Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

any co-morbidity that may add risk to the treatment in the judgement of the investigator. requiring intubation and mechanical ventilation patient having a do not intubate or do not resuscitate order oxygen saturation >95% on room air any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization patient is, in the investigator's clinical judgment, unlikely to survive >72 hours pregnant or nursing women unwillingness or inability to comply with procedures required in this protocol. corrected qt (qtc) interval on electrocardiogram (ecg) >470 ms for females or >450 ms for males, calculated using friedericia's formula (qtcf) ast (sgot) or alt (sgpt) > 2.5 x upper limit of normal (uln) bilirubin >2.0 x uln (except where bilirubin increase is due to gilbert's syndrome) serum creatinine >2.0 x uln absolute neutrophil count <1000 cells/mm3 platelet count <75,000/mm3 hemoglobin <8.0 g/dl currently taking medications that are sensitive cyp3a4, cyp1a2, cyp2c9, or cyp2c19 or cyp2d6 substrates and have a narrow therapeutic index. these should be decided in discussion with the medical monitor on a case-by-case basis. currently taking medications that are strong inducers or inhibitors of cyp2d6 and cyp3a4. these should be decided in discussion with the medical monitor on a case-by-case basis. currently taking warfarin, apixaban, argatroban or rivaroxaban. current drug or alcohol abuse. currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies.

any co-morbidity that may add risk to the treatment in the judgement of the investigator. requiring intubation and mechanical ventilation patient having a do not intubate or do not resuscitate order oxygen saturation >95% on room air any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization patient is, in the investigator's clinical judgment, unlikely to survive >72 hours pregnant or nursing women unwillingness or inability to comply with procedures required in this protocol. corrected qt (qtc) interval on electrocardiogram (ecg) >470 ms for females or >450 ms for males, calculated using friedericia's formula (qtcf) ast (sgot) or alt (sgpt) > 2.5 x upper limit of normal (uln) bilirubin >2.0 x uln (except where bilirubin increase is due to gilbert's syndrome) serum creatinine >2.0 x uln absolute neutrophil count <1000 cells/mm3 platelet count <75,000/mm3 hemoglobin <8.0 g/dl currently taking medications that are sensitive cyp3a4, cyp1a2, cyp2c9, or cyp2c19 or cyp2d6 substrates and have a narrow therapeutic index. these should be decided in discussion with the medical monitor on a case-by-case basis. currently taking medications that are strong inducers or inhibitors of cyp2d6 and cyp3a4. these should be decided in discussion with the medical monitor on a case-by-case basis. currently taking warfarin, apixaban, argatroban or rivaroxaban. current drug or alcohol abuse. currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies.

Dec. 21, 2020, 12:31 a.m. usa

1. any co-morbidity that may add risk to the treatment in the judgement of the investigator. 2. requiring intubation and mechanical ventilation 3. patient having a do not intubate or do not resuscitate order 4. oxygen saturation >95% on room air 5. any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization 6. patient is, in the investigator's clinical judgment, unlikely to survive >72 hours 7. pregnant or nursing women 8. unwillingness or inability to comply with procedures required in this protocol. 9. corrected qt (qtc) interval on electrocardiogram (ecg) >470 ms for females or >450 ms for males, calculated using friedericia's formula (qtcf) 10. ast (sgot) or alt (sgpt) > 2.5 x upper limit of normal (uln) 11. bilirubin >2.0 x uln (except where bilirubin increase is due to gilbert's syndrome) 12. serum creatinine >2.0 x uln 13. absolute neutrophil count <1000 cells/mm3 14. platelet count <75,000/mm3 15. hemoglobin <8.0 g/dl 16. currently taking medications that are sensitive cyp3a4, cyp1a2, cyp2c9, or cyp2c19 or cyp2d6 substrates and have a narrow therapeutic index. these should be decided in discussion with the medical monitor on a case-by-case basis. 17. currently taking medications that are strong inducers or inhibitors of cyp2d6 and cyp3a4. these should be decided in discussion with the medical monitor on a case-by-case basis. 18. currently taking warfarin, apixaban, argatroban or rivaroxaban. 19. current drug or alcohol abuse. 20. currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies.

