| Primary | Serum IL-6 Level | Change between baseline and 14 days post-randomization between placebo & ganciclovir groups | | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.79± 0.65
- OG001-0.79± 0.69
|
|
| |
| Secondary | Number of Participants With CMV Reactivation at 28 Days in Plasma | Number of participants in baseline negatives with CMV reactivation at any level at day 28 | | Posted | | Count of Participants | | Participants | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | BAL Levels of IL-6 | Levels of IL-6 from BALs at 7 days post-randomization | The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification. | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Number of Participants With Organ System Failure at 14 Days | Number of participants experiencing organ system failure at 14 days | | Posted | | Count of Participants | | Participants | | at 14 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Number of Days Alive and Not in the ICU | Number of ICU days alive and not in the ICU by day 28 | | Posted | | Mean | Standard Deviation | days | | by 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | CMV Disease | | | Posted | | Count of Participants | | Participants | | by 180 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Grade 3 AEs or Higher | Number of patients with greater than one AE of grade 3 or more | | Posted | | Count of Participants | | Participants | | by 35 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | SF-36 Health Survey | Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | | Posted | | Mean | Standard Deviation | scores on a scale | | at 1 day post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma | Number of participants with CMV reactivation >1,000 IU per mL at day 28 in plasma | | Posted | | Count of Participants | | Participants | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Incidence of CMV Reactivation at Any Level at 28 Days in Throat | CMV reactivation in baseline negatives at any level at day 28 in throat | | Posted | | Count of Participants | | Participants | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Incidence of CMV Reactivation >1,000 IU Per mL at 28 Days in Throat | Number of participants with CMV reactivation >1,000 IU per mL at day 28 in throat | | Posted | | Count of Participants | | Participants | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | CMV AUC in Blood | CMV AUC in blood from day 0 to day 28 | | Posted | | Mean | Standard Deviation | IU*day/mL | | Day 0 to 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | CMV AUC in Throat | CMV AUC in Throat from day 0 to day 28 | | Posted | | Mean | Standard Deviation | IU*day/mL | | Day 0 to 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | CMV Peak Viral Load in Blood | CMV Peak Viremia in blood at day 28 | | Posted | | Mean | Standard Deviation | log 10 IU/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | BAL Levels of IL-8 | Levels of IL-8 in BALs at day 7 | The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification. | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | BAL Levels of TNFa | Levels of TNFa in BALs at day 7 | The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification. | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of IL-6 | | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of IL-8 | Levels of IL-8 in plasma at day 7 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of TNF a | Plasma levels of TNF a at day 7.Cytokines are summarized on log 10 scale. When logged value is negative, the raw value would be less than 1. | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of TNF a | Plasma levels of TNF a from day 0 to day 28 | Cytokines are summarized on a log 10 scale. When the logged value is negative, the raw value would be less than 1. | Posted | | Mean | Standard Deviation | log 10 pg/mL | | Day 0 to 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of IL-6 | Plasma levels of IL-6 at day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of IL-8 | Plasma levels of IL-8 at day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of Soluble ICAM-1 | Plasma levels of soluble ICAM-1 at day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Plasma Levels of Soluble ICAM-1 | Plasma levels of soluble ICAM-1 at day 7 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Peak Plasma Levels of Soluble ICAM-1 | Peak Plasma levels of soluble ICAM-1 from day 0 to day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | Day 0 to 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Peak Plasma Levels of TNF-a | Peak Plasma levels of TNF-a at day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Peak Plasma Levels of IL-10 | Peak Plasma levels of IL-10 at day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Peak Plasma Levels of IL-8 | Peak Plasma levels of IL-8 at day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Peak Plasma Levels of IL-6 | Peak Plasma levels of IL-6 at day 28 | | Posted | | Mean | Standard Deviation | log 10 pg/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | AUC Plasma Levels of IL-6 | AUC Plasma levels of IL-6 from day 0 to day 28 | | Posted | | Mean | Standard Deviation | IU*day/mL | | Day 0 to 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | AUC Plasma Levels of IL-8 | AUC Plasma levels of IL-8 from day 0 to day 28 | | Posted | | Mean | Standard Deviation | IU*day/mL | | Day 0 to 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | AUC Plasma Levels of IL-10 | AUC Plasma levels of IL-10 from day 0 to day 28 | | Posted | | Mean | Standard Deviation | IU*day/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | AUC Plasma Levels of TNF-a | AUC Plasma levels of TNF-a from day 0 to day 28 | | Posted | | Mean | Standard Deviation | IU*day/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | AUC Plasma Levels of Soluble ICAM-1 | AUC Plasma levels of soluble ICAM-1 from day 0 to day 28 | | Posted | | Mean | Standard Deviation | IU*day/mL | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Length of Stay | Hospital days alive and not hospitalized by day 180 | | Posted | | Mean | Standard Deviation | days | | by 180 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Length of Stay | Hospital days alive and not hospitalized by day 28 | | Posted | | Mean | Standard Deviation | days | | by 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Organ System Failure at 28 Days | Number of participants with organ system failure at 28 days | | Posted | | Count of Participants | | Participants | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Duration of Mechanical Ventilation as Assessed by Ventilator Free Days | Number of days of mechanical ventilation duration as assessed by ventilator free days | | Posted | | Mean | Standard Deviation | days | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Duration of Mechanical Ventilation as Assessed by Ventilator Days | Number of days of mechanical ventilation duration as assessed by ventilator days | | Posted | | Mean | Standard