Created at Source Raw Value Validated value
Nov. 19, 2021, 7:30 p.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)