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

    Scientific reports, 09/2022, Letnik: 12, Številka: 1
    Journal Article

    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.