用恢复期血浆治疗重症和危重 COVID-19 肺炎
2021年7月30日 更新者：Centro Medico ABC
与具有匹配对照的历史队列相比，开放标签双臂非随机恢复期血浆治疗严重和危重肺炎 COVID-19 住院患者。
研究概览
详细说明
我们将进行一项开放标签的双臂非随机试验，将从血清学呈阳性的康复 COVID-19 患者捐赠的恢复期血浆提供给 ABC 医疗中心收治的重症和临床肺炎 COVID-19 患者。
研究类型
介入性
注册 (实际的)
6
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Mexico City、墨西哥、01120
- Centro Médico ABC
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
捐助者：
- 年龄：>18 岁且 <60 岁
- 体重：>60 公斤
- 确认之前感染过 SARS CoV-2
- SARS CoV-2 检测结果呈阴性
- SARS CoV2 阴性测试无症状 21 天
- 书面知情同意参加该临床试验，捐献血浆和储存标本以供将来测试。
- 阳性 COVID-19 IgG 抗体
- 男性捐献者，或未怀孕的女性捐献者，或已怀孕的女性捐献者 HLA 抗体检测呈阴性
- 符合墨西哥立法规定的所有常规自愿捐助者资格要求的个人。
患者/接受者：
- 年龄：>18 岁
- 因治疗 COVID-19 而入住 ABC 医疗中心设施
- 重症或危重 COVID-19 患者
- 患者或医疗保健代理人提供的知情同意书
排除标准：
患者/接受者：
1. 输血禁忌症（严重容量超负荷、血制品过敏史） 2. 任何其他未控制的感染 3. 弥散性血管内凝血病 4. 透析患者 5. 近期出血性中风患者 6. 严重缺血性心脏病
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学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：严重的 COVID-19 肺炎
严重感染 SARS-CoV 2 的住院患者将接受抗 SARS-CoV 2 恢复期血浆
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将恢复期血浆用于 COVID-19，该捐献者是从先前记录的 SARS-CoV 2 感染 IgG 抗体到住院的 COVID-19 重症病例。
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实验性的：危重 COVID-19 肺炎
患有 SARS-CoV 2 严重感染的住院患者将接受抗 SARS-CoV 2 恢复期血浆
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将恢复期血浆用于 COVID-19，该捐献者之前记录有 SARS-CoV 2 感染 IgG 抗体，用于住院的 COVID-19 危重病例。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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重症肺炎的发病率
大体时间：恢复期血浆给药后 14 天
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进入关键阶段
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恢复期血浆给药后 14 天
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重症肺炎患者的死亡率
大体时间：恢复期血浆给药后 28 天
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死亡
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恢复期血浆给药后 28 天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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机械通气的发生率
大体时间：恢复期血浆治疗后 14 天
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需要机械通气的时间
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恢复期血浆治疗后 14 天
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机械通气天数
大体时间：恢复期血浆治疗后 28 天
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所需机械通气时间
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恢复期血浆治疗后 28 天
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Francisco Moreno, MD、ABC Medical Center Internal Medicine Department. Mexico City, Mexico
- 首席研究员：Irma Hoyo, MD PHD、ABC Medical Center Internal Medicine Department. Mexico City, Mexico
- 首席研究员：Benjamín Valente, MD MSc DTMH、ABC Medical Center Internal Medicine Department. Mexico City, Mexico
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
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- Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.
- Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.
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- Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.
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- Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
- Bloch EM, Shoham S, Casadevall A, Sachais BS, Shaz B, Winters JL, van Buskirk C, Grossman BJ, Joyner M, Henderson JP, Pekosz A, Lau B, Wesolowski A, Katz L, Shan H, Auwaerter PG, Thomas D, Sullivan DJ, Paneth N, Gehrie E, Spitalnik S, Hod EA, Pollack L, Nicholson WT, Pirofski LA, Bailey JA, Tobian AA. Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest. 2020 Jun 1;130(6):2757-2765. doi: 10.1172/JCI138745.
- Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
- Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
- Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. Erratum In: Nature. 2020 Dec;588(7836):E6.
- Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
- van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
- Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3. Erratum In: Nature. 2020 Apr;580(7803):E7.
