Early Outpatient Treatment for Covid-19 with Convalescent Plasma.

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Citation: New England Journal of Medicine. 386(18):1700-1711, 2022 05 05.PMID: 35353960Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *COVID-19 | *Immunization, Passive | Adult | Ambulatory Care | COVID-19/th [Therapy] | Disease Progression | Double-Blind Method | Hospitalization | Humans | Immunization, Passive | Immunization, Passive/ae [Adverse Effects] | Immunization, Passive/mt [Methods] | Outpatients | Pharmaceutical Preparations | Treatment Outcome | United StatesYear: 2022ISSN:
  • 0028-4793
Name of journal: The New England journal of medicineAbstract: BACKGROUND: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.CONCLUSIONS: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.). Copyright ♭ 2022 Massachusetts Medical Society.METHODS: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (>=18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.RESULTS: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.All authors: Abinante M, Anjan S, Appel LJ, Baksh SN, Blair JE, Bloch EM, Broderick PB, Cachay ER, Casadevall A, Cluzet VC, Cordisco ME, Cruser D, Currier JS, Ehrhardt S, Ford DE, Forthal DN, Foster EC, Fukuta Y, Gawad AL, Gebo KA, Gerber JM, Gniadek TJ, Greenblatt B, Hammel J, Hammitt LL, Hanley DF, Heath SL, Huaman MA, Jabs DA, Karlen N, Kassaye SG, Klein SL, Laeyendecker O, Lane K, Lau B, Levine AC, Marshall CE, McBee NA, Meisenberg BR, Mosnaim GS, Oei K, Patel B, Paxton JH, Pekosz A, Petrini JR, Rausch W, Raval JS, Roth M, Shade DM, Shenoy AG, Shoham S, Singh A, Spivak ES, Sullivan DJ, Sutcliffe CG, Tobian AAR, Yarava A, Zand MSOriginally published: New England Journal of Medicine. 2022 Mar 30Fiscal year: FY2022Digital Object Identifier: Date added to catalog: 2022-05-11
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Journal Article MedStar Authors Catalog Article 35353960 Available 35353960

BACKGROUND: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.

CONCLUSIONS: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.). Copyright ♭ 2022 Massachusetts Medical Society.

METHODS: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (>=18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.

RESULTS: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.

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