Created at Source Raw Value Validated value
June 25, 2024, noon usa

* the participant, in the opinion of the investigator, is not likely to survive for \>=48 hours beyond day 1 * has a diagnosis of asymptomatic covid-19, mild covid-19, or critical covid-19 on day 1 * has a documented current liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) at screening or on day 1 * has a child pugh score \>= c * has a documented medical history of infection with human immunodeficiency virus or hepatitis a, b, or c at screening or on day 1 * has a documented active infection with tuberculosis at screening or on day 1 * has clinically significant ecg abnormalities at screening or on day 1 * requires dialysis or is on any renal replacement therapies at screening or on day 1 * a female participant who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening * receiving alpha-blockers, combined alpha/beta blockers, antihistamines, or any drugs that will affect the levels of cytokines released due to immune stress * has received any immunoglobulins within 6 months of screening or planned administration of any immunoglobulins during the screening and/or treatment periods * has a known history of drug abuse within 6 months of study start that would interfere with the participant's participation in the study * has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation * has participated in and/or plan to participate in another clinical study * will be transferred to another hospital which is not a study site within 72 hours * cannot read and speak either english or spanish other protocol defined inclusion/exclusion criteria may apply

* the participant, in the opinion of the investigator, is not likely to survive for \>=48 hours beyond day 1 * has a diagnosis of asymptomatic covid-19, mild covid-19, or critical covid-19 on day 1 * has a documented current liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) at screening or on day 1 * has a child pugh score \>= c * has a documented medical history of infection with human immunodeficiency virus or hepatitis a, b, or c at screening or on day 1 * has a documented active infection with tuberculosis at screening or on day 1 * has clinically significant ecg abnormalities at screening or on day 1 * requires dialysis or is on any renal replacement therapies at screening or on day 1 * a female participant who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening * receiving alpha-blockers, combined alpha/beta blockers, antihistamines, or any drugs that will affect the levels of cytokines released due to immune stress * has received any immunoglobulins within 6 months of screening or planned administration of any immunoglobulins during the screening and/or treatment periods * has a known history of drug abuse within 6 months of study start that would interfere with the participant's participation in the study * has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation * has participated in and/or plan to participate in another clinical study * will be transferred to another hospital which is not a study site within 72 hours * cannot read and speak either english or spanish other protocol defined inclusion/exclusion criteria may apply

Nov. 7, 2020, 11:31 p.m. usa

- the participant, in the opinion of the investigator, is not likely to survive for >=48 hours beyond day 1 - has a diagnosis of asymptomatic covid-19, mild covid-19, or critical covid-19 on day 1 - has a documented current liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) at screening or on day 1 - has a child pugh score >= c - has a documented medical history of infection with human immunodeficiency virus or hepatitis a, b, or c at screening or on day 1 - has a documented active infection with tuberculosis at screening or on day 1 - has clinically significant ecg abnormalities at screening or on day 1 - requires dialysis or is on any renal replacement therapies at screening or on day 1 - a female participant who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening - receiving alpha-blockers, combined alpha/beta blockers, antihistamines, or any drugs that will affect the levels of cytokines released due to immune stress - has received any immunoglobulins within 6 months of screening or planned administration of any immunoglobulins during the screening and/or treatment periods - has a known history of drug abuse within 6 months of study start that would interfere with the participant's participation in the study - has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation - has participated in and/or plan to participate in another clinical study - will be transferred to another hospital which is not a study site within 72 hours - cannot read and speak either english or spanish other protocol defined inclusion/exclusion criteria may apply

- the participant, in the opinion of the investigator, is not likely to survive for >=48 hours beyond day 1 - has a diagnosis of asymptomatic covid-19, mild covid-19, or critical covid-19 on day 1 - has a documented current liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) at screening or on day 1 - has a child pugh score >= c - has a documented medical history of infection with human immunodeficiency virus or hepatitis a, b, or c at screening or on day 1 - has a documented active infection with tuberculosis at screening or on day 1 - has clinically significant ecg abnormalities at screening or on day 1 - requires dialysis or is on any renal replacement therapies at screening or on day 1 - a female participant who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening - receiving alpha-blockers, combined alpha/beta blockers, antihistamines, or any drugs that will affect the levels of cytokines released due to immune stress - has received any immunoglobulins within 6 months of screening or planned administration of any immunoglobulins during the screening and/or treatment periods - has a known history of drug abuse within 6 months of study start that would interfere with the participant's participation in the study - has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation - has participated in and/or plan to participate in another clinical study - will be transferred to another hospital which is not a study site within 72 hours - cannot read and speak either english or spanish other protocol defined inclusion/exclusion criteria may apply