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

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Group name:placebo-controlled study to evaluate the efficacy and safety of mavrilimumab (KPL-301) treatment in adult subjects hospitalized with severe COVID-19 pneumonia and hyper-inflammation Type of group;1 N\u00b0 of participants:573 Intervention(s) description:Mavrilimumab (KPL-301; formerly known as CAM-3001) is a recombinant human monoclonal immunoglobulin G (IgG)4 antibody; which modulates activity of granulocyte-macrophage colony-stimulating factor (GM-CSF) by binding to the alpha subunit of its receptor (GMCSFRα).\t\t\t\tMavrilimumab is a sterile; clear to opalescent; colorless to slightly brown-yellow liquid; free from visible particles and is formulated at 150 mg/mL in 50 mM sodium acetate; 70 mM sodium chloride; 4% weight/volume trehalose dihydrate; 0.05% weight/volume polysorbate 80 with a pH of 5.8. It is supplied by Kiniksa Pharmaceuticals as a liquid in accessorized pre-filled syringes or in vials for parenteral administration. Please see the Pharmacy Manual for additional details Subjects will receive a single IV infusion of either 10 mg/kg or 6 mg/kg mavrilimumab or placebo over approximately 60 minutes. Total dose may not exceed 1000 mg; which was approximately the maximum dose administered in the Phase 1 study with IV infusion. Dosing will be based on body weight obtained at Screening. Additional details regarding mavrilimumab", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 771, "treatment_name": "Mavrilimumab", "treatment_type": "Monoclonal antibodies", "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

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

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Group name:placebo-controlled study to evaluate the efficacy and safety of mavrilimumab (KPL-301) treatment in adult subjects hospitalized with severe COVID-19 pneumonia and hyper-inflammation Type of group;1 N\u00b0 of participants:573 Intervention(s) description:Mavrilimumab (KPL-301; formerly known as CAM-3001) is a recombinant human monoclonal immunoglobulin G (IgG)4 antibody; which modulates activity of granulocyte-macrophage colony-stimulating factor (GM-CSF) by binding to the alpha subunit of its receptor (GMCSFRα).Mavrilimumab is a sterile; clear to opalescent; colorless to slightly brown-yellow liquid; free from visible particles and is formulated at 150 mg/mL in 50 mM sodium acetate; 70 mM sodium chloride; 4% weight/volume trehalose dihydrate; 0.05% weight/volume polysorbate 80 with a pH of 5.8. It is supplied by Kiniksa Pharmaceuticals as a liquid in accessorized pre-filled syringes or in vials for parenteral administration. Please see the Pharmacy Manual for additional details Subjects will receive a single IV infusion of either 10 mg/kg or 6 mg/kg mavrilimumab or placebo over approximately 60 minutes. Total dose may not exceed 1000 mg; which was approximately the maximum dose administered in the Phase 1 study with IV infusion. Dosing will be based on body weight obtained at Screening. Additional details regarding mavrilimumab", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]