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Clinical Trial
. 2021 Sep 17;224(6):967-975.
doi: 10.1093/infdis/jiab330.

Early Convalescent Plasma Therapy and Mortality Among US Veterans Hospitalized With Nonsevere COVID-19: An Observational Analysis Emulating a Target Trial

Kelly Cho  1   2 , Sarah C Keithly  3 , Katherine E Kurgansky  1 , Arin L Madenci  4 , Hanna Gerlovin  1 , Helen Marucci-Wellman  1 , Annie Doubleday  3 , Eva R Thomas  3 , Yojin Park  1 , Yuk-Lam Ho  1 , Jonathan D Sugimoto  3   5   6 , Kathryn P Moore  3 , Alexander C Peterson  3 , Constance Hoag  1 , Kalpana Gupta  7   8 , Karen Jeans  9 , Molly Klote  9 , Rachel Ramoni  9 , Grant D Huang  9 , Juan P Casas  1   2 , David R Gagnon  1   10 , Miguel A Hernán  4 , Nicholas L Smith  3   5 , J Michael Gaziano  1   2
Affiliations
Clinical Trial

Early Convalescent Plasma Therapy and Mortality Among US Veterans Hospitalized With Nonsevere COVID-19: An Observational Analysis Emulating a Target Trial

Kelly Cho et al. J Infect Dis. .

Abstract

Background: Early convalescent plasma transfusion may reduce mortality in patients with nonsevere coronavirus disease 2019 (COVID-19).

Methods: This study emulates a (hypothetical) target trial using observational data from a cohort of US veterans admitted to a Department of Veterans Affairs (VA) facility between 1 May and 17 November 2020 with nonsevere COVID-19. The intervention was convalescent plasma initiated within 2 days of eligibility. Thirty-day mortality was compared using cumulative incidence curves, risk differences, and hazard ratios estimated from pooled logistic models with inverse probability weighting to adjust for confounding.

Results: Of 11 269 eligible person-trials contributed by 4755 patients, 402 trials were assigned to the convalescent plasma group. Forty and 671 deaths occurred within the plasma and nonplasma groups, respectively. The estimated 30-day mortality risk was 6.5% (95% confidence interval [CI], 4.0%-9.7%) in the plasma group and 6.2% (95% CI, 5.6%-7.0%) in the nonplasma group. The associated risk difference was 0.30% (95% CI, -2.30% to 3.60%) and the hazard ratio was 1.04 (95% CI, .64-1.62).

Conclusions: Our target trial emulation estimated no meaningful differences in 30-day mortality between nonsevere COVID-19 patients treated and untreated with convalescent plasma. Clinical Trials Registration. NCT04545047.

Keywords: COVID-19; SARS-CoV-2; convalescent plasma; coronavirus.

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Figures

Figure 1.
Figure 1.
Flowchart for selection of eligible patients for emulation of a target trial assessing the effectiveness of convalescent plasma on reducing mortality among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–positive veterans hospitalized at a Veterans Affairs (VA) medical center. aEligible trials must start within 2 days after the first day hospitalized with a positive severe acute respiratory syndrome coronavirus 2 test, at a VA medical center where COVID-19 convalescent plasma transfusion was a current practice and at least 1 patient had already received transfusion. bProgression to severe illness was defined as any prior treatment during current hospitalization with high-flow oxygen, mechanical ventilation, dialysis, vasoactive infusion, or extracorporeal membrane oxygenation. cAcute labs included hemoglobin, platelet, white blood cells counts. dVitals included pulse, respiration, temperature, and systolic blood pressure. eOther labs included alanine aminotransferase, albumin, and creatinine.
Figure 2.
Figure 2.
Inverse probability weighted cumulative incidence of 30-day mortality (with 95% confidence intervals) for the target trial of convalescent plasma among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–positive veterans hospitalized at a Veterans Affairs medical center.
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