Plasma exchange therapy for the post COVID-19 condition : a phase II, double-blind, placebo-controlled, randomized trial

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.