Therapeutic plasma exchange in patients with life-threatening COVID-19: a randomized control clinical trial

Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: dr.faqihi677@gmail.com. Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: a_almshal@hotmail.com. Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: dr-salman@hotmail.com. Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Electronic address: abdullahbalahmar@gmail.com. Department of Critical care, Dr. Sulaiman Al-Habib Group Hospitals, Riyadh, Saud Arabia. Electronic address: dr_awad_ksa@yahooo.com. Departments of Emergency Medicine and Critical Care Medicine, King Saud University, Riyadh, Saudi Arabia. Electronic address: zohairalaseri@yahoo.com. Biostatistics Unit, Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: htamim@aub.edu.lb. Division of Gastroenterology & Hepatology, Johns Hopkins University, Baltimore, Maryland, USA; Liver Transplant Center, and Biostatistics, Epidemiology, and Scientific Computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. Electronic address: salqaht1@jhmi.edu. Department of Critical Care, Faculty of Medicine and Dentistry, the University of Alberta, Alberta, Canada. Electronic address: djk3@ualberta.ca. Department of Critical Care, Faculty of Medicine and Dentistry, the University of Alberta, Alberta, Canada. Electronic address: Peter.Brindley@albertahealthservices.ca. Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia; Department of Internal Medicine, South Carolina University, School of Medicine, Columbia, SC, USA; Critical Care Department, Keck Medical School, University of Southern California, Los Angeles, CA, USA. Electronic address: karakitsosdimitrios@gmail.com. Research & Innovation Centre, King Saud Medical City, Riyadh, Saudi Arabia; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA. Electronic address: zmemish@yahoo.com.

International journal of antimicrobial agents. 2021;:106334
Abstract
OBJECTIVE To assess the efficacy of therapeutic plasma exchange (TPE) following life-threatening COVID-19. DESIGN, SETTING, AND PARTICIPANTS Open-label, randomized clinical trial of intensive care unit (ICU) patients with life-threatening COVID-19 [positive real-time-polymerase-chain-reaction test, plus acute respiratory distress syndrome (ARDS), sepsis, organ failure, hyperinflammation]. The study was terminated after 87/120 patients were enrolled. INTERVENTION AND RANDOMIZATION Standard treatment plus TPE (n = 43) versus standard treatment (n = 44), and stratified by peripheral arterial oxygen saturation/fraction of inspired oxygen (PaO(2)/FiO(2)) ratio (> 150 versus ≤ 150). MAIN OUTCOMES AND MEASURES Primary outcomes were 35-day mortality and TPE safety. Secondary outcomes were association between TPE and mortality, improvement in Sequential Organ Function Assessment (SOFA) score, change in inflammatory biomarkers, days on mechanical ventilation (MV), and ICU length-of-stay. RESULTS Eighty-seven patients [median years of age 49 (IQR: 34-63); 72 males (82.8%)] were randomized [44 to standard care; 43 to standard care plus TPE]. Days on MV (p=0.007) and ICU length-of-stay (p=0.02) were lower in the TPE group versus controls. Thirty-five-day mortality was lower in the TPE group (20.9% vs. 34.1% in controls), but this did not reach statistical significance [Kaplan-Meir analysis: p=0.582). TPE was associated with increased lymphocytes and ADAMTS-13 activity; plus 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 [hazard 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), and PE (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) compared to controls. CONCLUSION In critically ill COVID-19 patients the addition of TPE to standard ICU therapy was associated with faster clinical recovery and no increased 35-day mortality.
Study details
Language : eng
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