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约翰霍普金斯大学获得3500万美元联邦资金用于新冠病毒恢复期血浆疗法试验

  • 责任编辑:siyu.zhang
  • 来源:互联网
  • 时间:2020-07-31 10:37:22

  新冠病毒令美国民众十分担忧,而对新冠病毒患者来说更艰难的事恢复健康,近日恢复期血浆疗法引发美国关注,约翰霍普金斯大学将对其进行试验研究。

  约翰·霍普金斯获得3500万美元的联邦资金,用于新冠病毒血浆试验

  研究人员将在两个全国性试验中测试恢复期血浆疗法,以确定其对新冠病毒患者的治疗效果

  作者:海伦·琼斯/出版时间:12小时前

  约翰·霍普金斯大学的研究人员从美国国防部获得3500万美元的资助,用于两项全国性临床试验,以测试恢复期血浆门诊治疗的有效性,该疗法可能有助于COVID-19患者的免疫系统对抗病毒。

  这项共1100人的随机双盲试验将在包括纳瓦霍族在内的美国各医疗中心的20多个门诊诊所进行,将帮助研究人员确定恢复期血浆疗法(一种来自COVID-19幸存者的含有抗体的血液制品的输血)是否有效用于治疗COVID-19疾病的早期患者,或预防在家或工作中接触病毒的高危人群的感染。

  目前,还没有FDA批准的疫苗来防止感染引起COVID-19的SARS-CoV-2病毒,也没有批准对这种疾病的早期治疗。也没有门诊治疗来防止住院或死亡。

  “这是一个研究人员和机构之间进行重要研究的巨大协同作用的故事,这些研究将告诉我们的国家和世界血浆在预防COVID-19和治疗早期疾病方面的有效性,”彭博社杰出教授Arturo Casadevall说,他是彭博社公共卫生学院的联合任命者还有医学院。为了启动这项临床试验,卡萨德瓦尔和他的同事们在约翰·霍普金斯大学和美国各地参与的医疗中心召集了广泛的研究人员合作。

  这些试验的领导者包括卡萨德瓦尔和他的同事,医学院的医学副教授Shmuel Shoham,彭博公共卫生学院分子微生物学和免疫学教授David Sullivan,以及Daniel Hanley,医学院临床与转化研究所多站点临床试验主任。

  苏利文说:“血浆疗法可能最有可能为接触COVID-19的高危人群提供即时免疫,并尽早治疗COVID-19,以防止住院或死亡。”为了明确证明这一点,我们需要一项严格的随机临床研究来评估它。”

  这项预防试验将包括500名在家中或在工作中接触过COVID-19的人。这项配对试验将有另外600名参与者患有早期COVID-19疾病,这意味着他们在出现第一次症状的8天内,但病情还不足以住院治疗。所有参加者都将年满18岁。研究人员的目标是在2020年秋初完成试验参与者的招募。

  恢复期血浆疗法包括从病毒康复者身上输入一部分称为血浆的血液。当血浆从血液中的红、白细胞和血小板中分离出来时,它是一种黄色的液体,其中含有一种叫做抗体的蛋白质,它会附着在诸如病毒之类的外来物质上,或者标记它们被免疫系统破坏,或者破坏病毒繁殖和生长的能力。

  一个多世纪以来,医生们在医院里使用这种疗法治疗严重疾病,通常是在1918年流感大流行和2003年最近爆发的严重急性呼吸综合征(severe acute respiratory syndrome)等流行病期间。过去的实验室实验表明,这种疗法能中和许多病毒。然而,这种疗法通常用于危机的混乱阶段,而没有大规模临床试验的严格性。

  据研究人员说,很少有临床数据证明在门诊使用这种疗法的有效性。目前,只有住院患者可以获得任何类型的COVID-19治疗。

  “由于从康复病人身上获得的血浆广泛可用,它可能是一种快速、低成本的治疗方法,在流行病的早期阶段具有重要价值。需要一个随机试验来清楚地证明这些历史和实验室证明的益处,”汉利说。

  在这些试验中使用的血浆是从许多组织收集的,包括纽约血液中心和美国红十字会。一个捐献者可以为三个人提供血浆。试验参与者将在门诊接受一次静脉输注血浆,这通常需要一个小时。

