Association of Convalescent Plasma Treatment With Clinical Status in Patients Hospitalized With COVID-19

Abstract

Key Points Question What is the pooled evidence from high-quality randomized clinical trials regarding the safety and potential benefit of convalescent plasma to treat hospitalized patients with COVID-19? Findings In this meta-analysis of 8 randomized clinical trials enrolling 2341 participants, individual patient data were monitored in real time and analyzed using a robust bayesian framework and advanced statistical modeling. No association of convalescent plasma with clinical outcomes was found. Meaning These findings suggest that real-time individual patient data pooling and meta-analysis during a pandemic are feasible, offering a model for future research and providing a rich data resource.

Development and Validation of a Treatment Benefit Index to Identify Hospitalized Patients With COVID-19 Who May Benefit From Convalescent Plasma

“…For the day-14 ordinal WHO score, the posterior median CCP efficacy OR was 0.94 (95% credible interval [CrI], 0.74-1.19). Details appear in Troxel et al 13 The TBIs were developed on 2287 complete cases. The marginal and joint distributions of missing data appear in eFigure 3 in the Supplement .…”

“…There were 3 outcomes (ie, the ordinal WHO 11-point scale, 15 a binary indicator of WHO score 7 to 10 [receiving mechanical ventilation or death], and binary indicator of WHO score 10 [mortality]) at 2 assessment times (ie, 14 ± 1 and 28 ± 2 days post randomization [hereafter day 14 and day 28]). 13 The ordinal WHO scores and the indicators for mechanical ventilation or death at day 14 were coprimary outcomes in COMPILE. The TBIs were developed on the ordinal day-14 WHO score and then tested on all other outcomes.…”

“…While the TBIs were derived on the ordinal WHO score at day 14, efficacy was assessed with respect to all 6 outcomes. ORs were obtained from models used in the main COMPILE analysis 13 , 14 : Bayesian POMs and logistic regressions, adjusted for the same covariates as in the COMPILE analysis with the same prior distributions. Bayesian posterior distributions of the respective ORs were obtained for each benefit level.…”

“…The COMPILE study pooled individual patient data from 8 international RCTs and found no overall association between CCP and patient outcomes. 13 The precision medicine investigations were prespecified in the COMPILE study’s statistical analysis plan. 14 …”

Error in Figure 3

“…In the Original Investigation titled “Association of Convalescent Plasma Treatment With Clinical Status in Patients Hospitalized With COVID-19: A Meta-analysis,” 1 published January 25, 2022, there were errors in Figure 3. The figure labels indicating posterior probabilities of an odds ratio less than .08 should have used “0.8” instead.…”