Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

Efficacy Endpoint: Proportion of patients showing 2 points improvement as per <br/ >WHO ordinal scale and mortality after 14 days of treatment. <br/ >Safety Endpoints: <br/ >Incidence of new bacterial; fungal; or opportunistic infection <br/ >Incidence of Grade 4 neutropenia (absolute neutrophil count [ANC] less than 500 per mm3) <br/ >Incidence of Grade 3-4 adverse events ([AEs]; clinical orlaboratory) <br/ >Incidence of serious adverse events (SAEs) <br/ >Incidence of abnormal electrocardiograms (ECGs) requiring clinical action <br/ >Proportion of patients with shock defined by persistent hypotension (systolic blood pressure (SBP) less than 90 mmHg or diastolic blood pressure (DBP) less than 60 mmHg) despite volume resuscitation; requiring vasopressors to maintain MAP greater than or equal to 65 mmHg and serum lactate level greater than 2mmol per L. <br/ >Timepoint: PD Blood Collection on Day 01; 04; 08; 15; 29; 58.

Efficacy Endpoint: Proportion of patients showing 2 points improvement as per <br/ >WHO ordinal scale and mortality after 14 days of treatment. <br/ >Safety Endpoints: <br/ >Incidence of new bacterial; fungal; or opportunistic infection <br/ >Incidence of Grade 4 neutropenia (absolute neutrophil count [ANC] less than 500 per mm3) <br/ >Incidence of Grade 3-4 adverse events ([AEs]; clinical orlaboratory) <br/ >Incidence of serious adverse events (SAEs) <br/ >Incidence of abnormal electrocardiograms (ECGs) requiring clinical action <br/ >Proportion of patients with shock defined by persistent hypotension (systolic blood pressure (SBP) less than 90 mmHg or diastolic blood pressure (DBP) less than 60 mmHg) despite volume resuscitation; requiring vasopressors to maintain MAP greater than or equal to 65 mmHg and serum lactate level greater than 2mmol per L. <br/ >Timepoint: PD Blood Collection on Day 01; 04; 08; 15; 29; 58.