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

1. participation in any other clinical trial of an experimental treatment for covid-19 2. clinical signs indicative of severe or critical illness severity * severe: * any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress * clinically suggestive of severe illness with covid-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (spo2) ≤ 93% on room air at sea level, or pao2/fio2 \< 300 * critical illness (one of the following): * respiratory failure defined based on resource utilization requiring at least one of the following: 1. endotracheal intubation and mechanical ventilation, oxygen delivered by high483 flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5) 2. noninvasive positive pressure ventilation, 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) * shock (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg or requiring vasopressors) * multi-organ dysfunction/failure 3. have a history of a positive sars-cov-2 serology test 4. evidence of shock (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg or requiring vasopressors) 5. patients who are hospitalized due to covid-19 6. patients who required oxygen therapy due to covid-19 7. patients who required mechanical ventilation or anticipated impending need for mechanical ventilation 8. receiving v-v ecmo ≥ 5 days, or any duration of v-a ecmo 9. have a history of convalescent covid-19 plasma treatment 10. women who are pregnant or breastfeeding 11. male or female of childbearing potential who has plans to become pregnant during the study period and for six months after the clinical study or who is not willing to take appropriate contraceptive measures (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) 12. viral disease (hiv, hbv, hcv, etc.) other than covid-19 that are not adequately controlled or require administration of other antiviral agents or medications that could potentially interact with tb006 13. patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance

1. participation in any other clinical trial of an experimental treatment for covid-19 2. clinical signs indicative of severe or critical illness severity * severe: * any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress * clinically suggestive of severe illness with covid-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (spo2) ≤ 93% on room air at sea level, or pao2/fio2 \< 300 * critical illness (one of the following): * respiratory failure defined based on resource utilization requiring at least one of the following: 1. endotracheal intubation and mechanical ventilation, oxygen delivered by high483 flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5) 2. noninvasive positive pressure ventilation, 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) * shock (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg or requiring vasopressors) * multi-organ dysfunction/failure 3. have a history of a positive sars-cov-2 serology test 4. evidence of shock (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg or requiring vasopressors) 5. patients who are hospitalized due to covid-19 6. patients who required oxygen therapy due to covid-19 7. patients who required mechanical ventilation or anticipated impending need for mechanical ventilation 8. receiving v-v ecmo ≥ 5 days, or any duration of v-a ecmo 9. have a history of convalescent covid-19 plasma treatment 10. women who are pregnant or breastfeeding 11. male or female of childbearing potential who has plans to become pregnant during the study period and for six months after the clinical study or who is not willing to take appropriate contraceptive measures (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) 12. viral disease (hiv, hbv, hcv, etc.) other than covid-19 that are not adequately controlled or require administration of other antiviral agents or medications that could potentially interact with tb006 13. patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance

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

participation in any other clinical trial of an experimental treatment for covid-19 clinical signs indicative of severe or critical illness severity severe: any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress clinically suggestive of severe illness with covid-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (spo2) ≤ 93% on room air at sea level, or pao2/fio2 < 300 critical illness (one of the following): respiratory failure defined based on resource utilization requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high483 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, 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) shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) multi-organ dysfunction/failure have a history of a positive sars-cov-2 serology test evidence of shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) patients who are hospitalized due to covid-19 patients who required oxygen therapy due to covid-19 patients who required mechanical ventilation or anticipated impending need for mechanical ventilation receiving v-v ecmo ≥ 5 days, or any duration of v-a ecmo have a history of convalescent covid-19 plasma treatment women who are pregnant or breastfeeding male or female of childbearing potential who has plans to become pregnant during the study period and for six months after the clinical study or who is not willing to take appropriate contraceptive measures (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) viral disease (hiv, hbv, hcv, etc.) other than covid-19 that are not adequately controlled or require administration of other antiviral agents or medications that could potentially interact with tb006 patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance

participation in any other clinical trial of an experimental treatment for covid-19 clinical signs indicative of severe or critical illness severity severe: any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress clinically suggestive of severe illness with covid-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (spo2) ≤ 93% on room air at sea level, or pao2/fio2 < 300 critical illness (one of the following): respiratory failure defined based on resource utilization requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high483 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, 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) shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) multi-organ dysfunction/failure have a history of a positive sars-cov-2 serology test evidence of shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) patients who are hospitalized due to covid-19 patients who required oxygen therapy due to covid-19 patients who required mechanical ventilation or anticipated impending need for mechanical ventilation receiving v-v ecmo ≥ 5 days, or any duration of v-a ecmo have a history of convalescent covid-19 plasma treatment women who are pregnant or breastfeeding male or female of childbearing potential who has plans to become pregnant during the study period and for six months after the clinical study or who is not willing to take appropriate contraceptive measures (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) viral disease (hiv, hbv, hcv, etc.) other than covid-19 that are not adequately controlled or require administration of other antiviral agents or medications that could potentially interact with tb006 patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance

March 18, 2021, 12:31 a.m. usa

1. participation in any other clinical trial of an experimental treatment for covid-19 2. clinical signs indicative of severe or critical illness severity - severe: - any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress - clinically suggestive of severe illness with covid-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (spo2) ≤ 93% on room air at sea level, or pao2/fio2 < 300 - critical illness (one of the following): - respiratory failure defined based on resource utilization requiring at least one of the following: 1. endotracheal intubation and mechanical ventilation, oxygen delivered by high483 flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) 2. noninvasive positive pressure ventilation, 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) - shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) - multi-organ dysfunction/failure 3. have a history of a positive sars-cov-2 serology test 4. evidence of shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) 5. patients who are hospitalized due to covid-19 6. patients who required oxygen therapy due to covid-19 7. patients who required mechanical ventilation or anticipated impending need for mechanical ventilation 8. receiving v-v ecmo ≥ 5 days, or any duration of v-a ecmo 9. have a history of convalescent covid-19 plasma treatment 10. women who are pregnant or breastfeeding 11. male or female of childbearing potential who has plans to become pregnant during the study period and for six months after the clinical study or who is not willing to take appropriate contraceptive measures (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) 12. viral disease (hiv, hbv, hcv, etc.) other than covid-19 that are not adequately controlled or require administration of other antiviral agents or medications that could potentially interact with tb006 13. patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance

1. participation in any other clinical trial of an experimental treatment for covid-19 2. clinical signs indicative of severe or critical illness severity - severe: - any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress - clinically suggestive of severe illness with covid-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (spo2) ≤ 93% on room air at sea level, or pao2/fio2 < 300 - critical illness (one of the following): - respiratory failure defined based on resource utilization requiring at least one of the following: 1. endotracheal intubation and mechanical ventilation, oxygen delivered by high483 flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) 2. noninvasive positive pressure ventilation, 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) - shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) - multi-organ dysfunction/failure 3. have a history of a positive sars-cov-2 serology test 4. evidence of shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) 5. patients who are hospitalized due to covid-19 6. patients who required oxygen therapy due to covid-19 7. patients who required mechanical ventilation or anticipated impending need for mechanical ventilation 8. receiving v-v ecmo ≥ 5 days, or any duration of v-a ecmo 9. have a history of convalescent covid-19 plasma treatment 10. women who are pregnant or breastfeeding 11. male or female of childbearing potential who has plans to become pregnant during the study period and for six months after the clinical study or who is not willing to take appropriate contraceptive measures (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) 12. viral disease (hiv, hbv, hcv, etc.) other than covid-19 that are not adequately controlled or require administration of other antiviral agents or medications that could potentially interact with tb006 13. patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance