COVID-19 research brief: convalescent plasma marginally improved COVID-19 outcomes in severely ill patients in China

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Published: 2020-07-19 © 2020 John Wiley & Sons, Inc.

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Clinical question
What are the effects of convalescent plasma in patients with COVID-19?

Bottom line
Convalescent plasma marginally increased the rates of clinical improvement in severely ill patients in China, but these results are compromised by the early termination of the trial. (LOE = 2b)

Li L, Zhang W, Hu Y, et al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial. JAMA. Published online June 3, 2020. doi:10.1001/jama.2020.10044

Study design: Randomized controlled trial (nonblinded)

Allocation: Unconcealed

Setting: Outpatient (any)

Research Brief # 41: In this open-label multicenter randomized clinical trial, 103 patients (median age 70) with severe or life-threatening COVID-19 infection in Wuhan, China, were randomized to receive convalescent plasma or no convalescent plasma. The primary outcome was time to clinical improvement — defined as either patient discharge or a reduction of 2 points on a 6-point disease severity scale (1 = discharged, 6 = death) — within 28 days. Clinical improvement occurred in 52% (27/52) of the patients in the convalescent plasma group and 43% (22/51) in the control group, which was not statistically significant (hazard ratio [HR] 1.40; 95% CI 0.79 - 2.49; P = .26). Among those with severe disease, the primary outcome occurred in 91% (21/23) of the convalescent plasma group versus 68% (15/22) of the control group (HR 2.15; 1.07 - 4.32; P = .03); among those with life-threatening disease (the most severely ill patients) the primary outcome occurred in 21% (6/29) of the convalescent plasma group versus 24% (7/29) of the control group (HR 0.88; 0.30 - 2.63; P = .83). There was no significant difference in 28-day mortality (15.7% vs 24.0%; odds ratio 0.65; 0.29 - 1.46; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR 1.61; 0.88 - 2.93; P = .12). The trial was terminated after 103 of the planned 200 patients were enrolled because of the rapid decline in COVID-19 cases in Wuhan. A larger study is needed to confirm or refute the results from this underpowered randomized controlled trial

John Hickner, MD, MS
Professor Emeritus
Dept of Family Medicine
Michigan State University
East Lansing, MI

Copyright © 2020 John Wiley & Sons, Inc.