1. any co-morbidity that may add risk to the treatment in the judgement of the investigator. 2. requiring intubation and mechanical ventilation 3. patient having a do not intubate or do not resuscitate order 4. oxygen saturation >95% on room air 5. any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization 6. patient is, in the investigator's clinical judgment, unlikely to survive >72 hours 7. pregnant or nursing women 8. unwillingness or inability to comply with procedures required in this protocol. 9. corrected qt (qtc) interval on electrocardiogram (ecg) >470 ms for females or >450 ms for males, calculated using friedericia's formula (qtcf) 10. ast (sgot) or alt (sgpt) > 2.5 x upper limit of normal (uln) 11. bilirubin >2.0 x uln (except where bilirubin increase is due to gilbert's syndrome) 12. serum creatinine >2.0 x uln 13. absolute neutrophil count <1000 cells/mm3 14. platelet count <75,000/mm3 15. hemoglobin <8.0 g/dl 16. currently taking medications that are sensitive cyp3a4, cyp1a2, cyp2c9, or cyp2c19 or cyp2d6 substrates and have a narrow therapeutic index. these should be decided in discussion with the medical monitor on a case-by-case basis. 17. currently taking medications that are strong inducers or inhibitors of cyp2d6 and cyp3a4. these should be decided in discussion with the medical monitor on a case-by-case basis. 18. currently taking warfarin, apixaban, argatroban or rivaroxaban. 19. current drug or alcohol abuse. 20. currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies.

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

1. any co-morbidity that may add risk to the treatment in the judgement of the investigator. 2. requiring intubation and mechanical ventilation 3. oxygen saturation >95% on room air 4. any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization 5. patient is, in the investigator's clinical judgment, unlikely to survive >72 hours 6. pregnant or nursing women 7. unwillingness or inability to comply with procedures required in this protocol. 8. corrected qt (qtc) interval on electrocardiogram (ecg) >470 ms for females or >450 ms for males, calculated using friedericia's formula (qtcf) 9. ast (sgot) or alt (sgpt) > 2.5 x upper limit of normal (uln) 10. bilirubin >1.5x uln (except where bilirubin increase is due to gilbert's syndrome) 11. serum creatinine >2.0 x uln 12. absolute neutrophil count <1000 cells/mm3 13. platelet count <75,000/mm3 14. hemoglobin <8.0 g/dl 15. currently taking medications that are sensitive cyp3a4, cyp2c9 or cyp2c19 substrates and have a narrow therapeutic index 16. currently taking medications that are strong inducers or inhibitors of cyp2d6 and cyp3a4 17. currently taking warfarin, apixaban, argatroban or rivaroxaban 18. current drug or alcohol abuse 19. currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies

1. any co-morbidity that may add risk to the treatment in the judgement of the investigator. 2. requiring intubation and mechanical ventilation 3. oxygen saturation >95% on room air 4. any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization 5. patient is, in the investigator's clinical judgment, unlikely to survive >72 hours 6. pregnant or nursing women 7. unwillingness or inability to comply with procedures required in this protocol. 8. corrected qt (qtc) interval on electrocardiogram (ecg) >470 ms for females or >450 ms for males, calculated using friedericia's formula (qtcf) 9. ast (sgot) or alt (sgpt) > 2.5 x upper limit of normal (uln) 10. bilirubin >1.5x uln (except where bilirubin increase is due to gilbert's syndrome) 11. serum creatinine >2.0 x uln 12. absolute neutrophil count <1000 cells/mm3 13. platelet count <75,000/mm3 14. hemoglobin <8.0 g/dl 15. currently taking medications that are sensitive cyp3a4, cyp2c9 or cyp2c19 substrates and have a narrow therapeutic index 16. currently taking medications that are strong inducers or inhibitors of cyp2d6 and cyp3a4 17. currently taking warfarin, apixaban, argatroban or rivaroxaban 18. current drug or alcohol abuse 19. currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies