Document Type

Article

Journal Title

PLoS One

Publication Date

2026

Volume

21

Abstract

BACKGROUND: Though Bayesian methods are flexible, intuitive, and readily incorporated into clinical decision-making, with particular utility when prior information is available, they remain underutilized in the analysis of clinical trials.

METHODS: In PINETREE, a Phase 3 randomized controlled trial (RCT) of remdesivir (RDV) for the treatment of outpatients with COVID-19 at high risk of severe disease, the primary outcome of COVID-19-related hospitalization or all-cause death was reanalyzed using a range of reference and data-driven priors. Posterior probability distributions were used to calculate the probability that the estimated hazard ratio (HR) was below a range of clinically meaningful specified thresholds and to estimate the treatment effect and its 95% credible interval (CrI).

RESULTS: Under a minimally informative prior, the posterior probability of an estimated HR less than 1 for COVID-19-related hospitalization or all-cause death was 1 with a posterior median HR 0.13 and 95% CrI 0.02-0.47, recovering the frequentist estimates. Moreover, estimated posterior probability distributions, posterior median HRs, and 95% CrIs were robust across a range of both reference and data-driven prior choices, indicating the strength of the trial data. Lastly, using priors that incorporate historical RCT data, precision of the estimated posterior median HR and 95% CrI was improved over naïve, frequentist estimates.

CONCLUSIONS: In a Bayesian reanalysis of the PINETREE trial, there was a 98.9% or greater probability that treatment with RDV reduced the risk of COVID-19-related hospitalization or all-cause death across all prior probability distributions.

MeSH Headings

Humans, Adenosine Monophosphate, Alanine, Bayes Theorem, COVID-19 Drug Treatment, Antiviral Agents, COVID-19, Outpatients, SARS-CoV-2, Disease Progression, Hospitalization, Female, Male, Middle Aged, Aged

ISSN

1932-6203

Creative Commons License

Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

Share

COinS