Gilead expand UK sites for two phase-3 studies of remdesivir to treat COVID-19
17 April 2020. Related: COVID-19: investigational drugs, COVID-19: research studies, COVID-19.
Simon Collins, HIV i-Base
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.
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]
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]
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]
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.
The 15 UK sites include five London clinics and ten centres across the rest of the UK.
- Royal Free London NHS Foundation Trust.
- London North West University Healthcare NHS Trust.
- University College London Hospitals NHS Foundation Trust.
- King’s College Hospital NHS Foundation Trust.
- Imperial College Healthcare NHS Trust.
- Liverpool University Hospitals NHS Foundation Trust.
- Manchester Royal Infirmary.
- Sheffield Teaching Hospitals NHS Foundation Trust (adult services).
- Wythenshawe Hospital.
- Hull University Teaching Hospitals NHS Trust.
- The Pennine Acute Hospitals NHS Trust.
- Royal Lancaster Infirmary.
- Glasgow Queen Elizabeth University Hospital.
- Edinburgh Western General Hospital.
- University Hospitals Plymouth NHS Trust.
References
- Gilead press statement. Gilead Sciences announces two phase 3 randomised studies to evaluate the safety and antiviral activity of remdesivir (GS-5734tm) in participants with moderate to severe COVID-19. (1 April 2020). Not posted online.
- Gilead press statement. Gilead Sciences initiates two phase 3 studies of investigational antiviral remdesivir for the treatment of COVID-19. (26 February 2020).
https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19 - ClinicalTrial.gov. GS-US-540-5773 (EudraCT Number: 2020-000841-15): A phase 3 randomized study to evaluate the safety, and antiviral activity of remdesivir (GS-5734) in participants with severe COVID-19.
https://clinicaltrials.gov/ct2/show/NCT04292899 - ClinicalTrial.gov. GS-US-540-5774 (EudraCT Number: 2020-000842-32): A phase 3 randomized study to evaluate the safety, and antiviral activity of remdesivir (GS-5734) in participants with moderate COVID-19 compared to standard of care treatment.
https://clinicaltrials.gov/ct2/show/NCT04292730 - Gilead Sciences. Personal communication (6 April 2020).