Created at Source Raw Value Validated value
July 7, 2022, 1:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "gamma-Globulins;Immunoglobulins;Infusions; Intravenous;Anti-SARS-COV-2 gamma globulin;Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 537, "treatment_name": "Gammaglobulin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

June 23, 2022, 2 p.m. oms

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[{"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 537, "treatment_name": "Gammaglobulin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "no third arm", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

June 17, 2022, 12:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Anti-SARS-COV-2 gamma globulin;Infusions; Intravenous;Immunoglobulins;gamma-Globulins;Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 99, "treatment_name": "Anti-sars-cov-2 gamma globulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

March 17, 2022, 5 p.m. oms

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[{"arm_notes": "", "treatment_id": 99, "treatment_name": "Anti-sars-cov-2 gamma globulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

March 11, 2022, 3:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Anti-SARS-COV-2 gamma globulin;Infusions; Intravenous;Immunoglobulins;gamma-Globulins;Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 99, "treatment_name": "Anti-sars-cov-2 gamma globulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

July 16, 2021, 2 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).;gamma-Globulins;Immunoglobulins;Infusions; Intravenous;Anti-SARS-COV-2 gamma globulin", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab); for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin; a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume); slow drip initially (20 drops/min) and after 15 min; move to a faster drip; infusing the product in a period of no less than 2 hours; (intravenous route).;gamma-Globulins;Immunoglobulins;Infusions; Intravenous;Anti-SARS-COV-2 gamma globulin", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]