DEFEAT- Covid Study [COVID-19]
Research type
Research Study
Full title
Targeting de novo Pyrimidine Biosynthesis by leflunomide as a Novel Concept for the Treatment of Corona Virus Disease 2019 (COVID-19)
IRAS ID
283052
Contact name
Zhong Chen
Contact email
Sponsor organisation
Ashford and St Peter's Hospitals NHS Foundation Trust
Eudract number
2020-002952-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Current understanding of the COVID-19 pandemic show that a very significant fraction of infected patients develops pneumonia, systemic inflammatory response and cardiovascular complications with high morbidity and mortality. So far, there is a lack of consensus on the efficacy and safety of various treatment options targeting either the host (patients) or directly the virus. Our in vitro and in vivo evidence showed that, Leflunomide, a well established drug used to treat rheumatoid arthritis, has dual antiviral and anti-inflammatory properties. We propose a multicenter randomised clinical trial (3 UK NHS institutions, with a target total number of 178 to evaluate the efficacy and safety of Leflunomide compared with contemporary standard of care (as per emerging UK guidelines) in COVID-19 patients with moderate to critical clinical symptoms. The primary focus will be on clinical progression (complications and speed of recovery) and on kinetics of viral clearance. Additional objectives will centre on physiological and inflammatory events in relation to lung, heart and kidney dysfunction and severity of the systemic inflammatory reaction.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0264
Date of REC Opinion
21 Jul 2020
REC opinion
Further Information Favourable Opinion