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

is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. requires more than 6 liters/minute of oxygen to maintain o2 saturation above 95% is not expected to survive longer than 24 hours. has a platelet count less than 100,000/µl, hemoglobin less than 9 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. women who are pregnant or breastfeeding. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. has received a vaccine for covid-19 prior to enrollment, or plans to receive a vaccine for covid-19 before the end-of-study visit. has received an experimental antiviral treatment for covid-19 prior to enrollment. has received convalescent plasma or other monoclonal antibodies prior to enrollment.. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <30 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to covid-19 symptom onset requiring bilevel positive airway pressure (bipap) or >4 l/min supplemental oxygen at baseline; if using ≤4 l/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment. has a diagnosis of cancer that is not in remission. noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor. has received an organ transplantation. has received a bone marrow transplantation. has been on immunosuppressive medications within one month prior to enrollment. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. is currently taking systemic corticosteroids other than replacement doses, or for treatment of covid-19. has a body mass index (bmi) >50 kg/m2. is anticipated to require surgery within 48 hours after hospital admission. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. requires more than 6 liters/minute of oxygen to maintain o2 saturation above 95% is not expected to survive longer than 24 hours. has a platelet count less than 100,000/µl, hemoglobin less than 9 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. women who are pregnant or breastfeeding. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. has received a vaccine for covid-19 prior to enrollment, or plans to receive a vaccine for covid-19 before the end-of-study visit. has received an experimental antiviral treatment for covid-19 prior to enrollment. has received convalescent plasma or other monoclonal antibodies prior to enrollment.. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <30 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to covid-19 symptom onset requiring bilevel positive airway pressure (bipap) or >4 l/min supplemental oxygen at baseline; if using ≤4 l/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment. has a diagnosis of cancer that is not in remission. noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor. has received an organ transplantation. has received a bone marrow transplantation. has been on immunosuppressive medications within one month prior to enrollment. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. is currently taking systemic corticosteroids other than replacement doses, or for treatment of covid-19. has a body mass index (bmi) >50 kg/m2. is anticipated to require surgery within 48 hours after hospital admission. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

May 22, 2021, 12:32 a.m. usa

1. is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. 2. requires more than 6 liters/minute of oxygen to maintain o2 saturation above 95% 3. is not expected to survive longer than 24 hours. 4. has a platelet count less than 100,000/µl, hemoglobin less than 9 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. 5. women who are pregnant or breastfeeding. 6. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 7. has received a vaccine for covid-19 prior to enrollment, or plans to receive a vaccine for covid-19 before the end-of-study visit. 8. has received an experimental antiviral treatment for covid-19 prior to enrollment. 9. has received convalescent plasma or other monoclonal antibodies prior to enrollment.. 10. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). 11. in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <30 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to covid-19 symptom onset requiring bilevel positive airway pressure (bipap) or >4 l/min supplemental oxygen at baseline; if using ≤4 l/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment. 12. has a diagnosis of cancer that is not in remission. noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor. 13. has received an organ transplantation. 14. has received a bone marrow transplantation. 15. has been on immunosuppressive medications within one month prior to enrollment. 16. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 17. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. 18. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. 19. is currently taking systemic corticosteroids other than replacement doses, or for treatment of covid-19. 20. has a body mass index (bmi) >50 kg/m2. 21. is anticipated to require surgery within 48 hours after hospital admission. 22. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

1. is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. 2. requires more than 6 liters/minute of oxygen to maintain o2 saturation above 95% 3. is not expected to survive longer than 24 hours. 4. has a platelet count less than 100,000/µl, hemoglobin less than 9 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. 5. women who are pregnant or breastfeeding. 6. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 7. has received a vaccine for covid-19 prior to enrollment, or plans to receive a vaccine for covid-19 before the end-of-study visit. 8. has received an experimental antiviral treatment for covid-19 prior to enrollment. 9. has received convalescent plasma or other monoclonal antibodies prior to enrollment.. 10. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). 11. in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <30 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to covid-19 symptom onset requiring bilevel positive airway pressure (bipap) or >4 l/min supplemental oxygen at baseline; if using ≤4 l/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment. 12. has a diagnosis of cancer that is not in remission. noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor. 13. has received an organ transplantation. 14. has received a bone marrow transplantation. 15. has been on immunosuppressive medications within one month prior to enrollment. 16. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 17. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. 18. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. 19. is currently taking systemic corticosteroids other than replacement doses, or for treatment of covid-19. 20. has a body mass index (bmi) >50 kg/m2. 21. is anticipated to require surgery within 48 hours after hospital admission. 22. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

