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Statistical review of Triple combination of interferon beta-1b, lopinavir–ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial

Kahan, Brennan; Hood, Kerry; Dahly, Darren

The following review has been prepared in collaboration with members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers named above, and other, unnamed discussants of the paper, are all qualified statisticians with experience in clinical trials. Our objective is to provide a rapid review of publications, preprints and protocols from clinical trials of COVID-19 treatments independent of journal specific review processes. We aim to provide timely, constructive, focused, clear advice aimed at improving both the research outputs under review, as well as future studies. Given our collective expertise (clinical trial statistics) our reviews focus on the designs of the trials and other statistical content (methods, presentation and accuracy of results, inferences). This review reflects the expert opinions of the named authors, and does not imply endorsement by the MRC-NIHR Trials Methodology Research Partnership, its wider membership, or any other organization. Here we review Triple combination of interferon beta-1b, lopinavir–ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial, by Hung et al, published in the Lancet on the 8th May.

Overall, this was a well-conducted randomised controlled trial with a few deficiencies in how it was reported and analysed, though none of these were disqualifying. The observed outcomes were consistently in favor of the group receiving triple therapy that included interferon beta-1b, ribavirin, and lopinavir–ritonavir (compared to the group that only received lopinavir–ritonavir), though, as pointed out by the authors, this was in patients with mild to moderate COVID-19, and so the results may not be generalisable to patients with more severe illness.  

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