- Burke RM, Midgley CM, Dratch A, Fenstersheib M, Haupt T, Holshue M, Ghinai I, Jarashow MC, Lo J, McPherson TD, Rudman S, Scott S, Hall AJ, Fry AM, Rolfes MA. Active Monitoring of Persons Exposed to Patients with Confirmed COVID-19 - United States, January-February 2020. MMWR Morb Mortal Wkly Rep. 2020 Mar 6;69(9):245-246. doi: 10.15585/mmwr.mm6909e1.
- Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.
- Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.
- Liu K, Fang YY, Deng Y, Liu W, Wang MF, Ma JP, Xiao W, Wang YN, Zhong MH, Li CH, Li GC, Liu HG. Clinical characteristics of novel coronavirus cases in tertiary hospitals in Hubei Province. Chin Med J (Engl). 2020 May 5;133(9):1025-1031. doi: 10.1097/CM9.0000000000000744.
- Patel A, Jernigan DB; 2019-nCoV CDC Response Team. Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak - United States, December 31, 2019-February 4, 2020. MMWR Morb Mortal Wkly Rep. 2020 Feb 7;69(5):140-146. doi: 10.15585/mmwr.mm6905e1. Erratum In: MMWR Morb Mortal Wkly Rep. 2020 Feb 14;69(6):173.
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- Kraft CS, Hewlett AL, Koepsell S, Winkler AM, Kratochvil CJ, Larson L, Varkey JB, Mehta AK, Lyon GM 3rd, Friedman-Moraco RJ, Marconi VC, Hill CE, Sullivan JN, Johnson DW, Lisco SJ, Mulligan MJ, Uyeki TM, McElroy AK, Sealy T, Campbell S, Spiropoulou C, Stroher U, Crozier I, Sacra R, Connor MJ Jr, Sueblinvong V, Franch HA, Smith PW, Ribner BS; Nebraska Biocontainment Unit and the Emory Serious Communicable Diseases Unit. The Use of TKM-100802 and Convalescent Plasma in 2 Patients With Ebola Virus Disease in the United States. Clin Infect Dis. 2015 Aug 15;61(4):496-502. doi: 10.1093/cid/civ334. Epub 2015 Apr 22.
- Florescu DF, Kalil AC, Hewlett AL, Schuh AJ, Stroher U, Uyeki TM, Smith PW. Administration of Brincidofovir and Convalescent Plasma in a Patient With Ebola Virus Disease. Clin Infect Dis. 2015 Sep 15;61(6):969-73. doi: 10.1093/cid/civ395. Epub 2015 May 19.
- Zhou B, Zhong N, Guan Y. Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med. 2007 Oct 4;357(14):1450-1. doi: 10.1056/NEJMc070359. No abstract available.
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有用的网址
- WHO Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020 [Internet]. [cited 2020 Mar 23].
- Johns Hopkins Coronavirus Resource Center [Internet]. Johns Hopkins Coronavirus Resource Center. [cited 2020 Mar 23].
- Situation update worldwide, as of 22 March 2020 [Internet]. European Centre for Disease Prevention and Control. [cited 2020 Mar 23]
- Novel Coronavirus (2019-nCoV) situation reports [Internet]. [cited 2020 Mar 23].
- CDC. Coronavirus Disease 2019 (COVID-19) Situation Summary [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Mar 23].
- who-china-joint-mission-on-covid-19-final-report.pdf [Internet]. [cited 2020 Mar 23].
- CDC. Coronavirus Disease 2019 (COVID-19) [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Apr 7].
- National COVID-19 Convalescent Plasma Project [Internet]. [cited 2020 Apr 8].
- Convalescent Plasma COVID-19 (Coronavirus) Treatment - Mayo Clinic [Internet]. [cited 2020 Apr 8]. Available from:
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年8月8日
初级完成 (实际的)
2021年1月29日
研究完成 (实际的)
2021年1月29日
研究注册日期
首次提交
2020年6月12日
首先提交符合 QC 标准的
2020年6月12日
首次发布 (实际的)
2020年6月16日
研究记录更新
最后更新发布 (实际的)
2021年8月2日
上次提交的符合 QC 标准的更新
2021年7月30日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.