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| Name | Class |
|---|---|
| IrsiCaixa | OTHER |
| Banc de Sang i Teixits | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the ability of PE to improve PCC symptoms | Can Ruti PCC symptoms scale questionnare by days 0, 8, 15, 22, 45 and 90 | At days 0, 8, 15, 22, 45 and 90 |
| Assess the impact of PE on quality of life in subjects with PCC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lourdes Mateu Pruñonosa, PhD, MD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39994269 | Derived | 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. |
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Prospective, randomized (1:1), double-blind, placebo-controlled study
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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
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| 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 |
|
Quality of life questionnaires: EuroQol-5D questionnaire being 5 the better outcome and 15 the worse outcome.
| 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 | Quality of life questionnaires: MOS-HIV questionnaire being 4 the better outcome and 1 the worse outcome. | 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 | The neurocognitive evaluation assessed by the NeuScreen fluency test (Seconds) | At days 0, 22 and 90 |
| Assess the impact of PE on neurocognitive symptoms in subjects with PCC using MEF-30 questionnaire | The neurocognitive evaluation assessed by the MEF-30 questionnaire, with being 0 the better outcome and 120 being the worse outcome. | At days 0, 22 and 90 |
| Assess the impact of PE on neurocognitive symptoms in subjects with PCC using HADs questionnaire | The neurocognitive evaluation assessed by the HADs questionnaire, with being 0 as the better outcome and 21 being the worse outcome. | At days 0, 22 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 | 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) | 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 neutralization activity evaluation | 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 | 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 T-Cell response | 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 | At day 0, 8, 15, 22, 45 and 90. |
| Determination of residual SARS-CoV-2 particles (RNA) in plasma from subjects with PCC | Virological assessment to determine the residual SARS-CoV-2 RNA (copies/mL) | At days 0, 8, 15, 22, 45, and 90 |
| Changes in microbiota associated with PE in subjects with PCC | Stool assessment to determine the residual SARS-CoV-2 RNA (copies/mL) | At day 1, 8, 15, 22, 45 and 90 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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