Safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19: protocol for a randomised, double-blinded, placebo-controlled clinical trial.
Safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19: protocol for a randomised, double-blinded, placebo-controlled clinical trial.
复制标题
DOI：
10.1136/bmjopen-2020-045162
复制
发表时间：
2021-02-11
期刊：
影响因子：
2.9
通讯作者：
Selzman CH
中科院分区：
文献类型：
--
作者：
Tonna JE;Pierce J;Hatton N;Lewis G;Phillips JD;Messina A;Skidmore CR;Taylor K;Selzman CH
在多个实验模型中，人羊水（hAF）已显示出减轻炎症的作用。hAF此前已被美国食品和药物管理局（FDA）批准作为人体细胞和组织产品，用于人体给药，用于治疗组织损伤，并安全用于数千名患者，作为各种疾病的治疗方法。鉴于在COVID-19患者中观察到深刻的炎症反应，以及成功完成10例静脉注射hAF的中试研究，我们提出了一项更大规模的静脉注射hAF治疗COVID-19临床试验的试验设计。本文介绍了一项I/II期随机、双盲、安慰剂对照临床试验的方法，以确定使用脱细胞无菌过滤羊水治疗COVID-19患者的安全性和可行性。主要结果是c反应蛋白的变化。次要结局包括安全性、生物标志物炎症水平和30天的临床相关结局，包括死亡率、无呼吸机天数以及住院和重症监护病房的住院时间。收集患者报告的与健康相关的生活质量的探索性结果。将招募实验室确诊的COVID-19住院患者。该研究已获得犹他大学机构审查委员会（IRB_0013292）批准，美国FDA在研究新药（No 23369）下批准，并在ClinicalTrials.gov上注册。研究结果将通过同行评议的出版物和会议报告进行传播。NCT04497389;Pre-results。
Human amniotic fluid (hAF) has been shown to reduce inflammation in multiple experimental models. hAF has previously been approved by the US Food and Drug Administration (FDA) as a human cellular and tissue product for tissue injury for human administration, and used safely in thousands of patients as a therapeutic treatment for diverse conditions. Given the profound inflammatory response observed in patients with COVID-19, and the successful completion of 10-patient pilot study of intravenous hAF, we present a trial design for a larger clinical trial of intravenous hAF for the treatment of COVID-19. This paper describes the methodology of a phase I/II randomised, double-blinded, placebo-controlled clinical trial to determine the safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19. Primary outcome will be the change in C-reactive protein. Secondary outcomes include safety, biomarker inflammatory levels and clinically relevant outcomes at 30 days, including mortality, ventilator-free days and hospital and intensive care unit length of stay. Exploratory outcomes of health-related quality-of-life patient-reported outcomes will be collected. Hospitalised patients with laboratory-confirmed COVID-19 will be recruited. This study was approved by the University of Utah Institutional Review Board (IRB_0013292), approved by the US FDA under Investigational New Drug (No 23369) and is registered on ClinicalTrials.gov. Results will be disseminated via peer-reviewed publications and conference presentations. NCT04497389; Pre-results.
登录
查看更多内容
影响因子：
1.5
作者：
Pierce, Jan;Jacobson, Pam;Reems, Jo-Anna
通讯作者：
Reems, Jo-Anna
DOI：
10.1016/j.jtcvs.2015.10.015
发表时间：
2016-03-01
影响因子：
6
作者：
Sirch, Joachim;Ledwon, Miroslaw;Fischlein, Theodor
通讯作者：
Fischlein, Theodor
影响因子：
3.1
作者：
Koob TJ;Rennert R;Zabek N;Massee M;Lim JJ;Temenoff JS;Li WW;Gurtner G
通讯作者：
Gurtner G
影响因子：
1.5
作者：
Burman, Sanghamitra;Tejwani, Sushma;Sangwan, Virender S.
通讯作者：
Sangwan, Virender S.
影响因子：
1.5
作者：
Kim, Hwi Gon;Choi, Ook Hwan
通讯作者：
Choi, Ook Hwan