07 July 2020

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

Introduction

The death toll of COVID-19 is now over 500,000 and the search for effective antivirals has been intense. Whilst many drugs have shown in vitro activity, comparative clinical studies have been completed for only three; hydroxychloroquine (HCQ), lopinavir/ritonavir and remdesivir. HCQ and remdesivir were both approved in the United States (US) for emergency use authorisation (EUA), but on 15th June the Food and Drug Administration (FDA) revoked the EUA for HCQ citing recently available clinical study data. The following day, The Medicines and Healthcare Products Regulatory Agency (MHRA) instructed United Kingdom (UK) clinical trialists using HCQ to treat or prevent COVID-19 to suspend recruitment of further participants. On 19th June, the World Health Organisation (WHO) stopped the HCQ arm of the SOLIDARITY study, saying data from both the SOLIDARITY and the RECOVERY studies "showed that HCQ does not result in the reduction of mortality of hospitalized COVID-19 patients". However, on 26th June the MHRA gave the green light to continue the ‘COPCOV’ trial investigating HCQ in the prevention of COVID-19, on the grounds that sufficient measures had been taken to support the safe recruitment of further participants. Other studies in pre- and post-exposure prophylaxis are ongoing in other parts of the world.

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