NCT04592705Unknown1 期
Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalized Patients
Larkin Community Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年9月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Time to clinical status downgrade or discharge.
研究概览
简要总结
Given the current lack of an effective drug or therapy, a clinical trial to better understand the safety and efficacy of therapeutic plasma exchange (TPE) in COVID-19 patients is urgently needed. The goal of this trial is to study the efficacy and safety of TPE therapy in subjects with moderate to severe COVID-19 by determining the morbidity and mortality after TPE therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate-severe COVID-19 infection including early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)
- •Able to provide Informed Consent signed by the subject or by the subject's legal or healthcare proxy.
- •Admitted to the participating facilities as listed above (Larkin South Miami Hospital, Larkin Palm Springs Hospital).
- •Subjects between 18 and 69 years of age.
- •If female, subjects that have a negative result in a quantitative b-HCG blood test if they are within reproductive age.
- •A positive COVID-19 test via nasopharyngeal swab RT-PCR.
- •Agree to not participate in another clinical trial during the study period.
排除标准
- •Under 18 years of age or older than 69 years of age.
- •Severe disease, defined as:
- •i. dyspnea ii. respiratory frequency ≥ 30/min iii. blood oxygen saturation ≤ 93% iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v. lung infiltrates > 50% within 24 to 48 hours;
- •Life-threatening disease, defined as:
- •i. respiratory failure ii. septic shock, and/or iii. multiple organ dysfunction or failure
- •Unable to provide informed consent or decline to consent.
- •Sequential Organ Failure Assessment (SOFA) score of 12 or above.
- •Hemodynamic instability, sepsis, or other conditions causing inability to tolerate fluid shifts
- •Inability to tolerate central line placement
- •Allergy to FFP or albumin
- •Severe hypocalcemia
- •Patients with heparin allergies should not receive heparin as an anticoagulant during plasmapheresis
- •Patients taking angiotensin-converting enzyme (ACE) inhibitors are advised to stop taking the medication for at least 24 hours before starting plasmapheresis
- •Active or recent bleeding (unless controlled for >48 hours).
- •Thrombocytopenia (≤25,000/L).
- •Advanced cirrhosis with a history of esophageal varices.
- •Chronic kidney disease requiring hemodialysis.
- •Active solid or non-solid malignancy or Lymphoma within the last 2 years.
- •Heart failure (NYHA class III or IV).
- •HIV infection (AIDS criteria), a history of immunodeficiency, or subject is currently receiving immunosuppressive therapy.
- •Women of childbearing age who are pregnant or intend to become pregnant during the study period.
- •Known history of chromosomal or genetic abnormalities.
- •History of hypersensitivity or any kind of adverse reaction to blood products.
- •Contraindication to transfusion of blood products, or refusal due to religious/personal reasons.
- •Any kind of drug or alcohol dependence that would interfere with adherence to the study requirements.
- •Already part of this trial, recruited at a different hospital.
结局指标
主要结局
Time to clinical status downgrade or discharge.
时间窗: 60 days
Clinical improvement will be defined as a point reduction in subjects' clinical status on the 8-point WHO ordinal scale for clinical improvement or discharge from the hospital, whichever comes first.
次要结局
未报告次要终点
研究者
Michael Talalaev, M.D., D.O.
Principal Investigator
Larkin Community Hospital
研究点 (2)
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