{"id":37520,"date":"2020-04-17T07:37:46","date_gmt":"2020-04-17T07:37:46","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=37520"},"modified":"2020-05-15T10:01:52","modified_gmt":"2020-05-15T10:01:52","slug":"gilead-announce-two-phase-3-studies-of-remdesivir-to-treat-covid-19-includes-uk-sites","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/37520","title":{"rendered":"Gilead expand UK sites for two phase-3 studies of remdesivir to treat COVID-19"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n

On 1 April 2020, Gilead Sciences announced that two new studies of the investigational compound remdesivir were launched in the UK, in participants with moderate and severe COVID-19. <\/span><\/strong><\/p>\n

These are both part of large international phase 3 studies, announced in February, with more than 100 sites in the US and ten countries in Europe, China and South East Asia. [2]<\/span><\/p>\n

The current listings state the studies will randomise 1000 participants overall to either a five-day or ten-day course of open-label remdesivir (200 mg on day 1 and 100 mg on subsequent days), given as an infusion. The primary composite endpoint is improved clinical outcomes (reduced fever and oxygen normalisation). [3, 4]<\/span><\/p>\n

However, these studies are now expected to enrol more than 4000 participants globally, including in the UK, and clinical outcome at 28 days is included in primary endpoint. Both studies also include safety as secondary endpoints. [5]<\/p>\n

Remdesivir is a nucleotide analogue with broad-spectrum antiviral activity in-vitro to SARS, MERS and Ebola. As part of the early response to CoV-2, remdesivir was one of the first compounds in randomised studies: eleven studies are already ongoing, including early access programmes, with some early results expected within weeks.<\/p>\n

The 15 UK sites include five London clinics and ten centres across the rest of the UK.<\/span><\/p>\n