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Randomized Controlled Trial
. 2022 Sep 30;12(1):16385.
doi: 10.1038/s41598-022-19629-z.

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

Louise Thorlacius-Ussing  1 , Patrick Terrence Brooks  2 , Henrik Nielsen  3   4 , Bitten Aagaard Jensen  5 , Lothar Wiese  6 , Susanne Gjørup Sækmose  7 , Stine Johnsen  8 , Mikkel Gybel-Brask  2 , Isik S Johansen  9 , Mie Topholm Bruun  10 , Nina Breinholdt Stærke  11 , Lars Østergaard  11 , Christian Erikstrup  12 , Sisse Rye Ostrowski  13 , Keld Mikkelsen Homburg  7 , Jørgen Georgsen  10 , Susan Mikkelsen  12 , Håkon Sandholdt  14 , Cæcilie Leding  14 , Nichlas Hovmand  14 , Clara Lundetoft Clausen  14 , Michaela Tinggaard  14 , Karen Brorup Heje Pedersen  14 , Katrine Kjær Iversen  14 , Sandra Tingsgård  14 , Simone Bastrup Israelsen  14 , Thomas Benfield  14   13
Affiliations
Randomized Controlled Trial

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

Louise Thorlacius-Ussing et al. Sci Rep. .

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.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Enrollment, Randomization, and Analysis Populations.
Figure 2
Figure 2
Clinical progression scale at baseline (A) and by 14 days (B).
Figure 3
Figure 3
Clinical progression scale on individual level by 14 days.
See this image and copyright information in PMC

References

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