Created at Source Raw Value Validated value
Dec. 22, 2021, 3 a.m. usa

any clinical signs indicative of severe or critical covid-19 as defined by fda guidance for industry at the time, including spo2 <93% and/or oxygen requirement hospitalization for covid-19, or consideration thereof icu level of care and/or non-mechanical/mechanical ventilation and/or oxygen supplementation at time of enrollment pregnant or breast-feeding subjects subjects who cannot swallow tablets history of any pre-existing organ impairment, such as: severe kidney disease (known or estimated gfr <30 ml/minute) or on dialysis uncontrolled, clinically significant heart diseases such as arrhythmias, angina or heart failure as defined by aha/acc grade c and d chronic respiratory disease requiring supplemental oxygen moderate and severe hepatic impairment as defined by child-pugh scoring class b and class c elevated liver function test (determined by alt, ast, ggt, or alp >2x upper limit of normal, and/or total bilirubin > upper limit of normal) history of malignancy or immunodeficiency within the prior 5 years acute respiratory illness other than covid-19 acute bacterial, viral or fungal infection (including hiv, hepatitis b, hepatitis c) while dosed with ip, the taking of prohibited concomitant medication or the ingestion of food that interferes with the ip, including: non-covid19-related anti-viral medication such as lopinavir, ritonavir, ribavirin, or interferon-1β systemically administered immunosuppressive and anti-inflammatory agents, other than background standard of care for covid-19 at the time drugs and foods that are potent inhibitors or inducers of cyp3a4 and/or p-gp, as listed in fda "drug development and drug interactions: table of substrates, inhibitors and inducers", including herbal medications such as st. john's wort within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug any other diseases or medical conditions or concomitant medications that are deemed as not compatible or appropriate for the subject's ability to fully and safely participate in this trial as determined by the investigator

any clinical signs indicative of severe or critical covid-19 as defined by fda guidance for industry at the time, including spo2 <93% and/or oxygen requirement hospitalization for covid-19, or consideration thereof icu level of care and/or non-mechanical/mechanical ventilation and/or oxygen supplementation at time of enrollment pregnant or breast-feeding subjects subjects who cannot swallow tablets history of any pre-existing organ impairment, such as: severe kidney disease (known or estimated gfr <30 ml/minute) or on dialysis uncontrolled, clinically significant heart diseases such as arrhythmias, angina or heart failure as defined by aha/acc grade c and d chronic respiratory disease requiring supplemental oxygen moderate and severe hepatic impairment as defined by child-pugh scoring class b and class c elevated liver function test (determined by alt, ast, ggt, or alp >2x upper limit of normal, and/or total bilirubin > upper limit of normal) history of malignancy or immunodeficiency within the prior 5 years acute respiratory illness other than covid-19 acute bacterial, viral or fungal infection (including hiv, hepatitis b, hepatitis c) while dosed with ip, the taking of prohibited concomitant medication or the ingestion of food that interferes with the ip, including: non-covid19-related anti-viral medication such as lopinavir, ritonavir, ribavirin, or interferon-1β systemically administered immunosuppressive and anti-inflammatory agents, other than background standard of care for covid-19 at the time drugs and foods that are potent inhibitors or inducers of cyp3a4 and/or p-gp, as listed in fda "drug development and drug interactions: table of substrates, inhibitors and inducers", including herbal medications such as st. john's wort within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug any other diseases or medical conditions or concomitant medications that are deemed as not compatible or appropriate for the subject's ability to fully and safely participate in this trial as determined by the investigator