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

any signs indicative of severe or critical illness severity required hospitalization as defined below: severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment chronic diarrhea (excess of 2-3 stools/day above normal frequency) concomitant treatment with another investigational drug from day 1 through day 28. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

any signs indicative of severe or critical illness severity required hospitalization as defined below: severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment chronic diarrhea (excess of 2-3 stools/day above normal frequency) concomitant treatment with another investigational drug from day 1 through day 28. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

Aug. 17, 2021, 6 p.m. usa

1. any signs indicative of severe or critical illness severity required hospitalization as defined below: - severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 - critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure 2. pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) 3. active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment 4. chronic diarrhea (excess of 2-3 stools/day above normal frequency) 5. concomitant treatment with another investigational drug from day 1 through day 28. 6. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

1. any signs indicative of severe or critical illness severity required hospitalization as defined below: - severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 - critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure 2. pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) 3. active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment 4. chronic diarrhea (excess of 2-3 stools/day above normal frequency) 5. concomitant treatment with another investigational drug from day 1 through day 28. 6. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

July 21, 2021, 4 p.m. usa

any signs indicative of severe or critical illness severity required hospitalization as defined below: severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment chronic diarrhea (excess of 2-3 stools/day above normal frequency) concomitant treatment with another investigational drug from day 1 through day 28. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

any signs indicative of severe or critical illness severity required hospitalization as defined below: severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment chronic diarrhea (excess of 2-3 stools/day above normal frequency) concomitant treatment with another investigational drug from day 1 through day 28. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

Dec. 13, 2020, 12:31 a.m. usa

1. any signs indicative of severe or critical illness severity required hospitalization as defined below: - severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 - critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure 2. pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) 3. active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment 4. chronic diarrhea (excess of 2-3 stools/day above normal frequency) 5. concomitant treatment with another investigational drug from day 1 through day 28. 6. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

1. any signs indicative of severe or critical illness severity required hospitalization as defined below: - severe covid-19: shortness of breath in rest, or respiratory distress, respiratory rate (rr) >/= 30 per minute, heart rate (hr) >/=125 bpm, spo2</=93% on room air at sea level or pao2/fio2<300 - critical covid-19: respiratory failure required mechanical ventilation, oxygen delivered by high-flow nasal cannula, esmo; shock or multi-organ dysfunction/failure 2. pregnant or nursing women. (note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.) 3. active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment 4. chronic diarrhea (excess of 2-3 stools/day above normal frequency) 5. concomitant treatment with another investigational drug from day 1 through day 28. 6. current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.