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

* inability to supply direct informed consent from patient or from next of kin or independent healthcare provider on behalf of patient * invasive mechanical ventilation at time of screening * contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients * currently on any of the study investigational medicinal products * concurrent participation in an interventional clinical trial (observational studies allowed) * patient moribund at presentation or screening * pregnancy at screening * unwilling to stop breastfeeding during treatment period * known severe hepatic impairment (with or without cirrhosis) * requiring dialysis cockcroft gault estimated creatinine clearance \< 30 ml /min/1.73m2 at screening * inability to swallow at screening visit * any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. edp1815-specific

* inability to supply direct informed consent from patient or from next of kin or independent healthcare provider on behalf of patient * invasive mechanical ventilation at time of screening * contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients * currently on any of the study investigational medicinal products * concurrent participation in an interventional clinical trial (observational studies allowed) * patient moribund at presentation or screening * pregnancy at screening * unwilling to stop breastfeeding during treatment period * known severe hepatic impairment (with or without cirrhosis) * requiring dialysis cockcroft gault estimated creatinine clearance \< 30 ml /min/1.73m2 at screening * inability to swallow at screening visit * any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. edp1815-specific

June 12, 2021, 12:32 a.m. usa

- inability to supply direct informed consent from patient or from next of kin or independent healthcare provider on behalf of patient - invasive mechanical ventilation at time of screening - contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients - currently on any of the study investigational medicinal products - concurrent participation in an interventional clinical trial (observational studies allowed) - patient moribund at presentation or screening - pregnancy at screening - unwilling to stop breastfeeding during treatment period - known severe hepatic impairment (with or without cirrhosis) - requiring dialysis cockcroft gault estimated creatinine clearance < 30 ml /min/1.73m2 at screening - inability to swallow at screening visit - any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. edp1815-specific

- inability to supply direct informed consent from patient or from next of kin or independent healthcare provider on behalf of patient - invasive mechanical ventilation at time of screening - contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients - currently on any of the study investigational medicinal products - concurrent participation in an interventional clinical trial (observational studies allowed) - patient moribund at presentation or screening - pregnancy at screening - unwilling to stop breastfeeding during treatment period - known severe hepatic impairment (with or without cirrhosis) - requiring dialysis cockcroft gault estimated creatinine clearance < 30 ml /min/1.73m2 at screening - inability to swallow at screening visit - any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. edp1815-specific

Oct. 26, 2020, 11:31 p.m. usa

- inability to supply direct informed consent from patient or from next of kin or independent healthcare provider on behalf of patient - invasive mechanical ventilation at time of screening - contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients - currently on any of the study investigational medicinal products - concurrent participation in an interventional clinical trial (observational studies allowed) - patient moribund at presentation or screening - pregnancy at screening - unwilling to stop breastfeeding during treatment period - known severe hepatic impairment (with or without cirrhosis) - stage 4 severe chronic kidney disease or requiring dialysis (i.e. cockcroft gault estimated creatinine clearance < 30 ml /min) - inability to swallow at screening visit - any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. edp1815-specific

- inability to supply direct informed consent from patient or from next of kin or independent healthcare provider on behalf of patient - invasive mechanical ventilation at time of screening - contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients - currently on any of the study investigational medicinal products - concurrent participation in an interventional clinical trial (observational studies allowed) - patient moribund at presentation or screening - pregnancy at screening - unwilling to stop breastfeeding during treatment period - known severe hepatic impairment (with or without cirrhosis) - stage 4 severe chronic kidney disease or requiring dialysis (i.e. cockcroft gault estimated creatinine clearance < 30 ml /min) - inability to swallow at screening visit - any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. edp1815-specific