Created at Source Raw Value Validated value
July 30, 2021, 1:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a Phase I/IIa; double-blind; placebo-controlled study which is subdivided into 4 parts. Parts A-C will be conducted in healthy adult participants and Part D will be conducted in hospitalised COVID-19 patients with moderate illness.Part A (Cohorts 1-4) will be conducted as a single ascending dose (SAD) study; whereby healthy volunteers will be enrolled to receive a single dose of inhaled enoxaparin (or placebo). Three dose levels of inhaled enoxaparin will be explored in Part A (0.25; 0.5; 1 or 2 mg/kg/dose). Sentinel dosing will be employed for all dose level cohorts for Part A.Part B (Cohorts 5-6) will be conducted as a multiple ascending dose (MAD) study; whereby healthy volunteers will be enrolled to receive multiple doses of inhaled enoxaparin (or placebo) every 12 hours (q12h) for 7 days. Two dose levels of inhaled enoxaparin will be explored in Part B (0.5 or 1 mg/kg/dose).In Part C (Cohorts 7-8); healthy volunteers will be enrolled to receive MADs of inhaled enoxaparin (or placebo) in combination with fixed doses of inhaled N-acetylcysteine. Two dose levels of inhaled enoxaparin will be explored in Part C (0.5 or 1 mg/kg/dose). Each dose of inhaled N-acetylcysteine will be 600 mg.Sentinel dosing will be employed for all dose level cohorts for Part C.Dosing in part C is as follows:\u2022\tParticipants will receive a single dose of inhaled N-acetylcysteine on study Day 1. \u2022\tParticipants will receive a single dose of inhaled enoxaparin (or placebo) on study Day 2.\u2022\tParticipants will receive a single dose each of inhaled enoxaparin (or placebo) and inhaled N-acetylcysteine on study Day 3.\u2022\tParticipants will receive inhaled enoxaparin (or placebo) q12h plus inhaled N-acetylcysteine every 6 hours (q6h) for 7 days starting on s", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "Part A single dose: (0.25; 0.5; 1 or 2 mg/kg/dose)", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Part B multiple dose: (0.5 or 1 mg/kg/dose)", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Part C multiple dose: (0.5 or 1 mg/kg/dose) + N-acetylcysteine 600 mg", "treatment_id": 2202, "treatment_name": "Enoxaparin+n-acetylcysteine", "treatment_type": "Coagulation modifiers+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Part D : dose based on safety and tolerability data obtained in Part C + N-acetylcysteine 600 mg", "treatment_id": 2202, "treatment_name": "Enoxaparin+n-acetylcysteine", "treatment_type": "Coagulation modifiers+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]

July 23, 2021, 11 p.m. oms

[]

June 17, 2021, 12:45 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a Phase I/IIa; double-blind; placebo-controlled study which is subdivided into 4 parts. Parts A-C will be conducted in healthy adult participants and Part D will be conducted in hospitalised COVID-19 patients with moderate illness.Part A (Cohorts 1-4) will be conducted as a single ascending dose (SAD) study; whereby healthy volunteers will be enrolled to receive a single dose of inhaled enoxaparin (or placebo). Three dose levels of inhaled enoxaparin will be explored in Part A (0.25; 0.5; 1 or 2 mg/kg/dose). Sentinel dosing will be employed for all dose level cohorts for Part A.Part B (Cohorts 5-6) will be conducted as a multiple ascending dose (MAD) study; whereby healthy volunteers will be enrolled to receive multiple doses of inhaled enoxaparin (or placebo) every 12 hours (q12h) for 7 days. Two dose levels of inhaled enoxaparin will be explored in Part B (0.5 or 1 mg/kg/dose).In Part C (Cohorts 7-8); healthy volunteers will be enrolled to receive MADs of inhaled enoxaparin (or placebo) in combination with fixed doses of inhaled N-acetylcysteine. Two dose levels of inhaled enoxaparin will be explored in Part C (0.5 or 1 mg/kg/dose). Each dose of inhaled N-acetylcysteine will be 600 mg.Sentinel dosing will be employed for all dose level cohorts for Part C.Dosing in part C is as follows:\u2022\tParticipants will receive a single dose of inhaled N-acetylcysteine on study Day 1. \u2022\tParticipants will receive a single dose of inhaled enoxaparin (or placebo) on study Day 2.\u2022\tParticipants will receive a single dose each of inhaled enoxaparin (or placebo) and inhaled N-acetylcysteine on study Day 3.\u2022\tParticipants will receive inhaled enoxaparin (or placebo) q12h plus inhaled N-acetylcysteine every 6 hours (q6h) for 7 days starting on s", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]