29-mRNA host response signatures for classification of bacterial infection, viral infection and disease progression in COVID-19 pneumonia: a post hoc analysis of the SAVE-MORE randomized clinical trial.
Evdoxia Kyriazopoulou, Antigone Kotsaki, Asimina Safarika, Garyfallia Poulakou, Haralampos Milionis, Simeon Metallidis, Georgios Adamis, Archontoula Fragkou, Aggeliki Rapti, Pierluigi Del Vecchio, Ioannis Kalomenidis, Danae Kitzoglou, Andrea Angheben, Ilias Kainis, Konstantina Iliopoulou, Francesco Saverio Serino, Petros Bakakos, Vassiliki Tzavara, Sofia Ioannou, Lorenzo Dagna, Katerina Dimakou, Glykeria Tzatzagou, Maria Chini, Matteo Bassetti, Vasileios Kotsis, George Tsoukalas, Carlo Selmi, Sofia Nikolakopoulou, Michael Samarkos, Michael Doumas, Aikaterini Masgala, Ilias Papanikolaou, Aikaterini Argyraki, Karolina Akinosoglou, Styliani Symbardi, Periklis Panagopoulos, George N Dalekos, Oliver Liesenfeld, Timothy E Sweeney, Purvesh Khatri, Evangelos J Giamarellos-Bourboulis
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Abstract
Background: Biomarkers based on host response signatures are currently under development for the critically ill. We applied a 29-mRNA classifier for the diagnosis and prognosis of suspected acute infection and sepsis (TriVerity™, Inflammatix Inc.) in patients hospitalized with COVID-19.
Methods: We applied three scores from locked classifiers (IMX-BVN-4 and IMX-SEV-4) from the 29-mRNA TriVerity™ blood test in participants of the SAVE-MORE randomized clinical trial (ClinicalTrials.gov NCT04680949) at baseline and days 4 and 7 of treatment, to classify bacterial infection, viral infection and decompensation. Participants were adults hospitalized with confirmed COVID-19 pneumonia and plasma soluble urokinase plasminogen activator receptor (suPAR) levels of ≥ 6 ng/ml, randomized to placebo or anakinra treatment.
Results: A total of 471 patients were studied. At baseline nearly 90% had a Very Low or Low IMX-BVN-4 Bacterial Score and Moderate, High or Very High IMX-BVN-4 Viral Score. Anakinra treatment had an effect on the expression of genes indicating IMX-SEV-4 High or Very High scores after a 7 day treatment compared to baseline (12.9% of anakinra-treated patients continued being classified as high severity vs 20.4% of placebo-treated patients, p 0.046).
Conclusions: The classifiers were well tested in COVID-19 pneumonia and may become a useful tool for hospitalized patients.
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