Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: Nafamostat Mesilate Injection 50 mg/ 100 mg vial: Dissolve a daily dose of Nafamostat mesilate in 1000 ml of 5 % dextrose and to be infused at dose of 0.1 mg/kg/hr for 24 hrs by continuous infusion for 10 daysIf the patient meets clinical improvement/ discharge criteria any time prior to completing infusion on Day 10; the treatment can be stopped earlier and subject can be discharged and followed up as defined in protocolAlso; Standard of care as per institutional practice.Patients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.Control Intervention1: Standard of care as per institutional practice: Standard of care as per institutional practicePatients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: Nafamostat Mesilate Injection 50 mg/ 100 mg vial: Dissolve a daily dose of Nafamostat mesilate in 1000 ml of 5 % dextrose and to be infused at dose of 0.1 mg/kg/hr for 24 hrs by continuous infusion for 10 daysIf the patient meets clinical improvement/ discharge criteria any time prior to completing infusion on Day 10; the treatment can be stopped earlier and subject can be discharged and followed up as defined in protocolAlso; Standard of care as per institutional practice.Patients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Control Intervention1: Standard of care as per institutional practice: Standard of care as per institutional practicePatients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 854, "treatment_name": "Nafamostat mesilate", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

Nov. 13, 2021, 5:33 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "N/A", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: Nafamostat Mesilate Injection 50 mg/ 100 mg vial: Dissolve a daily dose of Nafamostat mesilate in 1000 ml of 5 % dextrose and to be infused at dose of 0.1 mg/kg/hr for 24 hrs by continuous infusion for 10 daysIf the patient meets clinical improvement/ discharge criteria any time prior to completing infusion on Day 10; the treatment can be stopped earlier and subject can be discharged and followed up as defined in protocolAlso; Standard of care as per institutional practice.Patients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.Control Intervention1: Standard of care as per institutional practice: Standard of care as per institutional practicePatients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: Nafamostat Mesilate Injection 50 mg/ 100 mg vial: Dissolve a daily dose of Nafamostat mesilate in 1000 ml of 5 % dextrose and to be infused at dose of 0.1 mg/kg/hr for 24 hrs by continuous infusion for 10 daysIf the patient meets clinical improvement/ discharge criteria any time prior to completing infusion on Day 10; the treatment can be stopped earlier and subject can be discharged and followed up as defined in protocolAlso; Standard of care as per institutional practice.Patients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Control Intervention1: Standard of care as per institutional practice: Standard of care as per institutional practicePatients may be given prophylactic LMWH (e.g.; Enoxaparin 1mg/kg per day Subcutaneously) as per investigator\u00e2??s discretion. Before starting LMWH; investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]