Plasma exchange therapy for the post COVID-19 condition: a phase II, double-blind, placebo-controlled, randomized trial
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.
Authors
- Isabel M. Parraga
- Anna Chamorro
- Cora Loste (ORCID: https://orcid.org/0000-0002-5406-1875)
- Sergio España-Cueto (ORCID: https://orcid.org/0000-0002-3026-132X)
- Bonaventura Clotet (ORCID: https://orcid.org/0000-0003-3232-4598)
- Elena Abad
- Cristian Morales‐Indiano (ORCID: https://orcid.org/0000-0003-0497-6003)
- Cristina Vázquez (ORCID: https://orcid.org/0000-0001-6333-7960)
- Anna Prats (ORCID: https://orcid.org/0000-0002-3586-4525)
- Júlia Carabia
- Águeda Ancochea
- Lourdes Mateu (ORCID: https://orcid.org/0000-0001-7223-7611)
- Eva Martínez‐Cáceres (ORCID: https://orcid.org/0000-0002-6762-8025)
- Pamela Torrano
- Alba San José
- Bibiana Quirant‐Sánchez (ORCID: https://orcid.org/0000-0002-3875-8074)
- Roser Coll-Fernández (ORCID: https://orcid.org/0000-0003-4943-2376)
- Carmina R. Fumaz (ORCID: https://orcid.org/0000-0003-0838-3395)
- Jordi Puig (ORCID: https://orcid.org/0000-0002-4075-0346)
- Anna García (ORCID: https://orcid.org/0000-0002-1602-2461)
- José A. Muñoz-Moreno (ORCID: https://orcid.org/0000-0002-7239-5422)
- João Carmezim
- Marta Massanella (ORCID: https://orcid.org/0000-0002-3326-151X)
- Carla Estany (ORCID: https://orcid.org/0000-0001-6993-5865)
- Roger Paredes (ORCID: https://orcid.org/0000-0002-6553-691X)
- José Ramón Santos
- Anna Sánchez (ORCID: https://orcid.org/0000-0003-3781-6612)
- Gemma Lladós
- Cristian Tebé
- Carla Fernández-Prendres
- Gemma Dulsat
Institutions
- Universitat de Vic - Universitat Central de Catalunya (ES)
- Universitat Autònoma de Barcelona (ES)
- Universitat Oberta de Catalunya (ES)
- Instituto de Salud Carlos III (ES)
- IrsiCaixa (ES)
- Red de Investigación en Sida (ES)
- Center for Global Health (US)
- Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (ES)
- Banc de Sang i Teixits (ES)
- Hospital Universitari Germans Trias i Pujol (ES)
- Fundació Lluita contra les Infeccions (ES)
- Case Western Reserve University (US)
Publication Details
- Journal
- Nature Communications
- Published
- 2025-02-24
- DOI
- https://doi.org/10.1038/s41467-025-57198-7
- Citations
- 10
- Primary Topic
- Long-Term Effects of COVID-19
- Type
- article
- Field-Weighted Citation Impact
- 13.89
Funders
- Ministerio de Ciencia e Innovación
- Grifols
- Agencia Estatal de Investigación