合成生物药物可利霉素(Carrimycin)治疗COVID-19:FDA已允许开展III期临床试验

2020-12-30 Allan MedSci原创

Carrimycin已成为世界上第一款用于重症COVID-19患者的合成生物药物,美国食品药品监督管理局(FDA)已允许开展Carrimycin治疗COVID-19的III期临床试验。

可利霉素(Carrimycin)已成为世界上第一款用于重症COVID-19患者的合成生物药物,美国食品药品监督管理局(FDA)已允许开展Carrimycin治疗COVID-19的III期临床试验。前期数据已经表明,Carrimycin可以有效治疗重症COVID-19患者,帮助他们在14天之内从严重症状中恢复过来。

FDA批准的国际多中心III期临床试验将于2021年1月开始,为期六个月。它将在美国、阿根廷、巴西、哥伦比亚、印度、墨西哥、秘鲁、菲律宾和乌克兰进行。但是,随着大流行的发生,可以调整地点。该试验将涉及300例患者,一半在实验组,另一半在对照组。

Carrimycin除具有抗菌作用外,还具有抗病毒、抗炎和抗纤维化作用。它最初旨在治疗由细菌引起的成人社区获得性感染。它是一款由沈阳同联集团在中国使用合成生物学技术开发的药物。

2020年初的实验室测试表明它具有很强的抗冠状病毒作用,可抑制细胞中SARS-CoV-2的复制。

原始出处:

https://www.firstwordpharma.com/node/1787346?tsid=4

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    2021-03-11 kalseyzl
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  5. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524911, encodeId=6d5715249114d, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Fri Jan 01 08:38:24 CST 2021, time=2021-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588070, encodeId=b69015880e0d9, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Fri Jan 01 08:38:24 CST 2021, time=2021-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594848, encodeId=5f5d1594848db, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Jan 01 08:38:24 CST 2021, time=2021-01-01, status=1, ipAttribution=)]
    2021-08-12 juliusluan78
  6. 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  7. 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    2021-01-01 guihongzh
  8. 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美FDA发布德美研发的新冠疫苗分析报告:符合紧急使用授权标准

美国食品和药物管理局(FDA)8日发布一份分析报告称,临床研究结果显示,德国生物新技术公司和美国辉瑞制药有限公司合作开发的新冠疫苗符合FDA规定的紧急使用授权的标准。

创新靶向药RET抑制剂Pralsetinib扩展适应症获美国FDA批准,用于治疗甲状腺癌

近日,美国食品药品监督管理局(FDA)加速批准了创新靶向药RET抑制剂普拉替尼(pralsetinib)的扩展适应症,用于治疗携带RET变异的甲状腺癌患者。这是肿瘤精准治疗领域的又一重要里程碑。

深度盘点:2020年FDA批准53款新药上市,肿瘤药占1/3

2020年的上半年,美国FDA的药物评估与研究中心(CEDR)已经批准了

FDA批准武田的ICLUSIG(ponatinib)治疗耐药或不耐药的慢性粒细胞白血病

慢性粒细胞性白血病(CML)占整体白血病患者的15%。这种白血病表现为人体骨髓中的主要粒细胞不受管制地增长,并在血液中积累而形成。

拓展阅读

J Clin Med:COVID-19住院患者血栓形成和出血风险评分与死亡率密切相关

本研究提示COVID-19血栓形成和出血风险评分高的患者死亡率更高。

Front Med:COVID-19住院患者Casirivimab/imdevimab失败预测评分的开发和验证

Casirivimab和imdevimab是两种非竞争性、高亲和力的人IgG1抗COVID-19单克隆抗体,它们特异性结合COVID-19病毒刺突糖蛋白的受体结合域,从而阻断病毒进入宿主细胞。

Biomedicines:2型糖尿病住院患者COVID-19的长期预后

在T2D合并COVID-19患者中,随访观察到住院死亡率、卒中和心血管住院率增加。

Cureus:2型糖尿病状态、糖尿病并发症严重程度指数评分及其与COVID-19严重程度的关系

与非糖尿病患者相比,我们样本中的糖尿病患者发生COVID-19不良临床结果和住院死亡率的几率更高。

Lancet Infect Dis:口服VV116用于治疗轻中度COVID-19成人患者的有效性和安全性评价

目前,治疗COVID-19的医疗需求仍未得到满足,新型抗病毒药物-VV116可用于治疗轻中度COVID-19成人患者,能够显著缩短临床症状持续时间,与其他药物较少发生药物间相互作用,且安全性良好。

论文解读|Yihua Wang教授团队新研究揭示了揭示COVID-19对肺癌治疗和研究的深远影响

该文章揭示了此次大流行对肺癌治疗、临床试验、研究活动的影响。