Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19 (NCT04646655) | Clinical Trial Compass
CompletedPhase 3
Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19
Italy142 participantsStarted 2020-07-27
Plain-language summary
SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or increased D-dimer levels enrolled in different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* COVID-19 related pneumonia with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or markedly increased D-dimer level (\>2000 ng/mL)
* Signed informed consent
Exclusion Criteria:
* age \< 18 and \> 80 yrs
* history of bleeding (peptic ulcer, esophageal varices, cerebral aneurysm, cancer at high risk of bleeding, cirrhosis, hemorrhagic stroke \< 1 year)
* thrombocytopenia (\<100 x109/L)
* anemia (Hb \< 8 g/dl)
* coagulation abnormalities (PT e/o aPTT \> 1.5; fibrinogen \< 150 mg/dl)
* consumption coagulopathy (ISTH criteria) \[15, 16\]
* deep vein thrombosis or pulmonary embolism
* dual antiplatelet therapy
* ongoing anticoagulant therapy
* allergic reaction to LMWH
* previous heparin-induced thrombocytopenia
* major surgery \< 1 month; neurosurgery \<3 months; eye surgery \<3 months
* pregnancy
* arterial hypertension (SBPS\>160 mm Hg; DBP\>100 mm Hg)
* renal failure (creatinine clearance 30 ml/min)
* ICU admission or endotracheal intubation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.