  作为试验的一部分,患有COVID-19的受试者将被监测四周,以确定疾病的病程及其严重程度。暴露于病毒中的参与者将在四周内评估其是否感染COVID-19,包括症状检查和实验室检测病毒和抗体。研究人员将在输注恢复期血浆三个月后检查两组的长期免疫功能。

  Shoham说,通过这些试验,研究人员希望了解血浆是否能够防止感染或将其压扁他说:“这也有生物学意义,”他补充说,血浆疗法可以扩大病毒性疾病的治疗选择我们正在恢复一种对抗病原体的旧方法,它可能对疟疾等其他病毒或寄生虫有用。”

  约翰·霍普金斯关于恢复期血浆疗法的研究先前由彭博慈善机构捐赠的300万美元和马里兰州的100万美元资助。约翰·霍普金斯还获得了美国国立卫生研究院(National Institutes of Health)的国家过敏和传染病研究所(National Institute of Allergency and Infectional Diseases)的100万美元奖金。此外,研究人员还利用美国国家转化科学中心试验创新网络和密歇根州立大学的国家COVID-19恢复期血浆项目来培养参与中心对该试验的兴趣。

  负责化学、生物、放射和核防御的联合项目副执行官杰森·鲁斯说:“我们已经看到,恢复期血浆可以使遭受COVID-19最严重影响的患者受益。JPEO-CBRND很高兴能与约翰·霍普金斯大学合作,以确定同一种血浆是否可以帮助我们的联合部队免受COVID-19的侵袭,无论是完全预防感染,还是大幅度降低症状。这些有益的结果将有助于我们确保军人和妇女保持健康,以便他们能够完成任务。”

  支持该项目的其他关键教师包括约翰霍普金斯大学彭博公共卫生学院的病毒学家安迪·佩科兹和萨布拉·克莱恩,医学院的输血医学专家埃文·布洛赫和亚伦·托宾。

  在健康中发布

  标记arturo casadevall,冠状病毒,covid-19

  附上原文,以供参考,拒绝转载,侵权必删:

  JOHNS HOPKINS RECEIVES $35M IN FEDERAL FUNDING FOR COVID-19 BLOOD PLASMA TRIALS

  Researchers will test convalescent blood plasma therapy in two nationwide trials to determine its effectiveness in treating COVID-19 patients

  By Helen Jones / Published 12 hours ago

  Johns Hopkins researchers have received $35 million in funding from the U.S. Department of Defense for two nationwide clinical trials to test the effectiveness of a convalescent blood plasma outpatient treatment that may help COVID-19 patients' immune systems fight the virus.

  The randomized double blind trials totaling 1,100 people will be conducted at over 20 ambulatory clinics in medical centers across the U.S., including the Navajo Nation, and will help researchers determine whether convalescent blood plasma therapy—a transfusion of a blood product from COVID-19 survivors that contains antibodies—can effectively be used to treat people in the early stage of COVID-19 illness or prevent the infection in those at high risk of exposure to the virus at their home or jobs.

  Currently, there are no FDA-approved vaccines to prevent infection with the SARS-CoV-2 virus, which causes COVID-19, nor approved treatments for the illness in its earliest stage. There are also no outpatient therapies to prevent hospitalization or death.

  "This is a story of great synergy between researchers and institutions to carry out important studies that will inform our nation and the world on how effective plasma can be to prevent COVID-19 and to treat early disease," says Arturo Casadevall, a Bloomberg Distinguished Professor who holds joint appointments in Bloomberg School of Public Health and School of Medicine. To initiate the clinical trial, Casadevall and his colleagues assembled a broad collaboration of investigators at Johns Hopkins and at participating medical centers across the U.S.

  Leaders of the trials include Casadevall and his colleagues Shmuel Shoham, associate professor of medicine at School of Medicine, David Sullivan, professor of molecular microbiology and immunology at the Bloomberg School of Public Health, and Daniel Hanley, director for multisite clinical trials in the Institute for Clinical and Translational Research at the School of Medicine.

