Therapeutic plasma exchange in patients with life-threatening COVID-19: a randomised controlled clinical trial |
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| Authors: | Fahad Faqihi Abdulrahman Alharthy Salman Abdulaziz Abdullah Balhamar Awad Alomari Zohair AlAseri Hani Tamim Saleh A. Alqahtani Demetrios J. Kutsogiannis Peter G. Brindley Dimitrios Karakitsos Ziad A. Memish |
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| Affiliation: | 1. Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia;2. Department of Critical Care, Dr Sulaiman Al-Habib Group Hospitals, Riyadh, Saudi Arabia;3. Departments of Emergency Medicine and Critical Care Medicine, King Saud University, Riyadh, Saudi Arabia;4. Biostatistics Unit, Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon;5. Division of Gastroenterology & Hepatology, Johns Hopkins University, Baltimore, MD, USA;6. Liver Transplant Center, and Biostatistics, Epidemiology, and Scientific Computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia;7. Department of Critical Care, Faculty of Medicine and Dentistry, the University of Alberta, Alberta, Canada;8. Department of Internal Medicine, South Carolina University, School of Medicine, Columbia, SC, USA;9. Critical Care Department, Keck Medical School, University of Southern California, Los Angeles, CA, USA;10. Research & Innovation Centre, King Saud Medical City, Riyadh, Saudi Arabia;11. Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA |
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| 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. |
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