Extracorporeal Photopheresis as a Possible Therapeutic Approach to Adults With Severe and Critical COVID-19 Non-responsive to Remdesivir, Dexamethasone and Pharmacological Immunomodulation: an Investigational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Clinical outcomes
研究概览
简要总结
Optimal approach for adult patients hospitalized with severe and critical COVID-19 non-responsive to antiviral and immunomodulatory drugs is not well established. The study aim is to evaluate feasibility and safety of extracorporeal photopheresis (ECP) in this setting.
详细描述
A prospective, single-center investigational study is olanned to be performed at a tertiary referral center for COVID-19. Patients with COVID-19 are screened, and severe or critical COVID-19 cases fulfilling pre-defined clinical and biochemical criteria of non-response for >5 days despite remdesivir, dexamethasone and immunomodulation (tocilizumab, baricitinib, ruxolitinib) are consecutively enrolled. After inclusion, two ECP sessions on two consecutive days per week for 2 weeks are applied. Patients are followed up per protocol from study inclusion, and clinical, virological and radiological outcomes are assessed at end-of-treatment (EOT)+28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Hospitalized adult (≥18 years at diagnosis) patients with diagnosed COVID-19 of any illness duration are eligible, and screened for inclusion during daily on-site investigator visits. Patients are consecutively enrolled.
- •Inclusion criteria:
- •severe or critical COVID-19,
- •clinical and biochemical non-response for >5 consecutive days, despite remdesivir, dexamethasone and immunomodulatory therapies (tocilizumab, baricitinib or ruxolitinib), with or without COVID-19 reconvalescent plasmatherapy, in absence of other causes.
排除标准
- •pregnancy or breastfeeding,
- •allergy or contraindications to 8-methoxypsoralen,
- •pre-COVID-19 ECP,
- •written informed consent was not obtainable.
- •Clinical non-response is defined when ≥2 of the following are met, compared to baseline:
- •persistent fever (non-contact tympanal measurement of >38.0°C) for ≥48 hours, despite antipyretics,
- •persistent or failing COVID-19 severity, according to World Health Organization criteria, by ≥1 stratum after ≥48 hours,
- •persistent or failing partial arterial oxygen tension (PaO2) / inspired oxygen fraction (FiO2), by ≥10% after ≥48 hours, despite respiratory support,
- •radiological progression by infiltrate extension on chest computed tomography (CT), by ≥10% after ≥48 hours,
- •novel requirement of invasive mechanical ventilation, as deemed necessary by an intensive care unit (ICU) team.
- •Biochemical non-response is defined when ≥2 of the following analytes show persistent or increasing levels by ≥20% after ≥48 hours, compared to baseline:
- •serum lactate dehydrogenase (LDH),
- •serum C-reactive protein (CRP),
- •serum ferritin
- •plasma interleukin-6 (IL-6),
研究组 & 干预措施
Extracorporeal photopheresis arm
Patients will receive extracorporeal photopheresis on this arm, in conjucntion to standard COVID-19 treatments (remdesivir, dexamethasone, IL-6- and/or JAK-inhibition).
干预措施: Extracorporeal photopheresis (Procedure)
结局指标
主要结局
Clinical outcomes
时间窗: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Clinical outcomes are all-cause death, invasive mechanical ventilation and ICU admittance requirement.
Virological outcomes
时间窗: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Virological outcomes are respiratory and blood SARS-CoV-2 RT-PCR positivity.
Radiological outcomes
时间窗: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Radiological outcomes are radiological progression/regression or fixed infiltration on chest CT scan.
次要结局
未报告次要终点
研究者
Bálint Gergely Szabó
Principal Investigator
Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases