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

Autor: Thorlacius-Ussing L; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark. louise.thorlacius-ussing@regionh.dk., Brooks PT; Department of Clinical Immunology, Copenhagen University Hospital -Rigshospitalet, Copenhagen, Denmark., Nielsen H; Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark., Jensen BA; Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark., Wiese L; Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark., Sækmose SG; Department of Clinical Immunology, Zealand University Hospital, Køge, Denmark., Johnsen S; Department of Respiratory Medicine, Copenhagen University Hospital -Bispebjerg and Frederiksberg, Copenhagen, Denmark., Gybel-Brask M; Department of Clinical Immunology, Copenhagen University Hospital -Rigshospitalet, Copenhagen, Denmark., Johansen IS; Department of Infectious Diseases, Odense University Hospital, Odense, Denmark., Bruun MT; Department of Clinical Immunology, Odense University Hospital, Odense, Denmark., Stærke NB; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark., Østergaard L; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark., Erikstrup C; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark., Ostrowski SR; Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Homburg KM; Department of Clinical Immunology, Zealand University Hospital, Køge, Denmark., Georgsen J; Department of Clinical Immunology, Odense University Hospital, Odense, Denmark., Mikkelsen S; Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark., Sandholdt H; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Leding C; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Hovmand N; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Clausen CL; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Tinggaard M; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Pedersen KBH; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Iversen KK; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Tingsgård S; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Israelsen SB; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark., Benfield T; Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital -Amager and Hvidovre, Hvidovre, Denmark.; Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2022 Sep 30; Vol. 12 (1), pp. 16385. Date of Electronic Publication: 2022 Sep 30.
DOI: 10.1038/s41598-022-19629-z
Abstrakt: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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