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Completed

NCT Number: NCT05445674

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

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.

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Key information

Conditions

Post-COVID19 Condition COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

About this study

Randomized participants will receive plasma exchange (PE) or sham PE (placebo) (6 sessions: V2, V3, V4, V5, V6 and V7) and will continue their follow-up visits(V8d22, V9d45, V10d90). Plasma volumes will be replaced, which will vary depending on sex, height, weight and hematocrit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Has understood the information provided and capable of giving informed consent. Exclusion criteria

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Plasmapheresis

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

Primary outcomes

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

    Time frame: Within 90 days from the treatment start

    Proportion of adverse events (AEs) through day 90, considering:

    • All AEs
    • Grade 3 and 4 AEs
    • AEs leading to study discontinuation

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

    Time frame: From baseline to day 90

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

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

    Time frame: From baseline to day 90

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

Secondary outcomes

  1. Assess the ability of PE to improve PCC symptoms

    Time frame: At days 0, 8, 15, 22, 45 and 90

    Can Ruti PCC symptoms scale questionnare by days 0, 8, 15, 22, 45 and 90

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

    Time frame: At day 0, 8, 15, 22, 45 and 90.

    Quality of life questionnaires: EuroQol-5D questionnaire being 5 the better outcome and 15 the worse outcome.

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

    Time frame: At day 0, 8, 15, 22, 45 and 90.

    Quality of life questionnaires: MOS-HIV questionnaire being 4 the better outcome and 1 the worse outcome.

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

    Time frame: At days 0, 22 and 90

    The neurocognitive evaluation assessed by the NeuScreen fluency test (Seconds)

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

    Time frame: At days 0, 22 and 90

    The neurocognitive evaluation assessed by the MEF-30 questionnaire, with being 0 the better outcome and 120 being the worse outcome.

  6. Assess the impact of PE on neurocognitive symptoms in subjects with PCC using HADs questionnaire

    Time frame: At days 0, 22 and 90

    The neurocognitive evaluation assessed by the HADs questionnaire, with being 0 as the better outcome and 21 being the worse outcome.

  7. Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the determination of SARS-CoV-2 specific igG

    Time frame: At day 0, 8, 15, 22, 45 and 90.

    Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the determination of SARS-CoV-2 specific igG in plasma (Arbitrary Units, AU)

  8. Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the neutralization activity evaluation

    Time frame: At day 0, 8, 15, 22, 45 and 90.

    Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the analysis of reciprocal titers of neutralizing antibodies against SARS-CoV-2

  9. Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the T-Cell response

    Time frame: At day 0, 8, 15, 22, 45 and 90.

    Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the reduction of T-Cell response (%) from plasma samples

  10. Determination of residual SARS-CoV-2 particles (RNA) in plasma from subjects with PCC

    Time frame: At days 0, 8, 15, 22, 45, and 90

    Virological assessment to determine the residual SARS-CoV-2 RNA (copies/mL)

  11. Changes in microbiota associated with PE in subjects with PCC

    Time frame: At day 1, 8, 15, 22, 45 and 90

    Stool assessment to determine the residual SARS-CoV-2 RNA (copies/mL)

Sponsors and collaborators

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Other

Collaborators

  • Banc de Sang i Teixits
  • IrsiCaixa

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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