The first randomized clinical trial evaluating therapeutic plasma exchange (TPE) for Post-COVID-19 Condition (PCC) has found the treatment to be safe but ineffective in improving patient outcomes. The phase II study, conducted at Hospital Germans Trias i Pujol in Spain, challenges previous hopes that plasma exchange could offer relief for Long COVID sufferers.
The trial enrolled 50 patients with moderate to severe PCC between September 2022 and June 2023, randomly assigning them to receive either TPE or sham plasma exchange. Participants, predominantly women in their late forties, had experienced symptoms for an average of two years following their initial SARS-CoV-2 infection.
Treatment Protocol and Safety Findings
The TPE group underwent six treatment sessions over three weeks using the Spectra Optia® Apheresis System, while the control group received sham treatments with saline solution. The study demonstrated that TPE was generally well-tolerated, with no serious adverse events reported in either group. Common side effects included:
- Local administration site reactions (17.4% in TPE group)
- Gastrointestinal disturbances (16.6% in TPE group)
- Musculoskeletal disorders (13.1% in TPE group)
Efficacy Results
Despite its safety profile, TPE showed no meaningful therapeutic benefit across multiple outcome measures:
- Functional status improvements to PCFS grades 1-2 were observed in 24% of TPE patients versus 28% of placebo patients at day 45
- No significant differences between groups in symptom severity, fatigue levels, or quality of life measures
- Cognitive performance and memory complaints showed no differential improvement
- Laboratory parameters, including inflammatory markers, remained largely unchanged between groups
Clinical Implications
The study's findings raise important considerations about PCC treatment approaches:
- The timing of intervention may be crucial, as the average two-year delay from initial infection could have affected treatment efficacy
- Different plasmapheresis techniques, such as double filtration or immunoadsorption, might yield different results
- The complex nature of PCC may require more targeted interventions based on specific patient subgroups
Study Limitations
While the trial was rigorously designed with double-blinding, several limitations were noted:
- Small sample size of 50 participants
- Single-center recruitment
- Results may not generalize to other plasmapheresis approaches
- Potential variation in PCC subphenotypes among participants
The research team emphasized that Long COVID remains a significant public health challenge without specific treatment options. The findings underscore the need for continued investigation into alternative therapeutic approaches and better understanding of the condition's underlying mechanisms.
