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
  • Mikkel Gybel-Brask
  • 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.

OriginalsprogEngelsk
Artikelnummer16385
TidsskriftScientific Reports
Vol/bind12
ISSN2045-2322
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
The study was funded by the Lundbeck foundation. The funding source had no influence on study design, data collection, analysis, interpretation of study results, the writing of the report or the decision to submit the report for publication.

Funding Information:
Dr Nielsen declares grants from Novo Nordisk Foundation and personal fees from GSK and MDS outside of the submitted work. Dr Østergaard reports personal fees from Sanofi. Dr Erikstrup reports grants from Abbots diagnostic outside of the submitted work. Dr Benfield reports grants from Novo Nordisk Foundation, grants from Simonsen Foundation, grants and personal fees from GSK, grants and personal fees from Pfizer, personal fees from Boehringer Ingelheim, personal fees from Abbvie, grants and personal fees from Gilead, personal fees from MSD, grants from Lundbeck Foundation, grants from Kai Hansen Foundation, and grants from Erik and Susanna Olsen’s Charitable Fund outside the submitted work. All other authors have nothing to disclose.

Funding Information:
We thank patients who participated in the trial, the clinical research units and the health professionals in the involved departments and trial sites. Additionally, we thank the Data Safety Monitoring Board; Ole Kirk, Jannik Helweg-Larsen and Thomas Kallemose.

Publisher Copyright:
© 2022, The Author(s).

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