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dc.contributor.authorWriting Committee for the REMAP-CAP Investigators
dc.contributor.authorEstcourt, Lise J
dc.contributor.authorTurgeon, Alexis F
dc.contributor.authorMcQuilten, Zoe K
dc.contributor.authorMcVerry, Bryan J
dc.contributor.authorAl-Beidh, Farah
dc.contributor.authorAnnane, Djillali
dc.contributor.authorArabi, Yaseen M
dc.contributor.authorArnold, Donald M
dc.contributor.authorBeane, Abigail
dc.contributor.authorBégin, Philippe
dc.contributor.authorvan Bentum-Puijk, Wilma
dc.contributor.authorBerry, Lindsay R
dc.contributor.authorBhimani, Zahra
dc.contributor.authorBirchall, Janet E
dc.contributor.authorBonten, Marc JM
dc.contributor.authorBradbury, Charlotte A
dc.contributor.authorBrunkhorst, Frank M
dc.contributor.authorBuxton, Meredith
dc.contributor.authorCallum, Jeannie L
dc.contributor.authorChassé, Michaël
dc.contributor.authorCheng, Allen C
dc.contributor.authorCove, Matthew E
dc.contributor.authorDaly, James
dc.contributor.authorDerde, Lennie
dc.contributor.authorDetry, Michelle A
dc.contributor.authorDe Jong, Menno
dc.contributor.authorEvans, Amy
dc.contributor.authorFergusson, Dean A
dc.contributor.authorFish, Matthew
dc.contributor.authorFitzgerald, Mark
dc.contributor.authorFoley, Claire
dc.contributor.authorGoossens, Herman
dc.contributor.authorGordon, Anthony C
dc.contributor.authorGosbell, Iain B
dc.contributor.authorGreen, Cameron
dc.contributor.authorHaniffa, Rashan
dc.contributor.authorHarvala, Heli
dc.contributor.authorHiggins, Alisa M
dc.contributor.authorHills, Thomas E
dc.contributor.authorHoad, Veronica C
dc.contributor.authorHorvat, Christopher
dc.contributor.authorHuang, David T
dc.contributor.authorHudson, Cara L
dc.contributor.authorIchihara, Nao
dc.contributor.authorLaing, Emma
dc.contributor.authorLamikanra, Abigail A
dc.contributor.authorLamontagne, François
dc.contributor.authorLawler, Patrick R
dc.contributor.authorLinstrum, Kelsey
dc.contributor.authorLitton, Edward
dc.contributor.authorLorenzi, Elizabeth
dc.contributor.authorMacLennan, Sheila
dc.contributor.authorMarshall, John
dc.contributor.authorMcAuley, Daniel F
dc.contributor.authorMcDyer, John F
dc.contributor.authorMcGlothlin, Anna
dc.contributor.authorMcGuinness, Shay
dc.contributor.authorMiflin, Gail
dc.contributor.authorMontgomery, Stephanie
dc.contributor.authorMouncey, Paul R
dc.contributor.authorMurthy, Srinivas
dc.contributor.authorNichol, Alistair
dc.contributor.authorParke, Rachael
dc.contributor.authorParker, Jane C
dc.contributor.authorPriddee, Nicole
dc.contributor.authorPurcell, Damian FJ
dc.contributor.authorReyes, Luis F
dc.contributor.authorRichardson, Peter
dc.contributor.authorRobitaille, Nancy
dc.contributor.authorRowan, Kathryn M
dc.contributor.authorRynne, Jennifer
dc.contributor.authorSaito, Hiroki
dc.contributor.authorSantos, Marlene
dc.contributor.authorSaunders, Christina T
dc.contributor.authorSerpa Neto, Ary
dc.contributor.authorSeymour, Christopher W
dc.contributor.authorSilversides, Jon A
dc.contributor.authorTinmouth, Alan A
dc.contributor.authorTriulzi, Darrell J
dc.contributor.authorTurner, Anne M
dc.contributor.authorvan de Veerdonk, Frank
dc.contributor.authorWalsh, Timothy S
dc.contributor.authorWood, Erica M
dc.contributor.authorBerry, Scott
dc.contributor.authorLewis, Roger J
dc.contributor.authorMenon, David
dc.contributor.authorMcArthur, Colin
dc.contributor.authorZarychanski, Ryan
dc.contributor.authorAngus, Derek C
dc.contributor.authorWebb, Steve A
dc.contributor.authorRoberts, David J
dc.contributor.authorShankar-Hari, Manu
dc.date.accessioned2022-02-10T00:30:06Z
dc.date.available2022-02-10T00:30:06Z
dc.date.issued2021-11-02
dc.identifier.issn0098-7484
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/333814
dc.description.abstractIMPORTANCE: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. OBJECTIVE: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONS: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURES: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS: Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group. CONCLUSIONS AND RELEVANCE: Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02735707.
dc.format.mediumPrint-Electronic
dc.publisherAmerican Medical Association (AMA)
dc.rightsAll Rights Reserved
dc.rights.urihttp://www.rioxx.net/licenses/all-rights-reserved
dc.subjectABO Blood-Group System
dc.subjectAdult
dc.subjectAged
dc.subjectCOVID-19
dc.subjectCritical Illness
dc.subjectFemale
dc.subjectHospital Mortality
dc.subjectHumans
dc.subjectImmunization, Passive
dc.subjectLength of Stay
dc.subjectLogistic Models
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectRespiration, Artificial
dc.subjectTreatment Failure
dc.subjectVasoconstrictor Agents
dc.titleEffect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial.
dc.typeArticle
dc.publisher.departmentDepartment of Medicine
dc.date.updated2022-01-09T14:03:54Z
prism.endingPage1702
prism.issueIdentifier17
prism.publicationDate2021
prism.publicationNameJAMA
prism.startingPage1690
prism.volume326
dc.identifier.doi10.17863/CAM.81234
dcterms.dateAccepted2021-09-24
rioxxterms.versionofrecord10.1001/jama.2021.18178
rioxxterms.versionAM
dc.contributor.orcidMenon, David [0000-0002-3228-9692]
dc.identifier.eissn1538-3598
rioxxterms.typeJournal Article/Review
pubs.funder-project-idCambridge University Hospitals NHS Foundation Trust (CUH) (unknown)
pubs.funder-project-idCambridge University Hospitals NHS Foundation Trust (CUH) (146281)
cam.issuedOnline2021-10-04
cam.orpheus.success2022-03-04: indefinite embargo already applied according to journal policy
cam.depositDate2022-01-09
pubs.licence-identifierapollo-deposit-licence-2-1
pubs.licence-display-nameApollo Repository Deposit Licence Agreement
rioxxterms.freetoread.startdate2100-01-01


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