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10.1001/jama.2020.10044

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suck abstract from ncbi


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pmid32492084
      JAMA 2020 ; 324 (5 ): 460-470
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  • Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial #MMPMID32492084
  • Li L ; Zhang W ; Hu Y ; Tong X ; Zheng S ; Yang J ; Kong Y ; Ren L ; Wei Q ; Mei H ; Hu C ; Tao C ; Yang R ; Wang J ; Yu Y ; Guo Y ; Wu X ; Xu Z ; Zeng L ; Xiong N ; Chen L ; Wang J ; Man N ; Liu Y ; Xu H ; Deng E ; Zhang X ; Li C ; Wang C ; Su S ; Zhang L ; Wang J ; Wu Y ; Liu Z
  • JAMA 2020[Aug]; 324 (5 ): 460-470 PMID32492084 show ga
  • IMPORTANCE: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed. OBJECTIVE: To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTION: Convalescent plasma in addition to standard treatment (n?=?52) vs standard treatment alone (control) (n?=?51), stratified by disease severity. MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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?
  • |Aged [MESH]
  • |Aged, 80 and over [MESH]
  • |Betacoronavirus/*immunology [MESH]
  • |Blood Component Transfusion [MESH]
  • |COVID-19 [MESH]
  • |COVID-19 Serotherapy [MESH]
  • |China [MESH]
  • |Combined Modality Therapy [MESH]
  • |Coronavirus Infections/mortality/*therapy [MESH]
  • |Female [MESH]
  • |Humans [MESH]
  • |Immunization, Passive/adverse effects [MESH]
  • |Male [MESH]
  • |Middle Aged [MESH]
  • |Pandemics [MESH]
  • |Patient Acuity [MESH]
  • |Pneumonia, Viral/mortality/*therapy [MESH]
  • |SARS-CoV-2 [MESH]


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