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NCT05445674
Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study
Phase 2 trial testing Plasma Exchange Procedure in Post-COVID19 Condition in 50 participants. Completed in 6 June 2023.
6 June 2023
Quick facts
| Lead sponsor | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 22 September 2022 |
| Primary completion | 6 June 2023 |
| Estimated completion | 6 June 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Plasma Exchange Procedure
- Sham Plasma Exchange Procedure
Conditions studied
- Post-COVID19 Condition — all drugs for Post-COVID19 Condition →
Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia — full company profile →
Who can join
Adults 18 to 100, any sex, with Post-COVID19 Condition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
PAX is a prospective, randomized (1:1), double-blind, placebo-controlled study, that have as a objective to evaluate the safety and tolerability of plasma exchange (PE) in patients with Post Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange. The participants will be randomized in two arms: (1) 6 sessions of PE (Plasma Exchange) with human serum albumin 5% or (2) 6 sessions with placebo (infusion of of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fighting Post-COVID and ME/CFS - development of curative therapies.
Scheibenbogen C, Bellmann-Strobl JT, Heindrich C, Wittke K, et al · · 2023 · cited 32× · PMID 37396922 · DOI 10.3389/fmed.2023.1194754 -
Biological mechanisms underpinning the development of long COVID.
Perumal R, Shunmugam L, Naidoo K, Wilkins D, et al · · 2023 · cited 26× · PMID 37265584 · DOI 10.1016/j.isci.2023.106935 -
Plasmapheresis to remove amyloid fibrin(ogen) particles for treating the post-COVID-19 condition.
Fox T, Hunt BJ, Ariens RA, Towers GJ, et al · · 2023 · cited 14× · PMID 37491597 · DOI 10.1002/14651858.cd015775 -
Plasma exchange therapy for the post COVID-19 condition: a phase II, double-blind, placebo-controlled, randomized trial.
España-Cueto S, Loste C, Lladós G, López C, et al · · 2025 · cited 6× · PMID 39994269 · DOI 10.1038/s41467-025-57198-7
Verify or expand the search:
- PubMed search for NCT05445674
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05445674 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Last refreshed: 7 June 2023
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