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Clinical trial of Gilead’s coronavirus hopeful remdesivir begins in UK

The pair of phase 3 trials will take place across 15 clinical sites in the UK

Gilead

Gilead Sciences has started a pair of phase 3 trials of its experimental antiviral drug remdesivir in the UK in patients with moderate-to-severe COVID-19, with results expected within weeks.

The two studies will take place across 15 clinical sites in the UK, as the country sees its biggest daily increase in deaths from coronavirus of 563, taking the total number of fatalities in the country to 2,352.

The trials – one for severely ill patients and the other for moderate cases of COVID-19 – have been fast-tracked and given urgent public health research (UPHR) status by the Chief Medical Office, a process which can shorten the approval time for testing to a matter of hours in some cases.

“These clinical trials will help generate important data on the safety and efficacy of the medication in the coming weeks,” said Hilary Hutton-Squire, general manager of Gilead Sciences UK & Ireland.

The company started US testing of remdesivir in February, and it is also being studied in two Chinese trials, with great anticipation of the results due in the next few weeks as confirmed cases of coronavirus head towards the one million threshold worldwide.

Remdesivir is a nucleotide analogue that disrupts viruses’ RNA genome, and has been in development for a decade. It was originally intended as a treatment for Ebola, before its potential in treating SARS-CoV-2 infections was identified.

It has also had preliminary testing in two other coronavirus strains that caused outbreaks – SARS and MERS – which raised confidence that it might have some activity against this type of virus.

The UK trials will run in England and Scotland and be overseen by Dr Andy Ustianowski, an infectious disease consultant based at North Manchester General Hospital.

Meanwhile, two further phase 3 trials of the drug have also been launched across hospitals in France, Italy, Spain and Germany, once again following the format of one trial apiece in moderate and severe infections.

The trials will each enrol several hundred patients and will investigate a 14-day course of remdesivir, with endpoints including normalisation of fever and increased oxygen saturation in the blood in the trials involving seriously ill patients.

The studies in moderate cases will look at hospital discharge rates within the 14-day follow-up period, among other outcome measures.

With a vaccine for COVID-19 still at least 12-18 months away, the race is on to find drug treatments that will save lives in patients who get the virus more severely.

Around 20 other drug candidates are now in trials, including malaria drugs chloroquine and hydroxychloroquine that are reported to be in short supply since news of their potential as treatments first emerged.

President Donald Trump hailed the antimalarial’s potential at a press conference last months – ahead of mixed results in a clinical trial – with the FDA clearing them for emergency use shortly afterwards. He is now said to be doing the same with Fujifilm’s influenza antiviral Avigan (favipiravir).

Article by
Phil Taylor

2nd April 2020

From: Research

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