24 July 2020

Report by
Dominic Bowers, Head of Rare Diseases & Advanced Therapeutics, tranScrip
Flic Gabbay, Managing Partner, tranScrip
Sarah Daniels, Head of Drug Safety, Pharmacovigilance & Risk Management, tranScrip

The emerging profile for remdesivir demonstrates efficacious and well tolerated administration in patients hospitalised with moderate to severe COVID-19 infection. Administration of remdesivir has shown a significant reduction in symptom duration and early signs suggest that it may reduce all-cause mortality. Data is emerging to support selected use of longer duration 10-day administration of remdesivir in more severe disease in patients who require mechanical ventilation and/or ECMO. Results of the extension phases of the two SIMPLE studies and readouts of other ongoing studies will assist establishment of best practice for the administration of remdesivir safely in the management of COVID-19 infection.

A degree of caution should be exercised until the completion of ongoing studies and subsequent careful analysis in accordance with a benefit-risk profile. The safety profile of remdesivir is evolving and not fully established. However, the current safety profile presented by the completed clinical trials presented in this article has not raised any signals of undue risk.

Adherence to high quality clinical trial design, including the WHO Working Group minimum data set recommendations, when planning future clinical studies and diligent conduct and analysis should be maintained whilst the pace to discover efficacious and safe therapeutics for COVID-19 infection continues.

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