Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study - Trial NCT05445674
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.
Study Focus
Sponsor & Location
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Timeline & Enrollment
Phase 2
Sep 01, 2022
Jul 01, 2023
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
Data Source
ClinicalTrials.gov
NCT05445674
Non-Device Trial