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

* clinical signs indicative of covid-19 illness requiring hospitalization * admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to covid-19 * in the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization * treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization * treatment with a covid-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against sars-cov-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against sars cov-2 or interleukin 6 (il-6), intravenous immunoglobulin or other eua-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit * concomitant use of p-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol * known allergy or hypersensitivity to components of study drug * abnormal laboratory test results at screening * requirement of any prohibited medications during the study * other known active viral or bacterial infection at the time of screening, such as influenza * any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study * covid-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)

* clinical signs indicative of covid-19 illness requiring hospitalization * admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to covid-19 * in the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization * treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization * treatment with a covid-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against sars-cov-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against sars cov-2 or interleukin 6 (il-6), intravenous immunoglobulin or other eua-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit * concomitant use of p-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol * known allergy or hypersensitivity to components of study drug * abnormal laboratory test results at screening * requirement of any prohibited medications during the study * other known active viral or bacterial infection at the time of screening, such as influenza * any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study * covid-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)

July 16, 2021, 6 a.m. usa

- clinical signs indicative of covid-19 illness requiring hospitalization - admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to covid-19 - in the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization - treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization - treatment with a covid-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against sars-cov-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against sars cov-2 or interleukin 6 (il-6), intravenous immunoglobulin or other eua-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit - concomitant use of p-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol - known allergy or hypersensitivity to components of study drug - abnormal laboratory test results at screening - requirement of any prohibited medications during the study - other known active viral or bacterial infection at the time of screening, such as influenza - any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study - covid-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)

- clinical signs indicative of covid-19 illness requiring hospitalization - admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to covid-19 - in the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization - treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization - treatment with a covid-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against sars-cov-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against sars cov-2 or interleukin 6 (il-6), intravenous immunoglobulin or other eua-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit - concomitant use of p-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol - known allergy or hypersensitivity to components of study drug - abnormal laboratory test results at screening - requirement of any prohibited medications during the study - other known active viral or bacterial infection at the time of screening, such as influenza - any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study - covid-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)

May 19, 2021, 12:31 a.m. usa

- clinical signs indicative of covid-19 illness requiring hospitalization - admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to covid-19 - in the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization - treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization - treatment with a covid-19 therapeutic agent against sars-cov-2 including, but not limited to, other direct or indirect acting antivirals, dexamethasone, interferons, convalescent plasma, monoclonal antibodies against sars cov-2, intravenous immunoglobulin or other emergency use authorization-approved treatments within the last 2 weeks prior to the screening visit - concomitant use of p-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol - known allergy or hypersensitivity to components of study drug - abnormal laboratory test results at screening - requirement of any prohibited medications during the study - known active viral or bacterial infection at the time of screening - any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study

- clinical signs indicative of covid-19 illness requiring hospitalization - admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to covid-19 - in the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization - treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization - treatment with a covid-19 therapeutic agent against sars-cov-2 including, but not limited to, other direct or indirect acting antivirals, dexamethasone, interferons, convalescent plasma, monoclonal antibodies against sars cov-2, intravenous immunoglobulin or other emergency use authorization-approved treatments within the last 2 weeks prior to the screening visit - concomitant use of p-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol - known allergy or hypersensitivity to components of study drug - abnormal laboratory test results at screening - requirement of any prohibited medications during the study - known active viral or bacterial infection at the time of screening - any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study