COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes

Daniele Focosi, Massimo Franchini, Liise Anne Pirofski, Thierry Burnouf, Nigel Paneth, Michael J. Joyner, Arturo Casadevall

研究成果: 雜誌貢獻回顧型文獻同行評審

19 引文 斯高帕斯(Scopus)

摘要

Convalescent plasma (CP) recurs as a frontline treatment in epidemics because it is available as soon as there are survivors. The COVID-19 pandemic represented the first large-scale opportunity to shed light on the mechanisms of action, safety, and efficacy of CP using modern evidence-based medicine approaches. Studies ranging from observational case series to randomized controlled trials (RCTs) have reported highly variable efficacy results for COVID-19 CP (CCP), resulting in uncertainty. We analyzed variables associated with efficacy, such as clinical settings, disease severity, CCP SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody levels and function, dose, timing of administration (variously defined as time from onset of symptoms, molecular diagnosis, diagnosis of pneumonia, or hospitalization, or by serostatus), outcomes (defined as hospitalization, requirement for ventilation, clinical improvement, or mortality), CCP provenance and time for collection, and criteria for efficacy. The conflicting trial results, along with both recent WHO guidelines discouraging CCP usage and the recent expansion of the FDA emergency use authorization (EUA) to include outpatient use of CCP, create confusion for both clinicians and patients about the appropriate use of CCP. A review of 30 available RCTs demonstrated that signals of efficacy (including reductions in mortality) were more likely if the CCP neutralizing titer was >160 and the time to randomization was less than 9 days. The emergence of the Omicron variant also reminds us of the benefits of polyclonal antibody therapies, especially as a bridge to the development and availability of more specific therapies.
原文英語
頁(從 - 到)e0020021
期刊Clinical Microbiology Reviews
35
發行號3
DOIs
出版狀態已發佈 - 9月 2022

ASJC Scopus subject areas

  • 流行病學
  • 免疫學與微生物學 (全部)
  • 公共衛生、環境和職業健康
  • 微生物學(醫學)
  • 傳染性疾病

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