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

* participation in any other clinical trial of an experimental agent treatment. * requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ecmo) at the time of randomization. * has explicitly expressed the wish not to receive intensive care support (do not resuscitate or do not intubate order) should this become necessary. * in the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure. * requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than covid-19. * hypertensive urgency (e.g., sbp \>220 mmhg or dbp \>120 mmhg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines. * if has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines. * evidence of moderate or severe hepatic impairment (child-pugh class b or c). * estimated gfr (egfr) \<30 ml/min/1.73m2 (based on ckd-epi formula). * prior to a participant's study entry, known allergies or intolerance to brilacidin or formulation excipients. * any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study. * pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment. * sexually active males with female partners of childbearing potential unwilling to use a condom when engaging in intercourse of reproductive potential throughout the study and for up to 30 days after stopping treatment.

* participation in any other clinical trial of an experimental agent treatment. * requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ecmo) at the time of randomization. * has explicitly expressed the wish not to receive intensive care support (do not resuscitate or do not intubate order) should this become necessary. * in the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure. * requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than covid-19. * hypertensive urgency (e.g., sbp \>220 mmhg or dbp \>120 mmhg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines. * if has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines. * evidence of moderate or severe hepatic impairment (child-pugh class b or c). * estimated gfr (egfr) \<30 ml/min/1.73m2 (based on ckd-epi formula). * prior to a participant's study entry, known allergies or intolerance to brilacidin or formulation excipients. * any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study. * pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment. * sexually active males with female partners of childbearing potential unwilling to use a condom when engaging in intercourse of reproductive potential throughout the study and for up to 30 days after stopping treatment.

March 7, 2021, 12:31 a.m. usa

- participation in any other clinical trial of an experimental agent treatment. - requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ecmo) at the time of randomization. - has explicitly expressed the wish not to receive intensive care support (do not resuscitate or do not intubate order) should this become necessary. - in the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure. - requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than covid-19. - hypertensive urgency (e.g., sbp >220 mmhg or dbp >120 mmhg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines. - if has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines. - evidence of moderate or severe hepatic impairment (child-pugh class b or c). - estimated gfr (egfr) <30 ml/min/1.73m2 (based on ckd-epi formula). - prior to a participant's study entry, known allergies or intolerance to brilacidin or formulation excipients. - any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study. - pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment. - women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment. - sexually active males with female partners of childbearing potential unwilling to use a condom when engaging in intercourse of reproductive potential throughout the study and for up to 30 days after stopping treatment.

- participation in any other clinical trial of an experimental agent treatment. - requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ecmo) at the time of randomization. - has explicitly expressed the wish not to receive intensive care support (do not resuscitate or do not intubate order) should this become necessary. - in the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure. - requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than covid-19. - hypertensive urgency (e.g., sbp >220 mmhg or dbp >120 mmhg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines. - if has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines. - evidence of moderate or severe hepatic impairment (child-pugh class b or c). - estimated gfr (egfr) <30 ml/min/1.73m2 (based on ckd-epi formula). - prior to a participant's study entry, known allergies or intolerance to brilacidin or formulation excipients. - any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study. - pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment. - women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment. - sexually active males with female partners of childbearing potential unwilling to use a condom when engaging in intercourse of reproductive potential throughout the study and for up to 30 days after stopping treatment.