Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
Evidence has shown that COVID-19 infections can lead to an increased risk of blood clots.
These blood clots can lead to individuals being admitted to hospital, or, unfortunately in
severe cases, death. Enoxaparin is a blood-thinning drug which has been used by doctors and
nurses in hospitals for many years to prevent the thickening of blood which may lead to a
clot. It is easier for doctors to prevent new blood clots from forming than treating existing
blood clots.
Currently, there are no treatments for COVID-19. There is an urgent need to find a safe and
effective treatment to prevent worsening of the disease that may lead to hospital admission
and/or death. The ETHIC (Early Thromboprophylaxis in COVID-19) study aims to find out if
giving enoxaparin in an early stage of the COVID-19 disease can prevent individuals being
admitted to hospital and/or death. The study will take place in approximately 8 to 10
countries, in approximately 30 to 50 centres.
Patients will be allowed to take part if they have had a confirmed COVID-19 infection, are ≥
55 years of age and have at least two of the following additional risk factors; age ≥ 70
years, body mass index > 25 kg/m2, chronic obstructive pulmonary disease, diabetes,
cardiovascular disease, or corticosteroid use.
Half the patients in the study will receive the blood-thinning drug enoxaparin for three
weeks, and half will receive no treatment. Individuals will be randomly allocated to one of
these groups. After 21 days, the number of patients in each group who were either admitted to
hospital, or died, will be compared. The number of patients in each group who developed a
blood clot (venous thromboembolism) will also be compared. Further comparisons will be made
at both 50 and 90 days after the beginning of the study.