Therapeutic plasma exchange in patients with life-threatening COVID-19: a randomised controlled clinical trial

• Type of Material: Article
• Authors: Fahad Faqihi, King Saud Hospital Riyadh; Abdulrahman Alharthy, King Saud Hospital Riyadh; Salman Abdulaziz, King Saud Hospital Riyadh; Abdullah Balhamar, King Saud Hospital Riyadh; Awad Alomari, Dr. Sulaiman Al-Habib Hospital; Zohair AlAseri, King Saud University; Hani Tamim, American University of Beirut Medical Center; Saleh A. Alqahtani, Johns Hopkins University; Demetrios J. Kutsogiannis, University of Alberta, Faculty of Medicine and Dentistry; Peter G. Brindley, University of Alberta, Faculty of Medicine and Dentistry; Dimitrios Karakitsos, King Saud Hospital Riyadh; Ziad Memish, Emory University
• Language: English
• Date: 2021-05-01
• Publisher: Elsevier
• Publication Version: Final Published Version
• Copyright Statement: © 2021 Elsevier Ltd and International Society of Antimicrobial Chemotherapy. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1016/j.ijantimicag.2021.106334
• Title of Journal or Parent Work: International Journal of Antimicrobial Agents
• Volume: 57
• Issue: 5
• Start Page: 106334
• End Page: 106334
• Grant/Funding Information: None.
• Keywords: Cytokine release syndrome; Treatment Outcome; Female; Therapeutic plasma exchange; Humans; Critical Care; Intensive care unit; Adult; Plasma Exchange; Thromboinflammation; Critical Illness; Kaplan-Meier Estimate; Male; Acute respiratory distress syndrome; Middle Aged; COVID-19
• Research Categories: Health Sciences, Public Health; Health Sciences, Epidemiology; Biology, Biostatistics; Health Sciences, Health Care Management

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 PaO2/FiO2 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: PaO2/FiO2 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.