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

Matteo Bassetti; Paolo Pelosi; Chiara Robba; Antonio Vena; Daniele Roberto Giacobbe

doi:10.7573/dic.2020-5-2

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

Drugs Context. 2020 May 26:9:2020-5-2. doi: 10.7573/dic.2020-5-2. eCollection 2020.

Authors

Matteo Bassetti^{1

2}, Paolo Pelosi^{3

4}, Chiara Robba⁴, Antonio Vena^{1

2}, Daniele Roberto Giacobbe^{1

2}

Affiliations

¹ Infectious Diseases Unit, Ospedale Policlinico San Martino - IRCCS, Genoa, Italy.
² Department of Health Sciences, University of Genoa, Genoa, Italy.
³ Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.
⁴ Anaesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS, Genoa, Italy.

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: COVID-19; RCT; SARS-CoV-2; compassionate; coronavirus; off-label.

Publication types

Editorial