Current best evidence for clinical care (more info)
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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As a COVID-19 internist, I found this article very useful for my every day clinical practice.
Plasma exchange has not made it into any guidelines for the management of COVID-19. No strong evidence exists to support this method thus far. The present paper, limited by the number of patients studied, shows no mortality benefit, though some other benefits are noted. Overall, this is not a ringing endorsement for this method.
This RCT on TPE showed beneficial outcomes in reducing days in ICU and MV with a positively trending mortality benefit in COVID-19 patients. Strengths: the RCT is sufficiently powered for the primary outcome; innovation to eliminate the adverse effects of CPT. Weaknesses: the study was terminated early because of lack of patients; not blinded and single-centred - risk of huge; although TPE was used with the intention of reducing the inflammatory and thrombotic complication of CPT, actually TE complications were still high. Steroid use also possibly reduced inflammatory impacts and helped reduce inflammation, overlapping the primary outcome - the study was insufficiently powered even to comment on them; not sure when even CPT failed - how did TPE reduce the primary and secondary outcomes when antibodies were removed? - even CPT would have those interleukins. Impression: Important initiative but lacks clear goal.