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

Phase 1

Conditions: Post-Acute-Covid-19 Syndrome
MedDRA version: 24.0Level: PTClassification code 10085503Term: Post-acute COVID-19 syndromeSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2022-000641-33-ES

Lead Sponsor: Fundacio´ FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promocio´ de la Salut i La Cie`ncia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>2.Assess the ability of PE to improve PCC symptoms. <br>3.Assess the impact of PE on quality of life in subjects with PCC.<br>4.Assess changes in inflammation, autoimmunity, humoral and cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC<br>5.Assess the presence of viral particles in plasma from subjects with PCC<br>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. <br>;Primary end point(s): The proportion of adverse events (AEs) through day 90, considering: <br><br>All AEs<br>Grade 3 and 4 AEs <br>AEs leading to study discontinuation<br>;Timepoint(s) of evaluation of this end point: at day 90

Secondary Outcome Measures