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

Louise Thorlacius-Ussing*, Patrick Terrence Brooks, Henrik Nielsen, Bitten Aagaard Jensen, Lothar Wiese, Susanne Gjørup Sækmose, Stine Johnsen, Mikkel Gybel-Brask, Isik S. Johansen, Mie Topholm Bruun, Nina Breinholdt Stærke, Lars Østergaard, Christian Erikstrup, Sisse Rye Ostrowski, Keld Mikkelsen Homburg, Jørgen Georgsen, Susan Mikkelsen, Håkon Sandholdt, Cæcilie Leding, Nichlas HovmandClara Lundetoft Clausen, Michaela Tinggaard, Karen Brorup Heje Pedersen, Katrine Kjær Iversen, Sandra Tingsgård, Simone Bastrup Israelsen, Thomas Benfield

*Corresponding author for this work

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Abstract

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
Issue number1
Number of pages8
ISSN2045-2322
DOIs
Publication statusPublished - 30 Sep 2022

Bibliographical note

© 2022. The Author(s).

Keywords

  • Adult
  • COVID-19/therapy
  • Hospitalization
  • Humans
  • Immunization, Passive/methods
  • SARS-CoV-2
  • Treatment Outcome

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