A randomised controlled trial of plasma exchange compared to standard of care in the treatment of severe COVID-19 infection (COVIPLEX)

COVID-19 disease is associated with a hyperinflammatory, pro-thrombotic state and a high mortality. Our primary objective was to assess the change in inflammatory and thrombotic markers associated with PEX, and secondary objectives were to assess the effects of PEX on progression of respiratory fail...

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Bibliographic Details
Published in:	Scientific reports Vol. 14; no. 1; pp. 16876 - 9
Main Authors:	Arulkumaran, Nishkantha, Thomas, Mari, Stubbs, Matthew, Prasanna, Nithya, Subhan, Maryam, Singh, Deepak, Ambler, Gareth, Waller, Alessia, Singer, Mervyn, Brealey, David, Scully, Marie
Format:	Journal Article
Language:	English
Published:	London Nature Publishing Group UK 23-07-2024 Nature Publishing Group Nature Portfolio
Subjects:	631/250/2500 631/250/254 Adult Aged Apheresis Biomarkers - blood COVID-19 COVID-19 - blood COVID-19 - complications COVID-19 - mortality COVID-19 - therapy Female Ferritin Fibrin Fibrinogen Degradation Products - analysis Fibrin Fibrinogen Degradation Products - metabolism Humanities and Social Sciences Humans Male Middle Aged Mortality multidisciplinary Patients Plasma Exchange - methods Prospective Studies Respiration Respiratory failure Respiratory Insufficiency - blood Respiratory Insufficiency - therapy SARS-CoV-2 - isolation & purification Science Science (multidisciplinary) Standard of Care Thrombosis - etiology Treatment Outcome
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Summary:	COVID-19 disease is associated with a hyperinflammatory, pro-thrombotic state and a high mortality. Our primary objective was to assess the change in inflammatory and thrombotic markers associated with PEX, and secondary objectives were to assess the effects of PEX on progression of respiratory failure and incidence of acute thrombotic events. We conducted a prospective, phase II, non-blinded randomised control trial of plasma exchange compared to standard of care in critically ill adults with severe COVID-19 associated respiratory failure, requiring supplemental oxygen or ventilatory support and elevated thrombo-inflammatory markers (LDH, CRP, ferritin, and D-Dimer). Patients randomised to receive PEX were treated with a daily single volume plasma exchange for a minimum of five days. Twenty-two patients were randomised of who 11 received PEX. Demographic and clinical characteristics were similar between groups at presentation. PEX was associated with a significant reduction in pro-thrombotic markers FVIII, VWF and VWF Ag: ADAMTS 13 ratio ( p < 0.001). There were no differences in the reduction of inflammatory markers, severity of respiratory failure ( p = 0.7), thrombotic events ( p = 0.67), or mortality ( p > 0.99) at 28 days. PEX successfully reduced pro-thrombotic markers, although was not associated with reduction in inflammatory markers, respiratory failure, or thrombotic events. Trial registration : (NCT04623255); first posted on 10/11/2020.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	2045-2322 2045-2322
DOI:	10.1038/s41598-024-67028-3