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

1. has an illness within the past 30 days that requires mechanical ventilation prior to enrollment. 2. is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. 3. requires more than 6 liters/minute of oxygen to maintain o2 saturation above 95% 4. is not expected to survive longer than 24 hours. 5. has a platelet count less than 100,000/µl, hemoglobin less than 10 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. 6. women who are pregnant or breastfeeding. 7. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 8. has received an experimental vaccine for covid-19 prior to the first dose of study drug 9. has received hydroxychloroquine or chloroquine within 30 days of study enrollment. 10. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). 11. in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <30 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to covid-19 symptom onset requiring bilevel positive airway pressure (bipap) or >2 l/min supplemental oxygen at baseline; if using ≤2 l/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment. 12. has a diagnosis of cancer that is not in remission. noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor. 13. has received an organ transplantation. 14. has received a bone marrow transplantation. 15. has been on immunosuppressive medications within one month prior to enrollment. 16. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 17. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. 18. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. 19. is currently taking systemic corticosteroids other than replacement doses, or for treatment of covid-19. 20. has a body mass index (bmi) >50 kg/m2. 21. is anticipated to require surgery within 48 hours after hospital admission. 22. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

1. has an illness within the past 30 days that requires mechanical ventilation prior to enrollment. 2. is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. 3. requires more than 6 liters/minute of oxygen to maintain o2 saturation above 95% 4. is not expected to survive longer than 24 hours. 5. has a platelet count less than 100,000/µl, hemoglobin less than 10 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. 6. women who are pregnant or breastfeeding. 7. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 8. has received an experimental vaccine for covid-19 prior to the first dose of study drug 9. has received hydroxychloroquine or chloroquine within 30 days of study enrollment. 10. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). 11. in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <30 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to covid-19 symptom onset requiring bilevel positive airway pressure (bipap) or >2 l/min supplemental oxygen at baseline; if using ≤2 l/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment. 12. has a diagnosis of cancer that is not in remission. noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor. 13. has received an organ transplantation. 14. has received a bone marrow transplantation. 15. has been on immunosuppressive medications within one month prior to enrollment. 16. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 17. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. 18. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. 19. is currently taking systemic corticosteroids other than replacement doses, or for treatment of covid-19. 20. has a body mass index (bmi) >50 kg/m2. 21. is anticipated to require surgery within 48 hours after hospital admission. 22. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

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

1. has an illness within the past 30 days that requires mechanical ventilation prior to enrollment. 2. is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. 3. is not expected to survive longer than 24 hours. 4. has a platelet count less than 100,000/µl, hemoglobin less than 10 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. 5. women who are pregnant or breastfeeding. 6. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 7. has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days for the treatment or prophylaxis of covid-19 prior to the first dose of study drug. 8. has received hydroxychloroquine or chloroquine within 30 days of study enrollment. 9. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). 10. in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <60 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease requiring baseline supplemental oxygen, or bilevel positive airway pressure (bipap) prior to covid-19 symptom onset. 11. has a diagnosis of cancer that is not in remission. 12. has received an organ transplantation. 13. has received a bone marrow transplantation. 14. has been on immunosuppressive medications within one month prior to enrollment. 15. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 16. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. 17. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. 18. is currently taking systemic corticosteroids other than replacement doses. 19. nasal septal deviations, structural defects or corrective surgeries to prevent obtaining bilateral np swabs in the posterior nasopharynx. 20. has a body mass index (bmi) >45 kg/m2. 21. is anticipated to require surgery within 48 hours after hospital admission. 22. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.

1. has an illness within the past 30 days that requires mechanical ventilation prior to enrollment. 2. is anticipated to require icu admission for mechanical ventilation within 24 hours of enrollment. 3. is not expected to survive longer than 24 hours. 4. has a platelet count less than 100,000/µl, hemoglobin less than 10 g/dl, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease. 5. women who are pregnant or breastfeeding. 6. is experiencing daids ae grading scale grade 4 baseline medical conditions or laboratory abnormalities.. 7. has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days for the treatment or prophylaxis of covid-19 prior to the first dose of study drug. 8. has received hydroxychloroquine or chloroquine within 30 days of study enrollment. 9. is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted). 10. in the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (gfr) <60 ml/min by the modification of diet in renal disease (mdrd) study equation prior to covid-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease requiring baseline supplemental oxygen, or bilevel positive airway pressure (bipap) prior to covid-19 symptom onset. 11. has a diagnosis of cancer that is not in remission. 12. has received an organ transplantation. 13. has received a bone marrow transplantation. 14. has been on immunosuppressive medications within one month prior to enrollment. 15. has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial. 16. has known active hepatitis c (hcv rna positive), active hepatitis b (hepatitis b surface antigen positive), or hiv (elisa and confirmatory western blotting). new screening tests not required. 17. is currently taking nucleos(t)ide analogues for hiv or hepatitis b, or for their prevention, within 30 days of study enrollment. 18. is currently taking systemic corticosteroids other than replacement doses. 19. nasal septal deviations, structural defects or corrective surgeries to prevent obtaining bilateral np swabs in the posterior nasopharynx. 20. has a body mass index (bmi) >45 kg/m2. 21. is anticipated to require surgery within 48 hours after hospital admission. 22. is anticipated to have a nothing per mouth (npo) order placed within 48 hours after hospital admission that is expected to last for > 24 hours.