| Primary | Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8 | The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Count of Participants | | Participants | | Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| 1 . Not hospitalized, no new or increased limitations on activities | | | 2. Not. hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP | |
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2. | Proportional odds model | | 0.090 | | Odds Ratio (OR) | 0.64 | | | 2-Sided | 95 | 0.38 | 1.07 | | | Odds ratio greater than 1 favors Remdesivir plus Danicopan. | | |
|
| Secondary | Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories Through Day 29 | Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO from Day 1 through Day 29. Results are reported as Kaplan Meier estimates. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | |
|
| Secondary | Time to Sustained Recovery | Day of sustained recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the ordinal scale (and does not return to a score of 4 or higher up to and including study Day 60): 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized | Posted | | Median | 95% Confidence Interval | days | | Day 1 through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15 | The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized | Posted | | Count of Participants | | Participants | | Day 15 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29 | The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilationor extracorporeal membrane oxygenation (ECMO); 8) Death | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Count of Participants | | Participants | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Change From Baseline in C-Reactive Protein (CRP) | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | mg/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Ferritin | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | µg/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in D-dimer | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | µg/L fibrinogen equivalent units (FEU) | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Fibrinogen | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | mg/dL | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | U/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Aspartate Transaminase (AST) | Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | U/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Creatinine | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | mg/dL | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in International Normalized Ratio (INR) | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | Ratio | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Hemoglobin | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | g/dL | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Platelets Count | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Total Bilirubin | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | mg/dL | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in White Blood Cell (WBC) Count | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Neutrophils | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Median | Standard Deviation | 10^9 cells/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Eosinophils | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Basophils | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Lymphocytes | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Change From Baseline in Monocytes | Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Days 1, 3, 5, 8, 11, 15, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Number of Participants Reporting Grade 3 ,4, or 5 Clinical and/or Laboratory Adverse Events (AEs) | Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening while Grade 5 AEs are those that are fatal. Laboratory results were considered AEs if they were grade 3 or above according to the thresholds in the Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated. | Posted | | Count of Participants | | Participants | | Day 1 through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) | An SAE is defined as an AE or suspected adverse reaction that is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated. | Posted | | Count of Participants | | Participants | | Day 1 through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Number of Participants Who Discontinued or Temporarily Suspended Study Treatment | Discontinuation or temporary suspension of study product is defined as any episode of early discontinuation or interruption of study product administration. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated. | Posted | | Count of Participants | | Participants | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Duration of Hospitalization | Duration of hospitalization is defined first as the total number of days hospitalized for COVID-19, including readmissions for COVID-19-related reasons. It is also calculated as the total number of days hospitalized, including any readmissions for any reason. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Median | Inter-Quartile Range | days | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Duration of Intensive Care Unit (ICU) Stay | Duration of ICU is defined first as the total number of days spent in an intensive care unit. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Median | Inter-Quartile Range | days | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Days of Invasive Mechanical Ventilation/Extracorporeal Membrane Oxygenation (ECMO) Use | Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation or died. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Median | Inter-Quartile Range | days | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Days of New Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Use | Duration of new invasive mechanical ventilation/ECMO use was measured in days among participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis. | Posted | | Median | Inter-Quartile Range | days | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo |
|
| Secondary | Days of New Non-invasive Ventilation/High Flow Oxygen Use | Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants not on non-invasive ventilation/high flow oxygen at baseline who progressed to non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better at baseline were included in the analysis. | Posted | | Median | Inter-Quartile Range | days | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 |
|
| Secondary | Days of Non-invasive Ventilation/High Flow Oxygen Use | Duration of non-invasive ventilation or high flow oxygen use was measured in days among participants who required non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Median | Inter-Quartile Range | days | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Days of Supplemental Oxygen Use | Duration of supplemental oxygen use was measured in days among participants who required any supplemental oxygen, non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Median | Inter-Quartile Range | days | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use | New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use is defined as participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died during the study. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis. | Posted | | Count of Participants | | Participants | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo |
|
| Secondary | Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use | New Non-invasive Ventilation/High Flow Oxygen Use is defined as participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline who progressed to noninvasive ventilation/high flow oxygen, invasive ventilation/ECMO or died during the study. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better at baseline were included in the analysis. | Posted | | Count of Participants | | Participants | | Day 1 through Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | |
|
| Secondary | Mean Change in Ordinal Scale | The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities;2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Mean | Standard Deviation | units on a scale | | Days 1, 3, 5, 8, 11, 15, 22, 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
|
| Secondary | Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29 | Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Defined as the proportion of participants who were alive and were not hospitalized on invasive mechanical ventilation or ECMO at the Day 29 visit. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo |
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| Secondary | 14-day Participant Mortality | The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment. | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 1 through Day 15 | | | | ID | Title | Description |
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| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
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| Secondary | 28-day Participant Mortality | The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment. | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 1 through Day 29 | | | | ID | Title | Description |
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| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
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| Secondary | 59-day Participant Mortality | The mortality rate was determined as the proportion of participants who died by study Day 60. The proportions reported are Kaplan-Meier estimates. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment. | Posted | | Number | 95% Confidence Interval | Proportion of participants | | Day 1 through Day 60 | | | | ID | Title | Description |
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| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
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| Secondary | Time to an Improvement of One Category From Baseline Using an Ordinal Scale | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Median | 95% Confidence Interval | days | | Day 1 through Day 60 | | | | ID | Title | Description |
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| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
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| Secondary | Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale | The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death | The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. | Posted | | Median | 95% Confidence Interval | days | | Day 1 through Day 60 | | | | ID | Title | Description |
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| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
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| Secondary | Time to Death | The time death from study Day 1 to study Day 29, measured in days. The times reported are Kaplan-Meier estimates. | The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment. | Posted | | Median | 95% Confidence Interval | days | | Day 1 through Day 29 | | | | ID | Title | Description |
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| OG000 | Remdesivir + Danicopan | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). | | OG001 | Remdesivir + Placebo | 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants < 70 years or 300 mg PO for participants >=70 years(or via nasogastric [NG] or gastrostomy [G] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants <70years (200mg for participants>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for >=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for >=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). |
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