Original Investigation June 3, 2020<\/p>\n\n\n\n
Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.<\/p>\n\n\n\n
To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Convalescent plasma in addition to standard treatment (n\u2009=\u200952) vs standard treatment alone (control) (n\u2009=\u200951), stratified by disease severity.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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, \u221210.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49];\u00a0P<\/em>\u2009=\u2009.26). 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];\u00a0P<\/em>\u2009=\u2009.03); 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];\u00a0P<\/em>\u2009=\u2009.83) (P<\/em>\u00a0for interaction\u2009=\u2009.17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.65 [95% CI, 0.29-1.46];\u00a0P<\/em>\u2009=\u2009.30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.93];\u00a0P<\/em>\u2009=\u2009.12). 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];\u00a0P<\/em>\u2009<\u2009.001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.<\/p>\n\n\n\n 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.<\/p>\n\n\n\nConclusion and Relevance<\/strong><\/h3>\n\n\n\n
Trial Registration<\/strong><\/h3>\n\n\n\n