Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial

This study is unblinded.Numbers to be randomised (sample size)30 patients treated by COVID-19 infection who require hospitalisation: 20 will receive sarilumab plus Standard of Care and 10 will receive Standard of Care.Trial StatusThe Protocol version number is 2, as of 6th April 2020, with amendment 1, as of 7th May 2020. The recruitment is ongoing. Recruitment started on April 13th 2020 and is anticipated to be completed by November 2020.Trial registrationThis trial was first registered in the European Union Clinical Trials Register on 4 April 2020, EudraCT Number2020-001634-36. Then, posted on ClinicalTrials.gov on 22 April 2020, Identifier:NCT04357808.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.The study protocol has been reported in accordance with the International Council Harmonization guidelines:https://www.ich.org/page/efficacy-guidelines.
Source: Trials - Category: Research Source Type: clinical trials