Safety and tolerability evaluation of PE in patients with Post-Acute Covid-19 Syndrome (PCC) compared to sham plasma exchange (placebo).

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000641-33-ES

Enrollment

Registered

2022-03-02

Start date

2022-04-21

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Acute-Covid-19 Syndrome MedDRA version: 24.0 Level: PT Classification code 10085503 Term: Post-acute COVID-19 syndrome System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Albutein 5% Product Name: Albutein 5% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Albutein 5% Other descriptive name: HUMAN SERUM ALBUMIN Concentration unit: % percent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female individuals 18 years-old or older. 2. 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) SARS-CoV-2 serology before SARS-CoV-2 vaccination or (d) SARS CoV2 serology against N protein. 3. Symptoms of PCC after 90 days of infection and that last for at least 2 months and cannot explained by an alternative diagnosis. 4. Not able to perform all usual duties/ activities due to symptoms, pain, depression or anxiety, defined as grades 3 or 4 in Post-COVID-19 Functional Status scale (PCFS) 5. Availability of an adequate peripheral venous cannulation. 6. 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). 7. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. 8. Has understood the information provided and capable of giving informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. SARS-CoV-2 infection diagnosed during the previous 90 days. 2. Last SARS-CoV-2 vaccine dose during the previous 30 days 3. No significant limitations in the subject’s ability to perform all usual duties/ activities (i.e., grades 0, 1 or 2 in PCFS scale). 4. 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). 5. Pregnant or breastfeeding women. 6. 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. 7. Current or planned hospital admission for any cause during the study follow-up. 8. Inability to consent and/or comply with study requirements, in the opinion of the investigator. 9. Currently participating or planning to participate in any other clinical trial until day 90 of follow-up

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 1. Functional status: Proportion of subjects with Grade 1 o 2 functional disability by days 28 and 90, according to Post-COVID-19 Functional Status (PCFS) scale and evaluation fatigue severity scale (FSS) at days 0, 22,45 and 90. 2.Symptoms: Can Ruti PCC symptoms scale by days 0, 8, 15,22, 45 and 90 3.Quality of life: Quality of life questionnaires: EuroQol-5D questionnaire at day 0, 8, 15, 22, 45 and 90 and SF-36 questionnaire at days 0, 8, 15, 22, 45 and 90. 4.Immune analyses: Extensive lab analysis profile at days 0, 8, 15, 22, 45 and 90, including peripheral blood leukocyte and lymphocyte count, serum C-Reactive Protein (CRP) levels, macrophage activation and microangiopathy serum parameters (LDH, triglycerides, ferritin, D-Dimer) upon inclusion, pre and post treatment [Time Frame: Up to 90 days reception of investigational product]. Advanced inflammatory serum mediators will include: a battery of soluble markers associated with pro-inflammatory state and auto-immune disease. Plasma SARS-CoV-2 specific IgG and neutralization activity will be quantified as well. [Time Frame: Up to 90 days reception of investigational product]. 5.Immunophenotyping: a deep immunophenotyping of peripheral blood cells will be performed to detect changes in immune parameters at days 0, 8, 15, 22, 45 and 90. 6.Virological assessment: determination of residual SARS-CoV-2 particles (RNA or antigen) will be performed at days 0, 8, 15, 22, 45 and 90. 7.Dynamics of symptom variation during plasmapheresis. Functional status, symptoms profile and immune profiles obtained at day 8 (before the third plasmapheresis cycle) will be compared to dose at day 15 (before the 5th plasmapheresis cycle), as well as days 22, 45 and 90, aiming to explore if 2 cycles could already provide a similar benefit to 6. ;Timepoint(s) of evaluation of this end point: 1.Functional status: at days 0, 22, 45 and 90. 2.Symptoms: at days 0, 8, 15,22, 45 and 90 3.Quality of life: at day 0, 8, 15	—

