NCT04373707.

Study name	Effectiveness of weight‐adjusted prophylactic low molecular weight heparin doses compared with lower fixed prophylactic doses to prevent venous thromboembolism in COVID‐2019. The multicenter randomized controlled open‐label trial COVI‐DOSE
Starting date	13 May 2020
Contact information	Yohann Bernard Central Hospital, Nancy, France +33.3.83.15.52.72 | y.bernard@chru‐nancy.Fr
Methods	Multicenter, open‐label, 2‐armed, parallel‐assignment RCT; stratified on disease severity (admission to ICU or not)
Participants	602 participants, ≥ 18 years, female and male Inclusion criteria Adult patient hospitalised for a probable/confirmed COVID‐19 infection (confirmed by serology/PCR or by radiologic signs of COVID‐19 pneumonia in the setting of clinical and laboratory abnormalities suggestive of a SARS‐CoV‐2 infection) Signed informed consent Patient affiliated to Social Security Exclusion criteria Renal insufficiency with a GFR < 15 mL/min/1.73 m² AKI KDIGO3 Prophylactic dose of LMWH for > 3 days Curative dose of LMWH for > 1 day Recurrent catheter/haemodialysis access thromboses ECMO required in the next 24 h Contraindication to LMWH High bleeding risk (e.g. uncontrolled severe systemic hypertension, recent major bleeding, disseminated intravascular coagulopathy, thrombocytopenia < 75 g/L) History of HIT Contraindication to blood‐derived products Impossibility to perform a doppler ultrasound of the lower limbs (e.g. above the knee amputation, severe burn injuries) Expected death in the next 48 h Vulnerable patients according to articles L. 1121‐5, L. 1121‐7 et L1121‐8 of French Public Health Code
Interventions	Experimental: weight‐adjusted prophylactic dose LMWH For example (enoxaparin): 4000 IU twice a day in participants < 50 kg 5000 IU twice a day in participants 50‐70 kg 6000 IU twice a day in participants 70‐100 kg 7000 IU twice a day in participants above 100 kg Other names: tinzaparin, nadroparin, dalteparin Comparator: low prophylactic dose of LMWH For example (enoxaparin): from 4000 IU once a day in participants admitted in medical ward to 4000 IU twice a day in participants admitted in the ICU. In participants with severe renal insufficiency (GFR = 15‐30 mL/min/1.73 m²), LMWH doses will be reduced by 50%. Other names: tinzaparin, nadroparin, dalteparin
Outcomes	Primary VTE (time frame: 28 days). Risk of DVT or PE or VTE‐related death Secondary Major bleeding (time frame: 28 days). Risk of major bleeding defined by the ISTH Major bleeding and clinically relevant non‐major bleeding (time frame: 28 days). Risk of major bleeding and clinically relevant non‐major bleeding defined by the ISTH Net clinical benefit (time frame: 28 days and 2 months). Risk of VTE and major bleeding VTE at other sites (time frame: 28 days). Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, haemodialysis access, ECMO, splanchnic, encephalic, upper limb Arterial thrombosis (time frame: 28 days). Risk of arterial thrombosis at any site All‐cause mortality (time frame: 28 days and 2 months). Risk of all‐cause mortality Factors associated with the risk of VTE (time frame: 28 days). Identification of associations between the risk of VTE and clinical (e.g. past medical history of thrombosis, cardiovascular risk factors, treatments, severity of COVID‐19) and laboratory variables (e.g. D‐dimers, fibrinogen, C‐reactive protein) collected in the electronic Case Report Form
Notes	NCT04373707 | 2020‐001709‐21 | No data provided