Deviation | days | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Bacteremia and/or Fungemia | Number of participants with bacteremia and/or fungemia | | Posted | | Count of Participants | | Participants | | at 28 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Mortality | Mortality at 60 days post randomization | | Posted | | Count of Participants | | Participants | | at 60 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Mortality at 180 Days | Mortality at 180 days post-randomization | | Posted | | Count of Participants | | Participants | | at 180 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | SF-36 Functional Assessment Physical Component | Physical Component Summary at 180 days post- randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | | Posted | | Mean | Standard Deviation | scores on a scale | | at 180 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | SF-36 Functional Assessment Mental Component | Mental Component Summary at 180 days post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | | Posted | | Mean | Standard Deviation | scores on a scale | | at 180 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | SF-36 Functional Assessment Mental Component on Day 1 | SF-36 Mental Component Summary at 1 day post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | | Posted | | Mean | Standard Deviation | scores on a scale | | at 1 day post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Patients With Serious Adverse Events | Number of patients with Serious Adverse Events by day 35 | | Posted | | Count of Participants | | Participants | | by 35 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Time to Neutropenia | Time to neutropenia by 35 days post-randomization | | Posted | | Number | | days | | by 35 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Use of Granulocyte-colony Stimulating Factor | Number of participants requiring Granulocyte-colony stimulating factor | | Posted | | Count of Participants | | Participants | | by 35 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Renal Insufficiency | Number of patients experiencing a glomerular filtration rate < 60mL/min at day 35 | | Posted | | Count of Participants | | Participants | | by 35 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Red Blood Cell Transfusions Required Per Patients | Red blood cell transfusions required per patients by day 35 | | Posted | | Median | Inter-Quartile Range | transfusions | | by 35 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Platelet Transfusions | Platelet transfusions per patient | | Posted | | Median | Inter-Quartile Range | transfusions | | by 35 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Clinical Outcomes | Composite of survival status and >7 days ventilation status, and IL-6 levels. In the composite analysis, the endpoint is composed by death, ventilation status and change of cytokine. | | Posted | | Count of Participants | | Participants | | at 14 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
| |
| Secondary | Bacteremia and Fungemia Outcomes | Bacteremia and fungemia outcomes among subjects who survive at least 7 days | | Posted | | Number | | events | | at 7 days post-randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Bacteremia and Fungemia Outcomes in Mechanically Ventilated Subjets | Bacteremia and fungemia events among subjects who are mechanically ventilated for at least 7 through 14 days after randomization | | Posted | | Number | | events | | at 7 through 14 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Overall Mortality | Overall mortality amongst subjects who survive at least 7 days after randomization | | Posted | | Number | | events | | at 7 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Mechanical Ventilated Days | Number of mechanical ventilated days amongst subjects who survive at least 7 days after randomization | | Posted | | Mean | Standard Deviation | days | | at 7 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Ventilator-free Days | Number of ventilator-free days amongst subjects who survive at least 7 days after randomization | | Posted | | Mean | Standard Deviation | days | | at 7 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Days in the ICU | Number of days in the ICU amongst subjects who survive at least 7 days after randomization | | Posted | | Mean | Standard Deviation | days | | at 7 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of ICU-free Days | Number of ICU-free days amongst subjects who survive at least 7 days after randomization | | Posted | | Mean | Standard Deviation | days | | at 7 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Days in the Hospital | Number of days in the hospital amongst subjects who survive at least 7 days after randomization | | Posted | | Mean | Standard Deviation | days | | at 7 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Hospital-free Days | Number of hospital-free days amongst subjects who survive at least 7 days after randomization | | Posted | | Mean | Standard Deviation | days | | at 7 days post-randomization | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Mortality Among Subjects Mechanically Ventilated From Day 7 to 14 | Mortality among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization | | Posted | | Number | | events | | 28 days | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Mechanically Ventilated Days Among Subjects by Day 28 | Number of mechanically ventilated days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization | | Posted | | Mean | Standard Deviation | days | | 28 days | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Ventilator-free Days Among Subjects by Day 28 | Number of ventilator-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization | | Posted | | Mean | Standard Deviation | days | | 28 days | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Days in ICU Amongst Subjects by Day 28 | Number of days in ICU amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization | | Posted | | Mean | Standard Deviation | days | | 28 days | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of ICU-free Days Amongst Subjects by Day 28 | Number of ICU-free days amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization | | Posted | | Mean | Standard Deviation | days | | 28 days | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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| Secondary | Number of Hospital-free Days Among Subjects by Day 28 | Number of hospital-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization | | Posted | | Mean | Standard Deviation | days | | 28 days | | | | ID | Title | Description |
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| OG000 | IV Ganciclovir | 5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose. | | OG001 | Placebo | normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose. The placebo is an IV solution that does not contain any active medications. |
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