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IRCT20220412054515N1 IRCT 2022-05-04 Tehran University of Medical Sciences Prophylactic vs. therapeutic enoxaparin in severe COVID-19 Comparison of enoxaparin effects with prophylactic or therapeutic dosage on overall survival in severe COVID-19 patients 2022-05-15 anticipated 220 Complete https://irct.ir/trial/62908 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Individual patients were randomized in a 1:1 ratio, using block randomization with a computer-generated random allocation algorithm. allocations were concealed until randomization. 3 COVID-19. Intervention 1: Intervention group: Therapeutic dose enoxaparin group: subcutaneous injections of enoxaparin, 1 mg/Kg, Twice a day, Tehran Chemie Co., if patients had a GFR lower than 30 mL/min injections were administered only once a day. Intervention 2: Control group: Prophylactic dose enoxaparin group: subcutaneous injections of enoxaparin, 40 mg, once a day, Tehran Chemie Co., if patients had a GFR lower than 30 mL/min, 30 mg dose was used, in cases of a BMI greater than 40 injections were administered twice a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohammadreza Fattahi
Sina Hospital, Imam-Khomeini street, Hassan-Abad square
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6656 4517 mr-fattahi@alumnus.tums.ac.ir Tehran University of Medical Sciences scientific Mohammadreza Fattahi
Sina Hospital, Imam-Khomeini street, Hassan-Abad square
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6656 4517 mr-fattahi@alumnus.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) COVID-19 infection diagnosed by PCR Hospitalization requirement Having at least two signs of severe COVID-19 infection: (1) respiratory rate>30 (2) Spo2<93% (3) Pao2/Fio2<300 (4) progression in CT scan imaging>50% in 48 hours 18 years no limit Both Pregnancy History of CVA in last month History of major surgery in last two weeks History of heparin induced thrombocytopenia Other definitive indications for therapeutic enoxaparin treatment Any contraindication for enoxaparin treatment U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Therapeutic dose enoxaparin group: subcutaneous injections of enoxaparin, 1 mg/Kg, Twice a day, Tehran Chemie Co., if patients had a GFR lower than 30 mL/min injections were administered only once a day Control group: Prophylactic dose enoxaparin group: subcutaneous injections of enoxaparin, 40 mg, once a day, Tehran Chemie Co., if patients had a GFR lower than 30 mL/min, 30 mg dose was used, in cases of a BMI greater than 40 injections were administered twice a day. Cumulative 6-month survival. Timepoint: 6 months after admission. Method of measurement: Visit or phonecall. Hospitalization duration (days). Timepoint: After discharge or death. Method of measurement: Patient files. Need for Intensive Care Unit admission. Timepoint: After discharge or death. Method of measurement: Patient files. Need for mechanical ventilation. Timepoint: After discharge or death of patient. Method of measurement: Patient files. Major bleeding defined by International Society on Thrombosis and Haemostasis criteria. Timepoint: After discharge or death. Method of measurement: Patient files. Tehran University of Medical Sciences Approved 2022-05-01 Research Ethics Committees of Sina Hospital Sina Hospital, Hassan-Abad square, Tehran Tehran Tehran Iran (Islamic Republic of)