Abstract
Assessment of efficacy of therapeutic plasma exchange (TPE) following life-threatening COVID-19. This was an open-label, randomised clinical trial of ICU patients with life-threatening COVID-19 (positive RT-qPCR plus ARDS, sepsis, organ failure, hyperinflammation). Study was terminated after 87/120 patients enrolled. Standard treatment plus TPE (n = 43) versus standard treatment (n = 44), and stratified by PaO 2 /FiO 2 ratio (>150 vs. ≤150), were compared. Primary outcomes were 35-day mortality and TPE safety. Secondary outcomes were association between TPE and mortality, improvement in SOFA score, change in inflammatory biomarkers, days on mechanical ventilation (MV), and ICU length of stay (LOS). Eighty-seven patients [median age 49 (IQR 34-63) years; 82.8% male] were randomised (44 standard care; 43 standard care plus TPE). Days on MV (P = 0.007) and ICU LOS (P = 0.02) were lower in the TPE group. 35-Day mortality was non-significantly lower in the TPE group (20.9% vs. 34.1%; Kaplan-Meier, P = 0.582). TPE was associated with increased lymphocytes and ADAMTS-13 activity and decreased serum lactate, lactate dehydrogenase, ferritin, d-dimers and interleukin-6. Multivariable regression analysis provided several predictors of 35-day mortality: PaO 2 /FiO 2 ratio (HR, 0.98, 95% CI 0.96-1.00; P = 0.02]; ADAMTS-13 activity (HR, 0.89, 95% CI 0.82-0.98; P = 0.01); pulmonary embolism (HR, 3.57, 95% CI 1.43-8.92; P = 0.007). Post-hoc analysis revealed a significant reduction in SOFA score for TPE patients (P < 0.05). In critically-ill COVID-19 patients, addition of TPE to standard ICU therapy was associated with faster clinical recovery and no increased 35-day mortality.
Keywords: Acute respiratory distress syndrome; COVID-19; Cytokine release syndrome; Intensive care unit; Therapeutic plasma exchange; Thromboinflammation.
【저자키워드】 COVID-19, acute respiratory distress syndrome, intensive care unit, Cytokine release syndrome, Thromboinflammation, Therapeutic plasma exchange, 【초록키워드】 Treatment, Efficacy, ARDS, clinical trial, therapy, Mortality, Open-label, randomised, interleukin-6, D-dimer, ferritin, Sepsis, outcome, lactate dehydrogenase, ICU, lymphocyte, RT-qPCR, hyperinflammation, Patient, plasma, age, predictor, assessment, Care, COVID-19 patients, association, inflammatory biomarkers, Analysis, distress, Standard, Organ failure, SOFA score, LOS, 95% CI, standard care, standard treatment, life-threatening, Multivariable regression analysis, Kaplan-Meier, positive, secondary, ICU patient, enrolled, addition, Day, provided, reduction in, stratified, faster clinical recovery, IQR, on mechanical ventilation, PaO, serum lactate, TPE, 【제목키워드】 clinical trial, Patient, plasma, life-threatening, randomised controlled,