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

• Published in: Scientific reports 2022-09, Vol.12 (1), p.16385-16385, Article 16385
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: 692/308; 692/699/255; 692/699/255/2514; Coronaviruses; COVID-19; Humanities and Social Sciences; Immunotherapy; Intervention; multidisciplinary; Pandemics; Patients; Placebos; Plasma; Pneumonia; Science; Science (multidisciplinary)
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-022-19629-z

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.