  "Blood plasma therapy may have the most potential in providing immediate immunity to people at high risk of COVID-19 exposure and treating COVID-19 early to prevent hospitalization or death," says Sullivan. "For definitive proof of this, we need a rigorous randomized clinical study to evaluate it."

  The prevention trial will include 500 people who have been exposed to COVID-19 in their home or at work as health care providers. The companion trial will have another 600 participants who have early COVID-19 disease, meaning they are within eight days of their first symptoms but are not sick enough to be in a hospital. All participants will be over age 18. The researchers aim to complete recruitment of participants to the trial in early fall 2020.

  Convalescent blood plasma therapy involves transfusing a portion of blood called plasma from people who have recovered from the virus. When separated from red and white blood cells and platelets in the blood, plasma is the yellow-tinged liquid that includes proteins called antibodies, which glom on to foreign substances such as viruses and either mark them for destruction by the immune system or disrupt a virus' ability to multiply and grow.

  Physicians have used the treatment for severe diseases in hospitals for more than a century, often during epidemics such as the influenza pandemic of 1918 and the more recent outbreak of severe acute respiratory syndrome in 2003. Laboratory experiments in the past have shown that the therapy neutralizes many viruses. However, the treatment is often used in the chaotic phases of a crisis without the rigors of a large clinical trial.

  There is very little clinical data proving the effectiveness of using the therapy in outpatient clinics, according to the researchers. Currently, only hospitalized patients have access to any type of therapy for COVID-19.

  "Because plasma from recovering patients is widely available, it may be a rapid low-cost treatment of major value in early stages of epidemics. A randomized trial is needed to clearly demonstrate these historical and laboratory proven benefits," says Hanley.

  The blood plasma used in these trials is being collected from many organizations, including the New York Blood Center and the American Red Cross. One donor can provide plasma for up to three people. Trial participants will receive one IV infusion of the plasma at an outpatient facility, which usually takes about an hour.

  As part of the trials, participants with COVID-19 will be monitored over four weeks to determine the course of the disease and its severity. Participants who have been exposed to the virus will be evaluated over four weeks for development of COVID-19 infection, including symptom checks and laboratory testing for the virus and antibodies. The researchers will examine the long-term immunity of both groups at three months after infusion with convalescent plasma.

  From the trials, Shoham says, the researchers hope to learn if blood plasma can prevent infection or squash it where it begins. "There are also biological implications," he says, adding that blood plasma therapy could expand treatment options for viral diseases. "We're reviving an old approach to fight pathogens, and it may be useful for other viruses or parasites such as malaria."

  Johns Hopkins research into convalescent blood plasma therapy was previously funded by $3 million from a Bloomberg Philanthropies gift and $1 million from the state of Maryland. Johns Hopkins also received a $1 million award supplement from the National Institutes of Health's National Institute of Allergy and Infectious Diseases. Additionally, the researchers used the National Center for Advancing Translational Sciences Trial Innovation Network and the National COVID-19 Convalescent Plasma Project at Michigan State University to develop interest in the trial among participating centers.

  Jason Roos, deputy joint program executive officer for chemical, biological, radiological and nuclear defense, says, "We've seen that convalescent plasma can benefit patients suffering from some of the worst effects of COVID-19. The JPEO-CBRND is excited to be working with Johns Hopkins University to determine whether that same plasma could help protect our Joint Forces from COVID-19, either by preventing infection altogether or drastically reducing their symptoms. Those types of beneficial outcomes would help us make sure our servicemen and women stay healthy so they can complete their mission."

  Other key faculty supporting this project include virologists Andy Pekosz and Sabra Klein of the Johns Hopkins Bloomberg School of Public Health and transfusion medicine experts Evan Bloch and Aaron Tobian of the School of Medicine.

  Posted in Health

  Tagged arturo casadevall, coronavirus, covid-19

  Source of articles:https://hub.jhu.edu/

  Author:Helen Jones

  以上就是新冠病毒的最新疗法介绍了,希望约翰霍普金斯大学专家能够帮助到新冠病毒患者,如果你对恢复期血浆疗法还想了解更多,请关注天道海外疫情栏目。


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