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BACKGROUNDAlthough convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited.METHODSWe conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical COVID-19 at 5 sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single transfusion of either convalescent plasma or normal control plasma. The primary outcome was clinical status at 28 days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population.RESULTSOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive normal control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval [CI] 0.83-2.68, P = 0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, P = 0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected.CONCLUSIONIn adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A possible explanation is that survivors remained hospitalized at their baseline clinical status.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.
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http://dx.doi.org/10.1172/JCI150646 | DOI Listing |
Background And Objectives: Apheresis platelets products and plasma are essential for medical interventions, but both still have inherent risks associated with contamination and viral transmission. Platelet products are vulnerable to bacterial contamination due to storage conditions, while plasma requires extensive screening to minimize virus transmission risks. Here we investigate rapid irradiation to sterilizing doses for bacteria and viruses as an innovative pathogen reduction technology.
View Article and Find Full Text PDFMonaldi Arch Chest Dis
December 2024
Lab Operations and Microbiology, Agilus Diagnostics, Fortis Hospital, Noida, Uttar Pradesh.
Convalescent plasma therapy (CPT) is one of the treatment modalities used for COVID-19. Initial smaller studies showed the usefulness of CPT in COVID-19, but larger studies showed that it is not effective. This is a retrospective observational study conducted between 1st June 2020 and 31st July 2021 at a tertiary hospital in Noida, India.
View Article and Find Full Text PDFVirol J
December 2024
Department of Medical Microbiology and Infectious Diseases, University of Manitoba, Winnipeg, Canada.
Lassa virus, the cause of deadly Lassa fever, is endemic in West Africa, where thousands of cases occur on an annual basis. Nigeria continues to report increasingly severe outbreaks of Lassa Fever each year and there are currently no approved vaccines or therapeutics for the prevention or treatment of Lassa Fever. Given the high burden of disease coupled with the potential for further escalation due to climate change the WHO has listed Lassa virus as a priority pathogen with the potential to cause widespread outbreaks.
View Article and Find Full Text PDFEinstein (Sao Paulo)
December 2024
Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.
Objective: This study compared the outcomes of two cohorts of patients with coronavirus disease 2019 (COVID-19) who received COVID-19 convalescent plasma transfusions between 2020 and 2021.
Methods: This retrospective study was conducted at a tertiary hospital in São Paulo, Brazil. We included a retrospective cohort of patients who received convalescent compassionate plasma, and another group of patients from a previous clinical study.
Curr Top Microbiol Immunol
December 2024
Department of Health and Kinesiology, University of Illinois Urbana-Champaign, Urbana, IL, USA.
Despite concerns about potential side effects, based both on historical experience with plasma products and more recent concerns about contemporary use of plasma, COVID-19 convalescent plasma has been shown to be a very safe product. Research early in the COVID-19 pandemic documented-among the very large population of convalescent plasma recipients in the US Convalescent Plasma Study component of the FDA-authorized Expanded Access Program-that the overall risk profile was no different than that seen for fresh frozen plasma, a product used routinely in medical practice. The safety of CCP was further demonstrated using real-world evidence, pragmatic trials, and formal randomized trials.
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