A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia
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A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia. / 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.
In: Scientific Reports, Vol. 12, 16385, 2022.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia
AU - Thorlacius-Ussing, Louise
AU - Brooks, Patrick Terrence
AU - Nielsen, Henrik
AU - Jensen, Bitten Aagaard
AU - Wiese, Lothar
AU - Sækmose, Susanne Gjørup
AU - Johnsen, Stine
AU - Gybel-Brask, Mikkel
AU - Johansen, Isik S.
AU - Bruun, Mie Topholm
AU - Stærke, Nina Breinholdt
AU - Østergaard, Lars
AU - Erikstrup, Christian
AU - Ostrowski, Sisse Rye
AU - Homburg, Keld Mikkelsen
AU - Georgsen, Jørgen
AU - Mikkelsen, Susan
AU - Sandholdt, Håkon
AU - Leding, Cæcilie
AU - Hovmand, Nichlas
AU - Clausen, Clara Lundetoft
AU - Tinggaard, Michaela
AU - Pedersen, Karen Brorup Heje
AU - Iversen, Katrine Kjær
AU - Tingsgård, Sandra
AU - Israelsen, Simone Bastrup
AU - Benfield, Thomas
N1 - Publisher Copyright: © 2022, The Author(s).
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
U2 - 10.1038/s41598-022-19629-z
DO - 10.1038/s41598-022-19629-z
M3 - Journal article
C2 - 36180450
AN - SCOPUS:85139139930
VL - 12
JO - Scientific Reports
JF - Scientific Reports
SN - 2045-2322
M1 - 16385
ER -
ID: 323842947