Created at Source Raw Value Validated value
June 25, 2024, noon usa

* have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: 1. g6pd deficiency 2. breastfeeding 3. psychotic disorder or current psychotic symptoms 4. known hypersensitivity reaction to tq * evidence of severe or critical illness, defined by at least one of the following: 1. clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air 2. respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure \< 90 mmhg, or diastolic blood pressure \<60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure * any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration * receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation * any excluded concomitant medication as described in the arakoda package insert \[section 16.1\]. receipt of a covid-19 vaccine is not exclusionary. * any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment * positive pregnancy test * have been symptomatic for more than seven days when the first dose would be administered

* have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: 1. g6pd deficiency 2. breastfeeding 3. psychotic disorder or current psychotic symptoms 4. known hypersensitivity reaction to tq * evidence of severe or critical illness, defined by at least one of the following: 1. clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air 2. respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure \< 90 mmhg, or diastolic blood pressure \<60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure * any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration * receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation * any excluded concomitant medication as described in the arakoda package insert \[section 16.1\]. receipt of a covid-19 vaccine is not exclusionary. * any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment * positive pregnancy test * have been symptomatic for more than seven days when the first dose would be administered

Nov. 16, 2021, 6:30 p.m. usa

have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: g6pd deficiency breastfeeding psychotic disorder or current psychotic symptoms known hypersensitivity reaction to tq evidence of severe or critical illness, defined by at least one of the following: clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mmhg, or diastolic blood pressure <60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation any excluded concomitant medication as described in the arakoda package insert [section 16.1]. receipt of a covid-19 vaccine is not exclusionary. any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment positive pregnancy test have been symptomatic for more than seven days when the first dose would be administered

have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: g6pd deficiency breastfeeding psychotic disorder or current psychotic symptoms known hypersensitivity reaction to tq evidence of severe or critical illness, defined by at least one of the following: clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mmhg, or diastolic blood pressure <60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation any excluded concomitant medication as described in the arakoda package insert [section 16.1]. receipt of a covid-19 vaccine is not exclusionary. any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment positive pregnancy test have been symptomatic for more than seven days when the first dose would be administered

Oct. 8, 2021, 12:30 p.m. usa

- have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: 1. g6pd deficiency 2. breastfeeding 3. psychotic disorder or current psychotic symptoms 4. known hypersensitivity reaction to tq - evidence of severe or critical illness, defined by at least one of the following: 1. clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air 2. respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mmhg, or diastolic blood pressure <60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure - any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration - receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation - any excluded concomitant medication as described in the arakoda package insert [section 16.1]. receipt of a covid-19 vaccine is not exclusionary. - any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment - positive pregnancy test - have been symptomatic for more than seven days when the first dose would be administered

- have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: 1. g6pd deficiency 2. breastfeeding 3. psychotic disorder or current psychotic symptoms 4. known hypersensitivity reaction to tq - evidence of severe or critical illness, defined by at least one of the following: 1. clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air 2. respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mmhg, or diastolic blood pressure <60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure - any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration - receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation - any excluded concomitant medication as described in the arakoda package insert [section 16.1]. receipt of a covid-19 vaccine is not exclusionary. - any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment - positive pregnancy test - have been symptomatic for more than seven days when the first dose would be administered

Oct. 26, 2020, 11:31 p.m. usa

- have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: 1. g6pd deficiency 2. breastfeeding 3. psychotic disorder or current psychotic symptoms 4. known hypersensitivity reaction to tq - evidence of severe or critical illness, defined by at least one of the following: 1. clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air 2. respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mmhg, or diastolic blood pressure <60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure - any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration - receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation - any excluded concomitant medication as described in the arakoda package insert [section 16.1] - any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment - positive pregnancy test - have been symptomatic for more than five days when the first dose would be administered

- have one of the contraindications for arakoda or kodatef in the prescribing information (section 16.1) including: 1. g6pd deficiency 2. breastfeeding 3. psychotic disorder or current psychotic symptoms 4. known hypersensitivity reaction to tq - evidence of severe or critical illness, defined by at least one of the following: 1. clinical signs indicative of severe systemic illness with covid-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, spo2 ≤93% on room air 2. respiratory failure defined based on resource utilization requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mmhg, or diastolic blood pressure <60 mmhg or requiring vasopressors) iii. multi-organ dysfunction/failure - any other clinically significant acute illness unrelated to covid-19 within seven days prior to first study drug administration - receipt of any experimental treatment for covid-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation - any excluded concomitant medication as described in the arakoda package insert [section 16.1] - any covid-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment - positive pregnancy test - have been symptomatic for more than five days when the first dose would be administered