Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS)
时间窗: 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
Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange (placebo)
时间窗: 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
Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS)
时间窗: 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
次要结局
- Assess the ability of PE to improve PCC symptoms(At days 0, 8, 15, 22, 45 and 90)
- Assess the impact of PE on quality of life in subjects with PCC(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(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(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(At days 0, 22 and 90)
- Assess the impact of PE on neurocognitive symptoms in subjects with PCC using MEF-30 questionnaire(At days 0, 22 and 90)
- Assess the impact of PE on neurocognitive symptoms in subjects with PCC using HADs questionnaire(At days 0, 22 and 90)
- Changes in cellular anti-SARS-CoV-2 immunity associated with PE in subjects with PCC by the neutralization activity evaluation(At day 0, 8, 15, 22, 45 and 90.)
- Changes in microbiota associated with PE in subjects with PCC(At day 1, 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(At day 0, 8, 15, 22, 45 and 90.)
- Determination of residual SARS-CoV-2 particles (RNA) in plasma from subjects with PCC(At days 0, 8, 15, 22, 45, and 90)