EUCTR2022-000641-33-ES进行中（未招募）1 期
Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study
Fundacio´ FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promocio´ de la Salut i La Cie`ncia0 个研究点目标入组 50 人开始时间: 2022年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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