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

participation in any other clinical trial of an experimental treatment for covid-19 or participation in another interventional clinical trial, including an expanded access trial. concurrent treatment with other agents with actual or possible direct acting antiviral activity against sars cov 2 infection <24 hours prior to study drug dosing except for remdesivir. uncontrolled hypertension (systolic blood pressure >150 mmhg and/or diastolic blood pressure >100 mmhg), unstable angina, congestive heart failure of any new york respiratory association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment. hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine. renal function impairment (creatinine clearance [cr. cl.] <50 ml/min, based on modification of diet in renal disease calculation). liver function impairment alanine aminotransferase (alt) or aspartate aminotransferase (ast) >5 × upper limit of normal (uln), or alt/ast >3 × uln plus total bilirubin >2 × uln. total bilirubin >1.5 × uln, unless the subject has known gilbert's syndrome. platelet count <50 000/µl multi-organ failure. document active infection with a bacterial pathogen requiring parenteral systemic antibiotics. bacterial or fungal sepsis. history of live vaccination within the last 4 weeks prior to study enrollment; subjects must not receive live, attenuated influenza vaccine (eg, flumist) within 4 weeks before enrolment or at any time during the study. history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation. anti-inflammatory treatments other than steroids (eg, complement inhibitor, anti-gm-csf antibody, anti-il6 antibody) are prohibited. however, antiviral drugs (eg, remdesivir,), systemic corticosteroids, and non steroidal anti inflammatory drugs (nsaids) are allowed. presence of any uncontrolled concomitant illness, serious illness, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with their participation in the study. major surgical procedure within 4 weeks prior to screening or anticipation of need for major surgical procedure during the course of the study. history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to screening history of organ allograft.

participation in any other clinical trial of an experimental treatment for covid-19 or participation in another interventional clinical trial, including an expanded access trial. concurrent treatment with other agents with actual or possible direct acting antiviral activity against sars cov 2 infection <24 hours prior to study drug dosing except for remdesivir. uncontrolled hypertension (systolic blood pressure >150 mmhg and/or diastolic blood pressure >100 mmhg), unstable angina, congestive heart failure of any new york respiratory association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment. hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine. renal function impairment (creatinine clearance [cr. cl.] <50 ml/min, based on modification of diet in renal disease calculation). liver function impairment alanine aminotransferase (alt) or aspartate aminotransferase (ast) >5 × upper limit of normal (uln), or alt/ast >3 × uln plus total bilirubin >2 × uln. total bilirubin >1.5 × uln, unless the subject has known gilbert's syndrome. platelet count <50 000/µl multi-organ failure. document active infection with a bacterial pathogen requiring parenteral systemic antibiotics. bacterial or fungal sepsis. history of live vaccination within the last 4 weeks prior to study enrollment; subjects must not receive live, attenuated influenza vaccine (eg, flumist) within 4 weeks before enrolment or at any time during the study. history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation. anti-inflammatory treatments other than steroids (eg, complement inhibitor, anti-gm-csf antibody, anti-il6 antibody) are prohibited. however, antiviral drugs (eg, remdesivir,), systemic corticosteroids, and non steroidal anti inflammatory drugs (nsaids) are allowed. presence of any uncontrolled concomitant illness, serious illness, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with their participation in the study. major surgical procedure within 4 weeks prior to screening or anticipation of need for major surgical procedure during the course of the study. history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to screening history of organ allograft.

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

1. participation in any other clinical trial of an experimental treatment for covid-19 or participation in another interventional clinical trial, including an expanded access trial. 2. concurrent treatment with other agents with actual or possible direct acting antiviral activity against sars cov 2 infection <24 hours prior to study drug dosing except for remdesivir. 3. uncontrolled hypertension (systolic blood pressure >150 mmhg and/or diastolic blood pressure >100 mmhg), unstable angina, congestive heart failure of any new york respiratory association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment. 4. hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine. 5. renal function impairment (creatinine clearance [cr. cl.] <50 ml/min, based on modification of diet in renal disease calculation). 6. liver function impairment 1. alanine aminotransferase (alt) or aspartate aminotransferase (ast) >5 × upper limit of normal (uln), or alt/ast >3 × uln plus total bilirubin >2 × uln. 2. total bilirubin >1.5 × uln, unless the subject has known gilbert's syndrome. 7. platelet count <50 000/µl 8. multi-organ failure. 9. document active infection with a bacterial pathogen requiring parenteral systemic antibiotics. 10. bacterial or fungal sepsis. 11. history of live vaccination within the last 4 weeks prior to study enrollment; subjects must not receive live, attenuated influenza vaccine (eg, flumist) within 4 weeks before enrolment or at any time during the study. 12. history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation. 13. anti-inflammatory treatments other than steroids (eg, complement inhibitor, anti-gm-csf antibody, anti-il6 antibody) are prohibited. however, antiviral drugs (eg, remdesivir,), systemic corticosteroids, and non steroidal anti inflammatory drugs (nsaids) are allowed. 14. presence of any uncontrolled concomitant illness, serious illness, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with their participation in the study. 15. major surgical procedure within 4 weeks prior to screening or anticipation of need for major surgical procedure during the course of the study. 16. history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to screening 17. history of organ allograft.

1. participation in any other clinical trial of an experimental treatment for covid-19 or participation in another interventional clinical trial, including an expanded access trial. 2. concurrent treatment with other agents with actual or possible direct acting antiviral activity against sars cov 2 infection <24 hours prior to study drug dosing except for remdesivir. 3. uncontrolled hypertension (systolic blood pressure >150 mmhg and/or diastolic blood pressure >100 mmhg), unstable angina, congestive heart failure of any new york respiratory association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment. 4. hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine. 5. renal function impairment (creatinine clearance [cr. cl.] <50 ml/min, based on modification of diet in renal disease calculation). 6. liver function impairment 1. alanine aminotransferase (alt) or aspartate aminotransferase (ast) >5 × upper limit of normal (uln), or alt/ast >3 × uln plus total bilirubin >2 × uln. 2. total bilirubin >1.5 × uln, unless the subject has known gilbert's syndrome. 7. platelet count <50 000/µl 8. multi-organ failure. 9. document active infection with a bacterial pathogen requiring parenteral systemic antibiotics. 10. bacterial or fungal sepsis. 11. history of live vaccination within the last 4 weeks prior to study enrollment; subjects must not receive live, attenuated influenza vaccine (eg, flumist) within 4 weeks before enrolment or at any time during the study. 12. history of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation. 13. anti-inflammatory treatments other than steroids (eg, complement inhibitor, anti-gm-csf antibody, anti-il6 antibody) are prohibited. however, antiviral drugs (eg, remdesivir,), systemic corticosteroids, and non steroidal anti inflammatory drugs (nsaids) are allowed. 14. presence of any uncontrolled concomitant illness, serious illness, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with their participation in the study. 15. major surgical procedure within 4 weeks prior to screening or anticipation of need for major surgical procedure during the course of the study. 16. history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to screening 17. history of organ allograft.