- Clinical trial will recruit approximately 1400 patients in 10 countries starting in July
- Participants will be randomised to receive the low molecular weight Heparin enoxaparin or current standard of care for up to 3 weeks from the time of diagnosis
- The study is supported through an investigator initiated grant from Sanofi
London, June 26th
TRI will conduct an open-label clinical trial of community-based early thromboprophylaxis named ETHIC (Early Thromboprophylaxis in COVID-19). Eligible patients will have newly-diagnosed Covid-19 and also have been identified with an increased risk of complications of infection due to age and comorbidities.
The study was designed in response to recent evidence suggesting that severe COVID-19 infections are associated with increased frequency of thrombosis.
The study will examine the hypothesis that intervention with low thromboprophylactic doses of low molecular weight Heparin administered early in the natural history of COVID 19 disease might reduce hospitalisation and mortality in higher risk patients with Sars Cov 2 infection.
Symptomatic patients with COVID-19 receiving the LMWH (via enoxaparin) will be compared with patients receiving the standard of care. The follow up period for assessing outcomes including hospitalization and mortality is at 21 days, with further assessments at 50 days and 90 days.
The study will be funded by an investigator-initiated study grant provided by Sanofi.
TRI Director Lord Ajay Kakkar said: “Our understanding of the role of thrombosis and anticoagulation in COVID-19 is rapidly evolving. We greatly appreciate the opportunity to engage our global network of researchers in the evaluation of anticoagulation in COVID-19 in the community setting for the first time. We are immensely grateful to the colleagues and patients who will participate in this important study.”
The Thrombosis Research Institute is a leader in innovative solutions for the prevention and management of thrombosis. Sanofi is a global biopharmaceutical company focused on improving human health.