A new score to predict severe respiratory failure and guide anakinra treatment in COVID-19 pneumonia: analysis of the randomized SAVE-MORE trial
Critical Care Conference: 42nd International Symposium on Intensive Care and Emergency Medicine Brussels Belgium
; 27(Supplement 1), 2023.
Article
in English
| EMBASE | ID: covidwho-2316327
ABSTRACT
Introduction:
Anakinra treatment is approved for the treatment of COVID-19 pneumonia in hospitalized adults in need of oxygen and at risk for progression into severe respiratory failure (SRF) defined as circulating concentrations of the biomarker suPAR (soluble urokinase plasminogen activator receptor) >= 6 ng/mL by the EMA and has been authorized for emergency use by FDA under an EUA [1]. This is based on the results of the randomized SAVE-MORE trial where suPAR >= 6 ng/ mL was used to select patients at risk for SRF [2]. The suPAR test is not commercially available in the USA and an alternative method of patient selection was needed. Method(s) In collaboration with the US FDA, an alternative method to select patients most likely to have suPAR >= 6 ng/mL based on commonly measured patient characteristics was developed. Patients with at least 3 of the following criteria are considered likely to have suPAR >= 6 ng/ ml age >= 75 years, severe pneumonia by WHO criteria, current/previous smoking status, Sequential Organ Failure Assessment score >= 3, neutrophil-to-lymphocyte ratio >= 7, hemoglobin <= 10.5 g/dl, history of ischemic stroke, blood urea >= 50 mg/dl and/or history of renal disease. Result(s) The positive predictive value of this new score was 95.4% in SAVE-MORE population. However, a lower sensitivity meant a small proportion of patients with suPAR >= 6 ng/ml will not be identified by the new score. The adjusted hazard ratio for survival at 60 days for patients meeting this score and who receive anakinra is 0.45 (Fig. 1). Conclusion(s) The developed score predicts accurately patients with suPAR levels >= 6 ng/mL and may be used as an alternative to guide anakinra treatment in patients with COVID-19 pneumonia. Based on these subgroup results, patients in SAVE-MORE who met the new score appeared to show beneficial efficacy results with treatment of anakinra consistent with the overall studied population.
adult; clinical trial; conference abstract; controlled study; coronavirus disease 2019; diagnostic test accuracy study; drug therapy; female; Food and Drug Administration; human; ischemic stroke; kidney disease; male; neutrophil lymphocyte ratio; patient selection; people by smoking status; pneumonia; predictive value; randomized controlled trial; respiratory failure; Sequential Organ Failure Assessment Score; survival; urea blood level; anakinra; endogenous compound; hemoglobin
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Language:
English
Journal:
Critical Care Conference: 42nd International Symposium on Intensive Care and Emergency Medicine Brussels Belgium
Year:
2023
Document Type:
Article
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