A Phase I/II Randomized Double-blinded Placebo-controlled Clinical Trial to Determine Safety and Feasibility of Using an Acellular Sterile Filtered Amniotic Fluid as a Treatment for COVID-19 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- C-reactive Protein
研究概览
简要总结
The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.
详细描述
Past use of human amniotic products (i.e., membrane and fluid) has previously been FDA-approved as a human cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) under 21 CFR 1271 for tissue injury; and has been used to reduce inflammation and fibrosis in patients with a variety of ailments. Given this, the investigators hypothesize that intravenously (IV) administered processed sterile filtered amniotic fluid will reduce inflammation in COVID-19 patients, and improve secondary clinical outcomes. Specifically, the investigators hypothesize that patients who receive IV administered hAF will see a 50% reduction in mean C-reactive protein levels following treatment.
Data sharing: Trial results will be published in peer reviewed publications upon completion of analysis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS CoV-2 laboratory positive test, obtained within 14 days of enrollment
- •Hospitalized
- •COVID-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production)
- •Has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy
- •Patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study investigational product (IP)
- •Patients who are receiving standard of care therapies for COVID-19 that are not FDA approved are eligible for this study
- •Subjects must be able to consent to the study (i.e., Glasgow Coma Scale score of ≥14)
- •Patients are required to have controlled blood pressure of <160/96 and a pulse of <110.
排除标准
- •Patients on invasive mechanical ventilation (e.g., endotracheal intubation)
- •Chronic home oxygen utilization
- •Home or current use of immunosuppressive medications (including steroids)
- •Women who are pregnant, breastfeeding, or become pregnant during the study
- •Patients on non-invasive positive pressure ventilation
- •Patients on >12 liters per minute via non-rebreather (NRB) or >80% oxygen via high flow nasal cannula
- •Patients who, in the opinion of the PI, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation
- •Patients with a hemoglobin <9 mg/dL
- •Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD)
- •Patients with diagnosed New York Heart Association (NYHA) class 4 or 5 congestive heart failure
- •Patients with a left ventricular assist device (LVAD)
- •Patients with thromboembolic phenomena
- •Patients with Type 2 and above heart block
- •Patients with established positive bacterial blood cultures prior to enrollment
- •Patients with ongoing pericardial effusion or ascites
- •Patients with clinically significant arrhythmia
- •Patients with liver function tests (ALT or AST) >3x normal
- •Patients with untreated HIV infection
- •Patients diagnosed with end-stage organ disease
研究组 & 干预措施
Intervention
10ml intravenous hAF QD (once daily) for 5 consecutive days
干预措施: Human Amniotic Fluid (Biological)
Standard of Care
10 mL normal saline QD (once daily) for 5 days
结局指标
主要结局
C-reactive Protein
时间窗: Baseline through post-treatment (6 days)
Assess reduction of inflammation in COVID-19 patients, potentially leading to a decrease in the need for critical care. This will be assessed by measurement of C-reactive protein levels before and after the intervention. Units: mg/dL
次要结局
未报告次要终点
研究者
Craig Selzman
Principle Investigator
University of Utah