A brief note on randomized controlled trials and compassionate/off-label use of drugs in the early phases of the COVID-19 pandemic

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Abstract

Randomized controlled trials (RCTs) are the best way to find effective and acceptable safe treatments for COVID-19 and any possible future outbreak. However, caution is needed when comparing the number of participants in RCTs with that of patients with COVID-19 treated with compassionate and/or off-label drugs to support the hypothesis that the latter are preferred by clinicians as an alternative to the former.

Keywords: compassionate, coronavirus, COVID-19, off-label, RCT, SARS-CoV-2

Citation: Bassetti M, Pelosi P, Robba C, Vena A, Giacobbe DR. A brief note on randomized controlled trials and compassionate/ off-label use of drugs in the early phases of the COVID-19 pandemic. Drugs in Context 2020; 9: 2020-5-2. DOI: 10.7573/dic.2020-5-2

Contributions: M Bassetti, P Pelosi, and DR Giacobbe participated in the manuscript concept and design; M Bassetti and DR Giacobbe drafted the manuscript and critically revised the manuscript for important intellectual content; A Vena, C Robba, and P Pelosi critically revised the manuscript for important intellectual content. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: Outside the submitted work, M Bassetti has received funding for scientific advisory boards, travel and speaker honoraria from Angelini, Astellas, AstraZeneca, Basilea, Bayer, BioMèrieux, Cidara, Correvio, Cubist, Menarini, Molteni, MSD, Nabriva, Paratek, Pfizer, Roche, Shionogi, Tetraphase, Thermo Fisher, and The Medicine Company. Outside the submitted work, DR Giacobbe reports honoraria from Stepstone Pharma GmbH and unconditional grants from MSD Italia and Correvio Italia. No other conflicts of interests were reported. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2020/05/dic.2020-5-2-COI.pdf

Acknowledgements: None.

Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2020 Bassetti M, Pelosi P, Robba C, Vena A, Giacobbe DR. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2020 Bassetti M, Pelosi P, Robba C, Vena A, Giacobbe DR. https://doi.org/10.7573/dic.2020-5-2. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/a-brief-note-on-randomized-controlled-trials-and-compassionate-off-label-use-of-drugs-in-the-early-phases-of-the-covid-19-pandemic

Correspondence: Matteo Bassetti, Clinica Malattie Infettive, Ospedale Policlinico San Martino – IRCCS, L.go R. Benzi 10, 16132 – Genoa, Italy. matteo.bassetti@unige.it

Provenance: submitted; externally peer reviewed.

Submitted: 6 May 2020; Peer review comments to author: 11 May 2020; Revised manuscript received: 11 May 2020; Accepted: 11 May 2020; Publication date: 26 May 2020.

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