Statistical review of Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)

Andrew Althouse, Beatriz Goulao, Mike Bradburn

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Abstract

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 Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study by Borba et al.
Original languageEnglish
PublisherZenodo
Number of pages12
DOIs
Publication statusPublished - 20 Apr 2020

Keywords

  • Clinical trials
  • COVID-19
  • Hydroxychloroquine
  • Chloroquine

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