) analyses for the primary endpoints, IFNβ-1a treatment did not affect duration of viral shedding in index cases (absolute risk reduction = −0.2%, 95% CI = −8.46% to 8.06%) and transmission of SARS-CoV-2 to household contacts (absolute risk reduction = 3.87%, 95% CI = −3.6% to 11.3%). Treatment with IFNβ-1a resulted in significantly more treatment-related adverse events, but no increase in overall adverse events or serious adverse events. Interpretation: Based upon the primary analyses, IFNβ-1a treatment did not affect duration of viral shedding or the probability of SARS-CoV-2 transmission to uninfected contacts within a household. Funding: Biogen PTY Ltd. Supply of interferon as ‘Plegridy (peginterferon beta-1a).’ The study was substantially funded by BHP Holdings Pty Ltd.
dc.fechaingreso.objetodigital2024-06-07
dc.format.extent13 páginas
dc.fuente.origenScopus
dc.identifier.doi10.1016/j.eclinm.2023.102082
dc.identifier.issn25895370
dc.identifier.scopusidSCOPUS_ID:85165962095
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/86627
dc.information.autorucEscuela de Medicina; Castro Rodríguez, José Antonio; 0000-0002-0708-4281; 113247
dc.information.autorucEscuela de Medicina; Iturriaga Ortiz, Carolina Alejandra; S/I; 1058623
dc.information.autorucEscuela de Odontología; Gidi Yunge, Francisca Andrea; S/I; 234552
dc.information.autorucEscuela de Medicina; Perez Mateluna, Guillermo Andrés; S/I; 1078205
dc.information.autorucEscuela de Medicina; Garcia-Huidobro, Munita Diego Nicolas; 0000-0003-1964-7640; 16671
dc.information.autorucEscuela de Medicina; Perret Perez, Cecilia; 0000-0002-1535-1204; 80387
dc.information.autorucEscuela de Medicina; Borzutzky Schachter, Arturo José; 0000-0002-7904-262X; 5897
dc.language.isoen
dc.nota.accesocontenido completo
dc.publisherElsevier Ltd
dc.revistaeClinicalMedicine
dc.rightsacceso abierto
dc.rights.licenseAttribution-NonCommercial-NoDerivs 4.0 International (CC BY-NC-ND 4.0)
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectCOVID-19
dc.subjectInterferon
dc.subjectRing prophylaxis
dc.subjectSARS-CoV-2
dc.subjectTransmission
dc.subject.ddc610
dc.subject.deweyMedicina y salud
dc.titleInterferon β-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial
dc.typeartículo
dc.volumen62
sipa.codpersvinculados113247
sipa.codpersvinculados1058623
sipa.codpersvinculados234552
sipa.codpersvinculados1078205
sipa.codpersvinculados16671
sipa.codpersvinculados80387
sipa.codpersvinculados5897
sipa.trazabilidadSCOPUS;2023-08-23
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