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Covid-19: US approves emergency use of convalescent plasma despite warnings over lack of evidence

BMJ 2020; 370 doi: (Published 25 August 2020) Cite this as: BMJ 2020;370:m3327

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  1. Elisabeth Mahase
  1. The BMJ

The US Food and Drug Administration has approved convalescent plasma for emergency use in hospital patients with covid-19.1

The announcement on 23 August said that the FDA had concluded that plasma from recovered patients “may be effective” in treating the virus and that the “potential benefits of the product outweigh the known and potential risks.” The move came despite the absence of results from randomised controlled trials, with only a preprint paper on the effects on hospitalised covid-19 patients being published to date.

The preprint, published on medRxiv on 12 August, examined whether plasma reduced mortality, and included 35 000 patients who received transfusions between 4 April and 4 July at one of the 2800 participating US centres.2 The study, not yet peer reviewed, said, “Earlier use of convalescent plasma was associated …

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