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The feasibility of convalescent plasma therapy in severe COVID-19 patients: a pilot study
Kai Duan; Bende Liu; Cesheng Li; Huajun Zhang; Ting Yu; Jieming Qu; Min Zhou; Li Chen; Shengli Meng; Yong Hu; Cheng Peng; Mingchao Yuan; Jinyan Huang; Zejun Wang; Jianhong Yu; Xiaoxiao Gao; Dan Wang; Xiaoqi Yu; Li Li; Jiayou Zhang; Xiao Wu; Bei Li; Yanping Yu; Wei Chen; Yan Peng; Yeqin Hu; Lianzhen Lin; Xuefei Liu; Shihe Huang; Zhijun Zhou; Lianghao Zhang; Yue Wang; Zhi Zhang; Kun Deng; Zhiwu Xia; Qin Gong; Wei Zhang; Xiaobei Zheng; Ying Liu; Huichuan Yang; Dongbo Zhou; Ding Yu; Jifeng Hou; Zhengli Shi; Saijuan Chen; Zhu Chen; Xin-xin Zhang; Xiaoming Yang.
Afiliação
  • Kai Duan; 1.China National Biotec Group Company Limited, China;2.National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Prod
  • Bende Liu; First People Hospital of Jiangxia District, Wuhan, China
  • Cesheng Li; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Huajun Zhang; CAS Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China
  • Ting Yu; WuHanJinyintan Hospital, Wuhan, China
  • Jieming Qu; Department of Respiratory and Critical Care Medicine, National Research Center for Translational Medicine (Shanghai),Institute of Respiratory Diseases, Ruijin H
  • Min Zhou; Department of Respiratory and Critical Care Medicine, National Research Center for Translational Medicine (Shanghai),Institute of Respiratory Diseases, Ruijin H
  • Li Chen; Clinical Research Center, Department of Gastroenterology, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • Shengli Meng; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd. ,Wuhan, China
  • Yong Hu; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Cheng Peng; CAS Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China
  • Mingchao Yuan; Wuhan Blood Center, Wuhan, China
  • Jinyan Huang; State Key Laboratory of Medical Genomics, Shanghai Institute of Hematology, National Research Center for Translational Medicine (Shanghai), Ruijin Hospital, Sha
  • Zejun Wang; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Jianhong Yu; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Xiaoxiao Gao; CAS Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China
  • Dan Wang; Wuhan Blood Center, Wuhan, China
  • Xiaoqi Yu; Research Laboratory of Clinical Virology, Ruijin Hospital and Ruijin Hospital North, National Research Center for Translational Medicine (Shanghai), Shanghai Ji
  • Li Li; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Jiayou Zhang; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Xiao Wu; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Bei Li; CAS Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China
  • Yanping Yu; Department of Respiratory and Critical Care Medicine, National Research Center for Translational Medicine (Shanghai),Institute of Respiratory Diseases, Ruijin H
  • Wei Chen; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Yan Peng; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Yeqin Hu; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Lianzhen Lin; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Xuefei Liu; Department of Respiratory and Critical Care Medicine, National Research Center for Translational Medicine (Shanghai),Institute of Respiratory Diseases, Ruijin H
  • Shihe Huang; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Zhijun Zhou; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Lianghao Zhang; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Yue Wang; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Zhi Zhang; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Kun Deng; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Zhiwu Xia; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co.Ltd., Wuhan, China
  • Qin Gong; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Wei Zhang; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Xiaobei Zheng; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Ying Liu; Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd, Wuhan, China
  • Huichuan Yang; China National Biotec Group Company Limited, Beijing, China
  • Dongbo Zhou; China National Biotec Group Company Limited, Beijing, China
  • Ding Yu; China National Biotec Group Company Limited, Beijing, China
  • Jifeng Hou; National Institute for Food and Drug Control of China, Beijing, China
  • Zhengli Shi; CAS Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, China
  • Saijuan Chen; State Key Laboratory of Medical Genomics, Shanghai Institute of Hematology, National Research Center for Translational Medicine (Shanghai), Ruijin Hospital, Sha
  • Zhu Chen; State Key Laboratory of Medical Genomics, Shanghai Institute of Hematology, National Research Center for Translational Medicine (Shanghai), Ruijin Hospital, Sha
  • Xin-xin Zhang; Research Laboratory of Clinical Virology, Ruijin Hospital and Ruijin Hospital North, National Research Center for Translational Medicine (Shanghai), Shanghai Ji
  • Xiaoming Yang; China National Biotec Group Company Limited, National Engineering Technology Research Center for Combined Vaccines, Wuhan, China
Preprint em Inglês | medRxiv | ID: ppmedrxiv-20036145
ABSTRACT
Currently, there are no approved specific antiviral agents for 2019 novel coronavirus disease (COVID-19). In this study, ten severe patients confirmed by real-time viral RNA test were enrolled prospectively. One dose of 200 mL convalescent plasma (CP) derived from recently recovered donors with the neutralizing antibody titers above 1640 was transfused to the patients as an addition to maximal supportive care and antiviral agents. The primary endpoint was the safety of CP transfusion. The second endpoints were the improvement of clinical symptoms and laboratory parameters within 3 days after CP transfusion. The median time from onset of illness to CP transfusion was 16.5 days. After CP transfusion, the level of neutralizing antibody increased rapidly up to 1640 in five cases, while that of the other four cases maintained at a high level (1640). The clinical symptoms were significantly improved along with increase of oxyhemoglobin saturation within 3 days. Several parameters tended to improve as compared to pre-transfusion, including increased lymphocyte counts (0.65x109/L vs. 0.76x109/L) and decreased C-reactive protein (55.98 mg/L vs. 18.13 mg/L). Radiological examinations showed varying degrees of absorption of lung lesionswithin 7 days. The viral load was undetectable after transfusion in seven patients who had previous viremia. No severe adverse effects were observed. This study showed CP therapy was welltolerated and could potentially improve the clinical outcomes through neutralizing viremia in severe COVID-19 cases. The optimal dose and time point, as well as the clinical benefit of CP therapy, needs further investigation in larger well-controlled trials. Significance StatementCOVID-19 is currently a big threat to global health. However, no specific antiviral agents are available for its treatment. In this work, we explored the feasibility of convalescent plasma (CP) transfusion to rescue severe patients. The results from 10 severe adult cases showed that one dose (200 mL) of CP was welltolerated and could significantly increase or maintain the neutralizing antibodies at a high level, leading to disappearance of viremia in 7 days. Meanwhile, clinical symptoms and paraclinical criteria rapidly improved within 3 days. Radiological examination showed varying degrees of absorption of lung lesions within 7 days. These results indicate that CP can serve as a promising rescue option for severe COVID-19 while the randomized trial is warranted.
Licença
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Texto completo: Disponível Coleções: Preprints Base de dados: medRxiv Tipo de estudo: Experimental_studies / Estudo prognóstico / Rct Idioma: Inglês Ano de publicação: 2020 Tipo de documento: Preprint
Texto completo: Disponível Coleções: Preprints Base de dados: medRxiv Tipo de estudo: Experimental_studies / Estudo prognóstico / Rct Idioma: Inglês Ano de publicação: 2020 Tipo de documento: Preprint
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