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

1. subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) 2. subjects with an egfr \< 30 ml/min, at the screening visit 3. prisoners or subjects who are involuntarily incarcerated 4. subjects who are participating in any other investigational clinical trial while participating in this clinical trial 5. subjects who are under the age of 18 years 6. subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to ip administration) 7. subjects with multi-organ failure 8. subjects who have received more than 48 hours of supplemental oxygen prior to randomization 9. subjects with prior significant pulmonary disease (e.g., severe copd/ild/chf/ipf) are excluded 10. subjects receiving investigational therapies as part of a formal clinical trial for the treatment of covid-19. during the course of this study, investigational therapies that may become "standard of care" to treat covid-19, but are not part of a clinical trial, are allowed 11. subjects who are on long-acting cgrp monoclonal antibodies will be excluded including aimovig (erenumab), emgality (galcanezumab), ajovy (fremanezumab), and vyepti (eptinezumab). additionally, the investigational oral cgrp receptor antagonist, atogepant, that is taken daily will also be excluded. oral cgrp receptor antagonists, nurtec odt (rimegepant) and ubelvy (ubrogepant) that are typically used prn infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study 12. subjects who are unlikely to survive for more than 48 hours from the screening visit 13. subjects with any of the following abnormal laboratory values at screening: aspartate ast or alt greater than 5x uln or bilirubin greater than 2x uln 14. subjects with known active tb, history of incompletely treated tb, suspected or known extrapulmonary tb 15. subjects with suspected or known systemic bacterial or fungal infections. however, empiric antibiotics are permitted. 16. subjects who have participated in any clinical research study evaluating an ip or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit 17. subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study

1. subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) 2. subjects with an egfr \< 30 ml/min, at the screening visit 3. prisoners or subjects who are involuntarily incarcerated 4. subjects who are participating in any other investigational clinical trial while participating in this clinical trial 5. subjects who are under the age of 18 years 6. subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to ip administration) 7. subjects with multi-organ failure 8. subjects who have received more than 48 hours of supplemental oxygen prior to randomization 9. subjects with prior significant pulmonary disease (e.g., severe copd/ild/chf/ipf) are excluded 10. subjects receiving investigational therapies as part of a formal clinical trial for the treatment of covid-19. during the course of this study, investigational therapies that may become "standard of care" to treat covid-19, but are not part of a clinical trial, are allowed 11. subjects who are on long-acting cgrp monoclonal antibodies will be excluded including aimovig (erenumab), emgality (galcanezumab), ajovy (fremanezumab), and vyepti (eptinezumab). additionally, the investigational oral cgrp receptor antagonist, atogepant, that is taken daily will also be excluded. oral cgrp receptor antagonists, nurtec odt (rimegepant) and ubelvy (ubrogepant) that are typically used prn infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study 12. subjects who are unlikely to survive for more than 48 hours from the screening visit 13. subjects with any of the following abnormal laboratory values at screening: aspartate ast or alt greater than 5x uln or bilirubin greater than 2x uln 14. subjects with known active tb, history of incompletely treated tb, suspected or known extrapulmonary tb 15. subjects with suspected or known systemic bacterial or fungal infections. however, empiric antibiotics are permitted. 16. subjects who have participated in any clinical research study evaluating an ip or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit 17. subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study

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

subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) subjects with an egfr < 30 ml/min, at the screening visit prisoners or subjects who are involuntarily incarcerated subjects who are participating in any other investigational clinical trial while participating in this clinical trial subjects who are under the age of 18 years subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to ip administration) subjects with multi-organ failure subjects who have received more than 48 hours of supplemental oxygen prior to randomization subjects with prior significant pulmonary disease (e.g., severe copd/ild/chf/ipf) are excluded subjects receiving investigational therapies as part of a formal clinical trial for the treatment of covid-19. during the course of this study, investigational therapies that may become "standard of care" to treat covid-19, but are not part of a clinical trial, are allowed subjects who are on long-acting cgrp monoclonal antibodies will be excluded including aimovig (erenumab), emgality (galcanezumab), ajovy (fremanezumab), and vyepti (eptinezumab). additionally, the investigational oral cgrp receptor antagonist, atogepant, that is taken daily will also be excluded. oral cgrp receptor antagonists, nurtec odt (rimegepant) and ubelvy (ubrogepant) that are typically used prn infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study subjects who are unlikely to survive for more than 48 hours from the screening visit subjects with any of the following abnormal laboratory values at screening: aspartate ast or alt greater than 5x uln or bilirubin greater than 2x uln subjects with known active tb, history of incompletely treated tb, suspected or known extrapulmonary tb subjects with suspected or known systemic bacterial or fungal infections. however, empiric antibiotics are permitted. subjects who have participated in any clinical research study evaluating an ip or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study

subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) subjects with an egfr < 30 ml/min, at the screening visit prisoners or subjects who are involuntarily incarcerated subjects who are participating in any other investigational clinical trial while participating in this clinical trial subjects who are under the age of 18 years subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to ip administration) subjects with multi-organ failure subjects who have received more than 48 hours of supplemental oxygen prior to randomization subjects with prior significant pulmonary disease (e.g., severe copd/ild/chf/ipf) are excluded subjects receiving investigational therapies as part of a formal clinical trial for the treatment of covid-19. during the course of this study, investigational therapies that may become "standard of care" to treat covid-19, but are not part of a clinical trial, are allowed subjects who are on long-acting cgrp monoclonal antibodies will be excluded including aimovig (erenumab), emgality (galcanezumab), ajovy (fremanezumab), and vyepti (eptinezumab). additionally, the investigational oral cgrp receptor antagonist, atogepant, that is taken daily will also be excluded. oral cgrp receptor antagonists, nurtec odt (rimegepant) and ubelvy (ubrogepant) that are typically used prn infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study subjects who are unlikely to survive for more than 48 hours from the screening visit subjects with any of the following abnormal laboratory values at screening: aspartate ast or alt greater than 5x uln or bilirubin greater than 2x uln subjects with known active tb, history of incompletely treated tb, suspected or known extrapulmonary tb subjects with suspected or known systemic bacterial or fungal infections. however, empiric antibiotics are permitted. subjects who have participated in any clinical research study evaluating an ip or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study

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

1. subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) 2. subjects with an egfr < 30 ml/min, at the screening visit 3. prisoners or subjects who are involuntarily incarcerated 4. subjects who are participating in any other investigational clinical trial while participating in this clinical trial 5. subjects who are under the age of 18 years 6. subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to ip administration) 7. subjects with multi-organ failure 8. subjects who have received more than 48 hours of supplemental oxygen prior to randomization 9. subjects with prior significant pulmonary disease (e.g., severe copd/ild/chf/ipf) are excluded 10. subjects receiving investigational therapies as part of a formal clinical trial for the treatment of covid-19. during the course of this study, investigational therapies that may become "standard of care" to treat covid-19, but are not part of a clinical trial, are allowed 11. subjects who are on long-acting cgrp monoclonal antibodies will be excluded including aimovig (erenumab), emgality (galcanezumab), ajovy (fremanezumab), and vyepti (eptinezumab). additionally, the investigational oral cgrp receptor antagonist, atogepant, that is taken daily will also be excluded. oral cgrp receptor antagonists, nurtec odt (rimegepant) and ubelvy (ubrogepant) that are typically used prn infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study 12. subjects who are unlikely to survive for more than 48 hours from the screening visit 13. subjects with any of the following abnormal laboratory values at screening: aspartate ast or alt greater than 5x uln or bilirubin greater than 2x uln 14. subjects with known active tb, history of incompletely treated tb, suspected or known extrapulmonary tb 15. subjects with suspected or known systemic bacterial or fungal infections. however, empiric antibiotics are permitted. 16. subjects who have participated in any clinical research study evaluating an ip or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit 17. subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study

1. subjects in immediate need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ecmo) 2. subjects with an egfr < 30 ml/min, at the screening visit 3. prisoners or subjects who are involuntarily incarcerated 4. subjects who are participating in any other investigational clinical trial while participating in this clinical trial 5. subjects who are under the age of 18 years 6. subjects who are pregnant (all potential female enrollees need to have a negative pregnancy test prior to ip administration) 7. subjects with multi-organ failure 8. subjects who have received more than 48 hours of supplemental oxygen prior to randomization 9. subjects with prior significant pulmonary disease (e.g., severe copd/ild/chf/ipf) are excluded 10. subjects receiving investigational therapies as part of a formal clinical trial for the treatment of covid-19. during the course of this study, investigational therapies that may become "standard of care" to treat covid-19, but are not part of a clinical trial, are allowed 11. subjects who are on long-acting cgrp monoclonal antibodies will be excluded including aimovig (erenumab), emgality (galcanezumab), ajovy (fremanezumab), and vyepti (eptinezumab). additionally, the investigational oral cgrp receptor antagonist, atogepant, that is taken daily will also be excluded. oral cgrp receptor antagonists, nurtec odt (rimegepant) and ubelvy (ubrogepant) that are typically used prn infrequently will not be excluded as long the subject was not taking them on a daily basis and does not take them during the current study 12. subjects who are unlikely to survive for more than 48 hours from the screening visit 13. subjects with any of the following abnormal laboratory values at screening: aspartate ast or alt greater than 5x uln or bilirubin greater than 2x uln 14. subjects with known active tb, history of incompletely treated tb, suspected or known extrapulmonary tb 15. subjects with suspected or known systemic bacterial or fungal infections. however, empiric antibiotics are permitted. 16. subjects who have participated in any clinical research study evaluating an ip or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit 17. subjects with any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study