A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia

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  • Louise Thorlacius-Ussing
  • Henrik Nielsen
  • Bitten Aagaard Jensen
  • Lothar Wiese
  • Susanne Gjørup Sækmose
  • Isik S. Johansen
  • Mie Topholm Bruun
  • Nina Breinholdt Stærke
  • Lars Østergaard
  • Christian Erikstrup
  • Keld Mikkelsen Homburg
  • Jørgen Georgsen
  • Susan Mikkelsen
  • Håkon Sandholdt
  • Cæcilie Leding
  • Nichlas Hovmand
  • Clara Lundetoft Clausen
  • Michaela Tinggaard
  • Karen Brorup Heje Pedersen
  • Katrine Kjær Iversen
  • Sandra Tingsgård
  • Simone Bastrup Israelsen

Passive immunotherapy with convalescent plasma may be the only available agent during the early phases of a pandemic. Here, we report safety and efficacy of high-titer convalescent plasma for COVID-19 pneumonia. Double-blinded randomized multicenter placebo-controlled trial of adult patients hospitalized with COVID-19 pneumonia. The intervention was COVID-19 convalescent plasma and placebo was saline allocated 2:1. The primary outcome was clinical status 14 days after the intervention evaluated on a clinical ordinal scale. The trial was registered at ClinicalTrials.Gov, NCT04345289, 14/04/2020. The CCAP-2 trial was terminated prematurely due to futility. Of 147 patients randomized, we included 144 patients in the modified intention-to-treat population. The ordinal clinical status 14 days post-intervention was comparable between treatment groups (odds ratio (OR) 1.41, 95% confidence interval (CI) 0.72–2.09). Results were consistent when evaluating clinical progression on an individual level 14 days after intervention (OR 1.09; 95% CI 0.46–1.73). No significant differences in length of hospital stay, admission to ICU, frequency of severe adverse events or all-cause mortality during follow-up were found between the intervention and the placebo group. Infusion of convalescent plasma did not influence clinical progression, survival or length of hospitalization in patients with COVID-19 pneumonia.

Original languageEnglish
Article number16385
JournalScientific Reports
Volume12
ISSN2045-2322
DOIs
Publication statusPublished - 2022

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© 2022, The Author(s).

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