Measure

Time frame

Secondary end point(s): 1. Functional status: Proportion of subjects with Grade 1 o 2 functional disability by days 28 and 90, according to Post-COVID-19 Functional Status (PCFS) scale and evaluation fatigue severity scale (FSS) at days 0, 22,45 and 90. 2.Symptoms: Can Ruti PCC symptoms scale by days 0, 8, 15,22, 45 and 90 3.Quality of life: Quality of life questionnaires: EuroQol-5D questionnaire at day 0, 8, 15, 22, 45 and 90 and SF-36 questionnaire at days 0, 8, 15, 22, 45 and 90. 4.Immune analyses: Extensive lab analysis profile at days 0, 8, 15, 22, 45 and 90, including peripheral blood leukocyte and lymphocyte count, serum C-Reactive Protein (CRP) levels, macrophage activation and microangiopathy serum parameters (LDH, triglycerides, ferritin, D-Dimer) upon inclusion, pre and post treatment [Time Frame: Up to 90 days reception of investigational product]. Advanced inflammatory serum mediators will include: a battery of soluble markers associated with pro-inflammatory state and auto-immune disease. Plasma SARS-CoV-2 specific IgG and neutralization activity will be quantified as well. [Time Frame: Up to 90 days reception of investigational product]. 5.Immunophenotyping: a deep immunophenotyping of peripheral blood cells will be performed to detect changes in immune parameters at days 0, 8, 15, 22, 45 and 90. 6.Virological assessment: determination of residual SARS-CoV-2 particles (RNA or antigen) will be performed at days 0, 8, 15, 22, 45 and 90. 7.Dynamics of symptom variation during plasmapheresis. Functional status, symptoms profile and immune profiles obtained at day 8 (before the third plasmapheresis cycle) will be compared to dose at day 15 (before the 5th plasmapheresis cycle), as well as days 22, 45 and 90, aiming to explore if 2 cycles could already provide a similar benefit to 6. ;Timepoint(s) of evaluation of this end point: 1.Functional status: at days 0, 22, 45 and 90. 2.Symptoms: at days 0, 8, 15,22, 45 and 90 3.Quality of life: at day 0, 8, 15

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Primary

Measure	Time frame
Main Objective: Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) compared to sham plasma exchange (placebo).;Secondary Objective: 1.Assess the ability of PE to improve the functional status of subjects with PCC. 2.Assess the ability of PE to improve PCC symptoms. 3.Assess the impact of PE on quality of life in subjects with PCC. 4.Assess changes in inflammation, autoimmunity, humoral and cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC 5.Assess the presence of viral particles in plasma from subjects with PCC 6.Understand the dynamics of symptoms and blood biomarker variations during the 6 sessions, to explore if a benefit could already be observed after the first 2 or 4 sessions. ;Primary end point(s): The proportion of adverse events (AEs) through day 90, considering: All AEs Grade 3 and 4 AEs AEs leading to study discontinuation ;Timepoint(s) of evaluation of this end point: at day 90	—

Measure

Time frame

Main Objective: Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) compared to sham plasma exchange (placebo).;Secondary Objective: 1.Assess the ability of PE to improve the functional status of subjects with PCC. 2.Assess the ability of PE to improve PCC symptoms. 3.Assess the impact of PE on quality of life in subjects with PCC. 4.Assess changes in inflammation, autoimmunity, humoral and cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC 5.Assess the presence of viral particles in plasma from subjects with PCC 6.Understand the dynamics of symptoms and blood biomarker variations during the 6 sessions, to explore if a benefit could already be observed after the first 2 or 4 sessions. ;Primary end point(s): The proportion of adverse events (AEs) through day 90, considering: All AEs Grade 3 and 4 AEs AEs leading to study discontinuation ;Timepoint(s) of evaluation of this end point: at day 90

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Countries

Spain

Contacts

Public ContactFLS-RS

Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència

gdulsat@fls-rs.com34934978414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026