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NCT05445674

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

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 2·ClinicalTrials.gov·combination productNot yet recruiting
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Study focus
Disease/Condition
Post-COVID19 Condition
Drug/Device/Intervention
Plasma Exchange Procedure
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Location
Badalona, Spain
Timeline & enrollment
Phase
Phase 2
Start date
Sep 01, 2022
End date
Jul 01, 2023
Enrollment
50 participants
Primary outcome

Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange (placebo),Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS),Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS)

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.

ICD-10 classifications
COVID-19, virus identifiedCOVID-19, virus not identifiedHIV disease resulting in other specified conditionsObservation for suspected disease or condition, unspecifiedAmenorrhoea, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05445674
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05445674 through Pure Global AI's free database. This Phase 2 trial is sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia and is currently Not yet recruiting. The study focuses on Post-COVID19 Condition. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.