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NCT05445674

Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study

Completed Phase 2 Last updated 7 June 2023
What this trial tests

Phase 2 trial testing Plasma Exchange Procedure in Post-COVID19 Condition in 50 participants. Completed in 6 June 2023.

Timeline
22 September 2022
Primary endpoint
6 June 2023
6 June 2023

Quick facts

Lead sponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment50
Start date22 September 2022
Primary completion6 June 2023
Estimated completion6 June 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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

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Trials by the same sponsor.

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