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2020 ; 324
(5
): 460-470
Nephropedia Template TP
gab.com Text
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English Wikipedia
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?.001). Two patients in the convalescent plasma group experienced
adverse events within hours after transfusion that improved with supportive care.
CONCLUSION AND RELEVANCE: 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. TRIAL REGISTRATION: Chinese Clinical
Trial Registry: ChiCTR2000029757.