Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19

  • Ling Li
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • Wei Zhang
    Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.
  • Yu Hu
    Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • Xunliang Tong
    Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Respiratory quality control center, National Center of Gerontology, Beijing, China
  • Shangen Zheng
    Department of Transfusion, General Hospital of Central Theater Command of PLA, Wuhan, China
  • Juntao Yang
    State Key Laboratory of Medical Molecular Biology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union, Beijing, China
  • Yujie Kong
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • Lili Ren
    NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China
  • Qing Wei
    Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • Heng Mei
    Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • Caiying Hu
    Wuhan Red Cross Hospital, Wuhan, China
  • Cuihua Tao
    Department of Blood Transfusion, Wuhan Asia Heart Hospital, Wuhan, China
  • Ru Yang
    Wuhan Blood Center, Wuhan, China
  • Jue Wang
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • Yongpei Yu
    Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China
  • Yong Guo
    Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China
  • Xiaoxiong Wu
    Department of Emergency, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • Zhihua Xu
    Wuhan Red Cross Hospital, Wuhan, China
  • Li Zeng
    Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.
  • Nian Xiong
    Wuhan Red Cross Hospital, Wuhan, China
  • Lifeng Chen
    Wuhan Pulmonary Hospital, Wuhan, China
  • Juan Wang
    Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • Ning Man
    Department of Respiratory Medicine, Wuhan Asia General Hospital, Wuhan, China
  • Yu Liu
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • Haixia Xu
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • E. Deng
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • Xuejun Zhang
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • Chenyue Li
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China
  • Conghui Wang
    NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China
  • Shisheng Su
    Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China
  • Linqi Zhang
    Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, and Beijing Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China
  • Jianwei Wang
    NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China
  • Yanyun Wu
    Department of Pathology, University of Miami, Miami, Florida
  • Zhong Liu
    Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China

書誌事項

タイトル別名
  • A Randomized Clinical Trial

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説明

Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P  .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.Chinese Clinical Trial Registry: ChiCTR2000029757.

収録刊行物

  • JAMA

    JAMA 324 (5), 460-, 2020-08-04

    American Medical Association (AMA)

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