NCT04444700.

Study name	Utilização da enoxaparina em dose anticoagulante em pacientes hospitalizados com síndrome respiratória aguda grave por COVID‐19
Starting date	4 July 2020
Contact information	Hassan Rahhal, MD Hospital das Clínicas da FMUSP São Paulo, SP, Brazil, 05402‐000 +551126619033 | hassan.r@hc.fm.usp.br
Methods	Open‐label, parallel‐assignment RCT
Participants	462 participants, ≥ 18 years, female and male Inclusion criteria laboratory‐confirmed diagnosis of SARS‐CoV‐2 as per the WHO protocols admitted to hospital ≥ 18 years of age oxygen saturation < 94% informed consent from the patient (or legally authorised substitute decision maker) Exclusion criteria: pregnancy haemoglobin < 80 g/L in the last 72 h platelet count < 50 x 109/L in the last 72 h known fibrinogen < 1.5 g/L (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation) known INR > 1.8 (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation) patient already on intermediate dosing of LMWH that cannot be changed (determination of what constitutes an intermediate dose is to be at the discretion of the treating clinician taking the local institutional thromboprophylaxis protocol for high‐risk patients into consideration) patient already on therapeutic anticoagulation at the time of screening (low‐ or high‐dose nomogram UFH, LMWH, warfarin, DOAC (any dose of dabigatran, apixaban, rivaroxaban, edoxaban) patient on dual antiplatelet therapy, when one of the agents cannot be stopped safely known bleeding within the last 30 days requiring emergency room presentation or hospitalisation known history of a bleeding disorder of an inherited or active acquired bleeding disorder known history of HIT known allergy to UFH or LMWH admitted to the ICU at the time of screening treated with non‐invasive positive pressure ventilation or invasive mechanical ventilation at the time of screening
Interventions	Experimental: therapeutic anticoagulation Therapeutic anticoagulation with enoxaparin 1 mg/kg twice daily will be administered until discharged from the hospital or after 7 days, whichever is longer, or death If the patient is admitted to the ICU or requiring ventilatory support, we recommend the continuation of the allocated treatment as long as the treating physician is in agreement. Comparator: standard care Standard care will be administered until discharged from the hospital or after 7 days, whichever is longer, or death If BMI < 40 kg/m², the treating physician may select one of the following options considered appropriate and available in Brazil Enoxaparin 40 mg once daily, enoxaparin 60 mg once daily, UFH 5000 twice daily, UFH 5,000 three times/d If BMI ≥ 40 kg/m², the treating physician may select one of the following options considered appropriate and available in Brazil: Enoxaparin 40 mg twice daily, UFH 7500 three times/d
Outcomes	Primary Composite main outcome (time frame: up to 28 days) Secondary All‐cause death (time frame: 28 days) Composite outcome of ICU admission or all‐cause death (time frame: 28 days) Major bleeding (time frame: 28 days) Number of participants who received red blood cell transfusion (time frame: 28 days) Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate (time frame: 28 days) Number of hospital‐free days alive up to day 28 (time frame: 28 days) Number of ICU‐free days alive up to day 28 (time frame: 28 days) Number of ventilator‐free days alive up to day 28 (time frame: 28 days) Number of participants with VTE (time frame: 28 days) Number of participants with arterial thromboembolism (time frame: 28 days) Number of participants with HIT (time frame: 28 days)
Notes	NCT04444700 | No data provided