What is the status of convalescent plasma in the treatment of coronavirus disease 2019 (COVID-19)?

Updated: Jul 01, 2020
  • Author: Medscape Drugs & Diseases; more...
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Answer

The FDA is facilitating access to convalescent plasma, antibody-rich products that are collected from eligible donors who have recovered from COVID-19. Convalescent plasma has not yet been shown to be effective in COVID-19. The FDA states that it is important to determine its safety and efficacy via clinical trials before routinely administering convalescent plasma to patients with COVID-19.

The FDA has posted information for investigators wishing to study convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug (IND) applications for individual patients. The FDA also is actively engaging with researchers to discuss the possibility of collaboration on the development of a master protocol for the use of convalescent plasma, with the goal of reducing duplicative efforts. [67]

The use of convalescent plasma has a long history in the treatment of infectious diseases. Writing in the Journal of Clinical Investigation Casadevall and Pirofski [68] proposed using it as a treatment for COVID-19, and Bloch et al [69] laid out a conceptual framework for implementation. To date, two small case series have been published. [70, 71] These series reported improvement in oxygenation, sequential organ failure assessment (SOFA) scores, and eventual ventilator weaning in some patients. The timelines of improvement varied from days to weeks. Caution is advised, as these were not controlled trials and other pharmacologic methods (antivirals) were used in some patients. [71]

An open-label study (n = 103) of patients with laboratory-confirmed COVID-19 in Wuhan, China, given convalescent plasma did not result in a statistically significant improvement in time to clinical improvement within 28 days compared with standard of care alone. [72]

A nonrandomized study transfused patients based on supplemental oxygen needs with convalescent plasma from donors with a SARS-CoV-2 anti-spike antibody titer of at least 1:320 dilution. Matched control patients were retrospectively identified within the electronic health record database. Supplemental oxygen requirements and survival were compared between plasma recipients and controls. Results showed convalescent plasma transfusion improved survival in nonintubated patients (P = 0.015), but not in intubated patients (P = 0.752). [73]


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