TY  - BOOK
AU  - Shenoy, Aarthi
TI  - Early Outpatient Treatment for Covid-19 with Convalescent Plasma
SN  - 0028-4793
PY  - 2022///
KW  - *COVID-19
KW  - *Immunization, Passive
KW  - Adult
KW  - Ambulatory Care
KW  - COVID-19/th [Therapy]
KW  - Disease Progression
KW  - Double-Blind Method
KW  - Hospitalization
KW  - Humans
KW  - Immunization, Passive
KW  - Immunization, Passive/ae [Adverse Effects]
KW  - Immunization, Passive/mt [Methods]
KW  - Outpatients
KW  - Pharmaceutical Preparations
KW  - Treatment Outcome
KW  - United States
KW  - Washington Cancer Institute
KW  - Journal Article
N2  - 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
UR  - https://dx.doi.org/10.1056/NEJMoa2119657
ER  -