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

NCT05445674 | Completed Phase 2

• 1 other identifier: PAX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-COVID19 Condition

Keywords

SARS-CoV-2; COVID-19; Long COVID19; Plasma exchange (PE); Plasmapheresis

Outcome Measures

Primary Outcomes (3)

• Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange (placebo)

  Proportion of adverse events (AEs) through day 90, considering: * All AEs * Grade 3 and 4 AEs * AEs leading to study discontinuation

  Within 90 days from the treatment start

• Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS)

  Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS), being 0 the better outcome and 4 the worse outcome

  From baseline to day 90

• Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS)

  Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS), being 1 the better outcome and 70 the worse outcome

  From baseline to day 90

Secondary Outcomes (11)

• Assess the ability of PE to improve PCC symptoms

  At days 0, 8, 15, 22, 45 and 90

• Assess the impact of PE on quality of life in subjects with PCC

  At day 0, 8, 15, 22, 45 and 90.

• Assess the impact of PE on quality of life in subjects with PCC using MOS-HIV questionnaire

  At day 0, 8, 15, 22, 45 and 90.

• Assess the impact of PE on neurocognitive symptoms in subjects with PCC using NeuScreen fluency Test

  At days 0, 22 and 90

• Assess the impact of PE on neurocognitive symptoms in subjects with PCC using MEF-30 questionnaire

  At days 0, 22 and 90

Study Arms (2)

Plasma Exchange

EXPERIMENTAL

6 sessions of PE with human serum 5% albumin. Plasma exchange sessions will occur on days 1, 3, 8, 10, 15 and 17

Combination Product: Plasma Exchange Procedure

Sham Plasma Exchange

SHAM COMPARATOR

6 sessions of sham plasma exchange (one infusion of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.

Other: Sham Plasma Exchange Procedure

Interventions

Plasma Exchange Procedure COMBINATION_PRODUCT

Plasma exchanges will be performed with 5% albumin as the replacement fluid. The typical schedule prescribed will be an exchange of 1 volemia. Blood will be separated into cells and plasma; the cells will be combined with reconstituted 5% human serum albumin and reinfused into the patient with normal saline

Also known as: Plasmapheresis

Plasma Exchange

Sham Plasma Exchange Procedure OTHER

For sham plasma exchange procedures, a sound behind the curtain will be performed imitating the sound of the cell processing platform. In these cases, only one infusion of 200 to 250ml of sterile saline solution 0.9% will be performed during the time stablished for all procedures. Albumin will not be necessary for those patients in the Sham plasma exchange arm

Sham Plasma Exchange

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female individuals 18 years-old or older.
• Evidence of previous SARS-CoV-2 infection at least 90 days prior to study recruitment, defined by either (a) Nasopharyngeal SARS-CoV-2 nucleic acid test (Polymerase chain reaction \[PCR\] or Transcription-Mediated Amplification \[TMA\] (b) validated Nasopharyngeal Lateral Flow Assay rapid antigen test \[RAT\], or (c) SARSCoV-2 serology before SARS-CoV-2 vaccination.
• Symptoms of PCC after 90 days of infection and that last for at least 2 months and cannot explained by an alternative diagnosis.
• Not able to perform all usual duties/ activities due to symptoms, pain, depression or anxiety, defined as grades 3 or 4 in the post-COVID-19 Functional Status (PCFS) scale.
• Availability of an adequate peripheral venous cannulation.
• If women of childbearing potential, use of a highly effective method of contraception (abstinence, hormonal contraception, intra-uterine device \[IUD\], or anatomical sterility in self).
• Willing to comply with the requirements of the protocol and available for followup for the planned duration of the study.

You may not qualify if:

• SARS-CoV-2 infection diagnosed during the previous 90 days.
• Last SARS-CoV-2 vaccine dose during the previous 30 days.
• No significant limitations in the subject's ability to perform all usual duties/activities (i.e., grades 0, 1 or 2 in PCFS scale).
• Medical conditions for which 250 mL of intravenous fluid is considered dangerous (i.e., decompensated heart failure or renal failure with fluid overload, among others).
• Pregnant or breastfeeding women.
• Contraindications for therapeutic PE: Non-availability of an adequate peripheral venous catheter, hemodynamic instability, septicemia, known allergy to fresh frozen plasma or replacement colloid/albumin, known allergy to heparin.
• Current or planned hospital admission for any cause during the study follow-up.
• Inability to consent and/or comply with study requirements, in the opinion of the investigator.
• Currently participating or planning to participate in any other clinical trial until day 90 of follow-up.

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead
• IrsiCaixa: collaborator
• Banc de Sang i Teixits: collaborator

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

• Espana-Cueto S, Loste C, Llados G, Lopez C, Santos JR, Dulsat G, Garcia A, Carmezim J, Carabia J, Ancochea A, Fernandez-Prendres C, Morales-Indiano C, Quirant B, Martinez-Caceres E, Sanchez A, Parraga IG, Chamorro A, San Jose A, Abad E, Munoz-Moreno JA, Prats A, Fumaz CR, Coll-Fernandez R, Estany C, Torrano P, Puig J, Clotet B, Tebe C, Massanella M, Paredes R, Mateu L. Plasma exchange therapy for the post COVID-19 condition: a phase II, double-blind, placebo-controlled, randomized trial. Nat Commun. 2025 Feb 24;16(1):1929. doi: 10.1038/s41467-025-57198-7.

  PMID: 39994269 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Lourdes Mateu Pruñonosa, PhD, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double blind, placebo-controlled study. Masking of investigational products will ensure that both the investigator and the participant are blinded to the type of exchange procedure. Patients will be unable to distinguish true from sham procedures at the end of the study. Each procedure will take approximately 2 hours to complete. In the sham procedure, the patients will also underwear 6 procedures lasting approximately 2 hours each. Blinding will be maintained throughout the study until after 3-month follow-up assessment of the last patient exchanged
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized (1:1), double-blind, placebo-controlled study

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: September 22, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

ES (1)