Plasma exchange therapy for the post COVID-19 condition: a phase II, double-blind, placebo-controlled, randomized trial
Sergio España-Cueto, Cora Loste, Gemma Lladós, Cristina Vázquez, José Ramón Santos, Gemma Dulsat, Anna García, João Carmezim, Júlia Carabia, Águeda Ancochea, Carla Fernández-Prendres, Cristian Morales‐Indiano, Bibiana Quirant‐Sánchez, Eva Martínez‐Cáceres, Anna Sánchez, Ivonne Graciela Parraga, Anna Chamorro, Alba San José, Elena Abad, José A. Muñoz-Moreno, Anna Prats, Carmina R. Fumaz, Roser Coll-Fernández, Carla Estany, Pamela Torrano, Jordi Puig, Bonaventura Clotet, Cristian Tebé, Marta Massanella, Roger Paredes, Lourdes Mateu
Abstract
The post-COVID-19 condition (PCC) is a highly debilitating and persistent postinfectious syndrome that affects millions of people worldwide and has no effective treatment. Therapeutic plasma exchange (TPE) has the potential to improve the PCC by clearing the peripheral soluble pro-inflammatory immune milieu derived from acute or persistent SARS-CoV-2 infection. In a phase II, double-blind, placebo-controlled, randomized trial, fifty subjects with PCC were randomly assigned (1:1) to receive six sessions of either TPE or a sham plasma exchange and were followed for 90 days (ClinicalTrials.gov registration: NCT05445674). The primary endpoint was safety; secondary endpoints included functional status, symptomology, quality of life, neurocognitive symptoms, and peripheral biochemistry, hematology, coagulation and inflammation parameters. Both study arms had a similarly favorable safety profile. There were no diferences between groups in any of the efficacy parameters evaluated. Whereas TPE is safe, it did not lead to any discernible improvement of the PCC in this clinical trial. Here, the authors report results from a clinical trial testing whether therapeutic plasma exchange (TPE) can help people with post-COVID-19 condition (PCC). While TPE had a favorable safety profile, it didn’t improve symptoms or quality of life for people with PCC.